WO1991009521A1 - Identification process and related method for use in preparing a biological sample - Google Patents

Identification process and related method for use in preparing a biological sample Download PDF

Info

Publication number
WO1991009521A1
WO1991009521A1 PCT/US1990/007583 US9007583W WO9109521A1 WO 1991009521 A1 WO1991009521 A1 WO 1991009521A1 US 9007583 W US9007583 W US 9007583W WO 9109521 A1 WO9109521 A1 WO 9109521A1
Authority
WO
WIPO (PCT)
Prior art keywords
segment
method recited
umbilical
umbilical cord
individual
Prior art date
Application number
PCT/US1990/007583
Other languages
French (fr)
Inventor
Daniel D. Richard
Original Assignee
Cryo-Cell International, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cryo-Cell International, Inc. filed Critical Cryo-Cell International, Inc.
Publication of WO1991009521A1 publication Critical patent/WO1991009521A1/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A01N1/0278—Physical preservation processes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/42—Low-temperature sample treatment, e.g. cryofixation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/566—Immunoassay; Biospecific binding assay; Materials therefor using specific carrier or receptor proteins as ligand binding reagents where possible specific carrier or receptor proteins are classified with their target compounds
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/80—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types or red blood cells

Definitions

  • This invention relates to a method for use in identifying a person and more particularly in medically identifying a person.
  • This invention also relates to a method for preparing for use a biological sample, for ultimate use in an identification process, medical research, or a therapeutic treatment.
  • the invention also relates to a method for therapeutically treating a patient. More particularly, the instant invention relates to utilization of the umbilical cord in identification, medical research and therapeutic techni ⁇ ques.
  • the human umbilical cord reaches a length of 35 to 50 cm at term and includes two umbilical artieries and a single umbilical vein.
  • the vein carries oxygenated blood from the placenta to the fetus.
  • the arteries and the vein are embedded in a mucous connective tissue in turn covered by an epithelium which is multilayered at birth.
  • the connective tissue includes interlacing bundles of collagen fibers having intercellular spaces filled with a gelatinous substance known as Wharton's jelly.
  • the cells of the connective tissue are a primitive form of fibroblast, have easily detectable nucleii and are rich in collagen.
  • the umbilical arteries have rela ⁇ tively thick muscular walls containing a diffuse network of elastic fibers.
  • the umbilical cord like the placenta, is discarded after birth. However, it has been dis ⁇ covered that at least certain constituents of the umbilical cord may have a special usefulness.
  • physicians used the blood cells from the umbilical cord of an infant to aid in the regeneration of the stem cells in an older sibling. The blood was separated from the umbilical cord, subsequently frozen, and stored for seven months prior to infusion. Upon thawing, the cells were intravenously infused into the body of the recipient youngster.
  • This technique provides several advantages over conventional marrow transplantation. Using the cord blood in this instance enabled transplant as soon as a compatible sibling was born, while candidates for marrow transplant generally must wait until the newborn is at least six months old. In addition, the procedure eliminates for the donor the pain of marrow extraction.
  • An object of the present invention is to provide a method for use in identification procedures.
  • Another object of the present invention is to pro ⁇ vide a method for obtaining medical identification information for individuals upon birth and, additionally, for medically identifying individuals at birth.
  • Another, more particular, object of the present invention is to provide such a method wherein the medical identification information is biological or biochemical in nature.
  • Another object of the present invention is to pro ⁇ vide a method for obtaining medical identification information and aiding in medical research and therapeutic treatment, by a nohinvasive procedure which is less painful than other meth ⁇ ods.
  • Yet another object of the present invention is to provide a method for obtaining medical identification informa ⁇ tion and aiding in medical research and therapeutic treatment tyhich is less expensive than other methods.
  • An additional object of the present invention is to provide a method for preparing for use a biological sample.
  • the sample can be ultimately used in an identification process, medical research or a therapeutic treatment.
  • Yet another object of the present invention is to provide a method for therapeutically treating a patient.
  • Another, more particular, object of the present invention is to provide a method utilizing the umbilical cord in identification, medical research and therapeutic techni ⁇ ques.
  • Yet another particular object of the present inven ⁇ tion is to provide a method for use in typing the contents of the umbilical cord.
  • a further particular object of the present invention is to provide a method for gathering and storing the contents of umbilical cords in each typed category.
  • This invention pertains to the typing of the con ⁇ tents of umbilical cords ("umbilityping") and to using specific values of umbilical cord parameters (“umbilifica ⁇ tion”) for medical identification and/or research information.
  • Umbilification technology entails the preservation and storage of umbilical cords of the world's newborn population for pur ⁇ poses of identification and enhancement of their medical well being.
  • a method for preparing for use a biological sample, ultimately for such purposes as individual medical identifica ⁇ tion, research or therapeutic treatment of a patient, com ⁇ prises in accordance with the present invention, the steps of (a) upon the birth of an infant, obtaining at least a segment of the infant's severed umbilical cord, (b) preserving at least a portion of the obtained umbilical segment, (c) record ⁇ ing statistics pertaining to the individual and the individ ⁇ ual's birth, together with an identification of the preserved umbilical segment, and (d) conveying the umbilical segment to a storage facility.
  • the recorded statistics include, for example, the infant's name and weight and his or her genetic heritage, including genetic predispositions to certain dis ⁇ eases.
  • the step of preserving includes the step of closing opposite ends of the umbilical segment.
  • the closing is preferably accomplished by tying off both ends of the segment.
  • the segment may be placed in a respective container or receptacle, such as a box, bag or ampule, which may carry on an external surface a bar code readable by a laser or other type scanner. If the umbilical cord segment is not stored in a respective container, the opposite ends of the severed segment may, for example, be cov ⁇ ered with respective end caps made of a material suitable for the use of a bar code and laser scanner.
  • the step of preserving may include the step of cooling the umbilical segment.
  • the umbilical segment is frozen and preserved cryogenically.
  • the storage facility is a cryogenic storage facility.
  • the preser ⁇ vation may be accomplished by immersion of the segments in a bath of liquid nitrogen or supercooled carbon dioxide, or by placing the segments in respective thin-walled containers and placing the containers in contact with a chlorofluorocarbon mixture.
  • the invention contemplates utilization of the preservation technique best suited to mini ⁇ mize destruction of the cellular contents of the umbilical cord.
  • the umbilification storage facility can be centrally located and serve, for example, several hospitals all in the same city, county or state. In some instances, however, the storage facility may be a small unit, perhaps even portable, located on the hospital premises.
  • the recorded statistics are transmitted to an information storage facility.
  • that storage facility is at the same location as the cryogenic storage apparatus.
  • the personal history information is not transferred or stored.
  • the stored umbilical cord segments may in that case neverthe ⁇ less be used for research wherein the identity of the infant is immaterial.
  • the umbilical cord may be severed into a multiplicity of segments, each of the segments is closed at opposite ends thereof, for example, by tying or otherwise clamping, and then the closed or sealed segments are separately preserved, for example, by freezing.
  • the segments may be of various sizes.
  • a method for preparing for use a biological sample, ultimately for such purposes as individual identi ication, research or therapeutic treatment comprises the steps of (a) upon the birth of an infant, obtaining a segment of the infant's umbilical cord, (b) closing both ends of the segment in preparation for its preservation, (c) preserving (e.g., by freezing or freeze-drying) the segmented umbilical cord so that its biological components can be utilized for medical identification, research and/or therapeutic treatment of patients, and (d) recording statistics pertaining to the indi ⁇ vidual and the individual's birth, as well as pertinent family information, together with an identification of the preserved umbilical segment.
  • the preserved umbilical segment is in most cases stored for possible future use of its biological, histological, cellular and biochemical components.
  • a method in accordance with the present invention including the steps of severing, closing, freezing, and recording, is performed for each individual infant born in a health care institution and preferably in an entire state or country.
  • a replication e.g., in vitro replication
  • the preserved and stored umbilical cords can be of great medical benefit to the respective individuals.
  • autologous hematopoietic reconstitution can be effectuated in an adult patient, using umbilical cord blood cells stored in the preserved umbilical cord at the time the patient was an infant.
  • the value of umbilification technology accordingly increases. Because of the vast numbers of umbilical cords stored then in each typed classification, allogeneic hematopoietic reconstitution may be implemented, without the utilization of replication technology.
  • the stored materials can be retrieved and expanded and used in syngeneic transplants without a need for aspirating marrow from donating siblings. All of these procedures in hematopoietic reconstitution can be implemented without pain or with less pain than is currently experienced in transp1antology.
  • Embodiments of the instant invention contemplate the monitoring of incoming requests for preserved and stored materials.
  • the identified umbilical cord segment can be retrieved from the storage apparatus and can be conveyed to the appropriate loca ⁇ tion.
  • At least a portion of a preserved umbilical cord segment is received and treated to isolate a kind of biological material.
  • the biological material is analyzed to determine values of a plurality of predetermined biochemical parameters.
  • information recorded at the birth of an individual attached to an umbilical cord from which the umbilical cord segment was severed and subsequently preserved is received.
  • the information includes statistics pertaining to the individ ⁇ ual and the individual's birth, together with an identifica ⁇ tion of the preserved umbilical cord segment.
  • the received recorded information and the determined values of the predetermined biochemical parameters are then stored for future reference.
  • the umbilical parameters for which specific values (the umbilitype) are determined may include, for exam ⁇ ple, blood type, tissue type or composition of genetic materials or any other materials contianed within the umbili- cai cord.
  • the step of isolating includes the steps of separating out genetic material from cells of the person, the step of analyzing including the step of comparing the composi ⁇ tion of the separated genetic material with known genetic com ⁇ positions to determine at least in part a genetic structure of the individual.
  • a method for therapeutically treating a patient com ⁇ prises in accordance with the present invention, the steps of (a) receiving at least a portion of a preserved umbilical cord segment from a storage facility, (b) isolating a biological component of the portion of the umbilical cord segment, and (c) using the isolated component to treat the patient.
  • the umbilical cord segment is preferably cryopreserved, the storage facility being a cryogenic storage facility. Then, a further step includes warming the portion of the umbilical cord segment.
  • the step of using the isolated component to treat the patient includes the step of infusing the cellular material into the patient.
  • the cell may exemplarily take the form of a stem cell from the blood of the preserved umbilical cord seg ⁇ ment and is infused intraveously into a patient suffering from a blood or blood marrow disorder.
  • an appropriate isolated umbilical cord blood cell will have been replicated in vitro by others.
  • umbilical cords serve as a universal procedure for obtaining information for purposes of medical identification.
  • umbilical cord segments are stored in greater numbers and are typed for their tissue, cellular and biochemi ⁇ cal characteristics ("umbilityping") , a valuable bank is created which stores:
  • blood cells for example, stem cells and progenitor cells for hematopoietic reconstitution, both autologous and major histocompatibility complex-matched;
  • This bank of medical information and materials for therapeutic treatment is collected in a noninvasive manner without pain to the individual. Moreover, the information and biological materials are collected by a method which is less expensive than other methods, for example, extracting blood fro newborn babies, which requires a medical examination of the infant to determine whether it can safely withstand the extrac ⁇ tion procedure.
  • the individual umbilical cords are typed into categories. As the members of typed cel ⁇ lular material in each category increases, it will eventually b possible to utilize the accumulated cellular materials in each category for allogeneic hematopoietic reconstitution. This is important insofar as it permits therapeutic treatment of adults without the need for replication technology.
  • a bank of biological, histological and biochemical materials formed in accordance with the present invention may include both diseased cells and healthy cells.
  • the storage of healthy cells is the primary purpose an effect of the invention, on those occasions where diseasedcells are stored, the diseased cells may be useful for research pur ⁇ poses.
  • the diseased cells may be useful for research pur ⁇ poses.
  • umbilical cords from infants born within a pres ⁇ cribed territory a city, county, state or an entire country
  • a sectioned, preserved and stored Also stored is information pertaining to each individual such as the infant's name, birth statistics and any pertinent information as to genetic predisposition to certain diseases.
  • the preserved umbilical cords or portions thereof are subsequently made available for medical identification, research purposes or therapeutic treat ⁇ ment upon proper request.
  • umbili ⁇ cal cord is severed into one or more segments.
  • the severing may be, accomplished by any known technique. See, for example, U.S. Patent No. 4,648,401 to Philip D. Mattson, the disclosure of which is incorporated by reference herein.
  • the ends o the segment are closed to retain all biological materials ontained within the umbilical cord.
  • the closure may be accomplished by tying or with synthetic resin end caps or other clamps, or otherwise sealed.
  • the closure procedure is imple ⁇ mented on a free end of the umbilical cord segment while that e is clamped by a hemostat or other instrument.
  • the ends of an umbilical cord are dipped into a cryogenic bath to close the ends by freezing.
  • the umbilical cord segments may be washed, preferably prior to sectioning of the cord to minimize the loss of umbilic cord blood. Alternatively, each segment may be washed subse ⁇ quently to the sealing of the ends.
  • each segment is then preserved preferably by immersion in a cryogenic coolant such as liquifie nitrogen.
  • a cryogenic coolant such as liquifie nitrogen.
  • a sealed umbilical cord section is first placed in a suitable thin walled container such as a polyethylene bag or vial. The container is then immersed in a low-temperature fluid.
  • a fluid may take the form of liqui nitrogen, liquid carbon dioxide or a chlorofluorocarbon mixture such as those described in U.S. Patent No. 4,803,842 to Coehlo, the disclosure of which is incorporated by reference herein.
  • the umbilical cord segments may also be preserved by other techniques, such as freeze drying. Freeze-drying is generally not preferred because of the effects of the freeze- drying process on structures of various biological components such as cell membranes. However, inasmuch as certain biochemic components such as DNA, RNA and various proteins may be stored intact by a freeze-drying technique, preservation of at least o segment of each umbilical cord by freeze-drying may be useful.
  • Liposome preparations are dehydrated und reduced pressure in the presence of one or more sugars, preferably the disaccharides trehalose and sucrose.
  • the amount of the sugars used depends on the type of sugar and on the char acteristics of the liposomes to be protected. Freezing of the lipopsomes prior to dehydration is optional.
  • various constituten s, for exam ⁇ ple, blood and endothelial vein cells, of an umbilical cord are isolated from an umbilical -cord.sample at the birth of an infan
  • the constituents are analyzed and typed according to known meth ods.
  • the blood type, the blood protein concentra ⁇ tions, the karyotype, the H A and other factors are all determined and recorded.
  • These umbilical cord parameters are included in the general statistical information pertaining to t personal history of the individual, including his or her name, parentage, birth date, weight, sex, etc., which is generally co lected by a health care institution such as a hospital.
  • the umbilification information is transmitted, together with the pe sonal history statistics, to an information storage facility.
  • the information is preferably encoded in digital form and is transmitted via a communications link (telephone, wireless, satellite) to the storage facility, which is preferably a genera purpose computer.
  • the computer is an information repository containing all the umbilification and personal history information for all individuals born after a certain date in the prescribed area (a hospital, a city, a county, several counties, a state, several states or an entire country) .
  • the stored information includes, for each parcel of umbilification and personal history infor a- tion, the location of the individual's umbilical cord segment or segments.
  • the cryogenic storage facility is repository containing umbilical cord segments for all individual born after the prescribed date in the prescribed locale.
  • the computer and the cryogenic storage facility may be in the same location, the computer serving in part to monitor and memorize the locations of the cryopreserved umbilical cord segments in th cryogenic storage facility.
  • the cryogenic storage facility advantageously takes the form of the apparatus disclosed and claimed in copending U.S. Patent Application Serial No. 389,543 filed August 4, 1989 by Hermann Knippscheer and Daniel D. Richard, the disclosure of which is hereby incorporated by :reference.
  • umbilical cord segment for each newborn individual are prepared and transferred to the cryogenic repository for future utilization under different cir ⁇ cumstances.
  • one or more segments for each individual are sent to a second, back-up facility essentially duplicating the umbilical cord and informa ⁇ tion contents of the first cryogenic/information storage facility.
  • Umbilical cord segments are maintained in a cryopreserved or freeze-dried state at a cryogenic storage facility for an indefinite period.
  • the facility receives requests for items stored at the facility.
  • umbilical cor blood includes hematopoietic stem and multipotential (CFU-GEMM) , crythroid (BFU-E) , and granulocyte-macrophage (CFU-GM) progenito cells utilizable in hematopoietic reconsitution as an und to bone marrow transplantation.
  • CFU-GEMM hematopoietic stem and multipotential
  • BFU-E crythroid
  • CFU-GM granulocyte-macrophage
  • Hematopoietic Reconstitution __n a Patient With Fanconi's Anemia by Means of umbilical cord blood From an HLA-Identical Sibling
  • Elaine Gluckman et al. New England Journal of Medicine, Vol. 321, No. 17, pp. 1174-78 (•Oct.
  • cryopreserved umbili cal cord blood was thawed and infused into the patient without further processing.
  • the blood had been obtained from the sister's umbilical cord and the placenta and transported at ambient temperature by overnight courier to a laboratory for analysis, cryopreservation and storage.
  • the bloo was frozen in dimethyl sulfide at a final concentration of 10 percent.
  • Upon thawing of the umbilical cord blood it was found that eighty-two percent of the nucleated cells were viable.
  • other conditions for which bone marrow transplant is indicated may be treated with th use of cord blood.
  • blood from cyropreserved umbilical cord segments may be used, in accordance with the invention, in bone marrow reconstitution.
  • the determined umbilification information i transmitted to the information repository, where it is compared with the digitally stored blood type and other information pertinent to stored umbilical cord segments.
  • the corresponding umbilical cord segment is transferred i a cryopreserved state to the requesting health care institution.
  • at least a portion of a preserved umbilical cord segment is receive from a storage facility upon following the procedure set forth above.
  • a biological sample or component is then isolated from ihe umbilical cord segment and is used to treat the patient.
  • Th umbilical cord segment is warmed prior to the isolation or extraction of the desired molecule, cell, tissue or organ por ⁇ tion.
  • the isolated or extracted component takes the form, for example, of a stem cell from the umbilical cord blood
  • the cell is then infused into the body of the patient with other st cells and possibly progenitor cells from the same umbilical cor segment and from other umbilical cord : segments whose specific unbilification parameters match the umbilification parameters determined for the patient.
  • Such an allogeneic hematopoietic reconstitution can be implemented after the preservation, umbilityping and storage of several millions of umbilical cord segments.
  • the stem cells from one matched umbilical cord segment are replicated in vitro and subsequently injected into the patient.
  • a method for replicating bone marro samples is described in U.S. Patent No. 4,721,096 to Naughton e al. , pertinent portions of which are hereby incorporated by reference herein.
  • the bone marrow sample is obtained from a bone or bones of a donor.
  • Pursuant to the inve tion bone marrow cells (stem cells, progenitor cells) are obtained from one or more preserved umbilical cord segments.
  • an autologous hematopoietic reconstitution can b effectuated upon in vitro replication of stem cells obtained fr a preserved specimen of the patient's own umbilical cord.
  • any hematopoietic reconstitution technique involving replication of the required cells only a small segment of a single umbilical cord is needed.
  • a program of storing umbilical cord segments for all individuals born after a prescribed date within a predetermined geographical area provides a bank or repository of human molecular, cellular, tissue and organic com ponents for research and therapeutic purposes.
  • This repository shall become increasingly valuable as more techniques are developed for isolation and use of various umbilical cord com ⁇ ponents.
  • a store of biological and personal histo information is provided for use with the preserved umbilical co segments.
  • Umbilification technology in accordance with the pres ent invention shall provide a repository of raw material for research into diseases affecting entire groups of people, for example, sickle-cell anemia or Tay-Sachs disease.
  • This technol ogy will also enable the tracing of changes in genetic composi ⁇ tions of families giving rise to a predisposition to such afflications as cancer.
  • changes in genetic make-u due, for example, to radioactive fall-out from a nuclear catastrophe or accident can be traced from umbilical cord seg ⁇ ments and associated information for all the people born in the area of the accident.
  • the bank or repository of huma molecular, cellular, tissue and organic components for research and therapeutic purposes is built from material (umbilical cord segments) which could otherwise be discarded after the infants' births.
  • the bank or repository is thus implemented without any invasive surgery or other invasive extraction techniques.
  • a method in which umbilical cord sections are cryopreserved in accordance with the present invention would ha v.tility even if the various cells in the umbilical cord, includ ing blood cells and endothelial vein cells, were not found in a particular instance to be viable in sufficient numbers. It is known that DNA may be cryopreserved for a significant period. mentioned above, Vivigen, Inc., a company in Santa Fe, New Mexico, has announced its readiness to cryogenically store DNA and RNA for medical and research purposes.
  • the DNA and/or RNA in a cryopreserved umbilical cord section may be used to identify or confirm the identity of an individual who is, for example, unconscious from an accident or a disease or who refuses to provide proof of his identity.
  • the comparative analysis of the individual's genetic material with the genetic material of an umbilical cord section performe by known techniques, such as those disclosed in U.S. Patents Nos 4,772,549 and 4,861,708 to Philippe M. Frossard, the disclosures of which are incorporated by reference herein, may be supple ⁇ mented by blood typing and other histological, cellular and molecular assay techniques.
  • a preserved umbilical cord segment is received from a storage facility, while information recorded at the birth of an infant attached to an umbilical cord from which said umbilical cord seg ment was severed and subsequently preserved is also received.
  • the recorded information includes statistics pertaining to the newborn and his or her birth, together with an identification of the preserved umbilical cord segment.
  • biological material of a type to be found in umbilical cords is isolated and extracted from an individual to be identified and analyzed t determine a plurality of predetermined umbilification parameters The determined values of the predetermined parameters are then compared with the received information to determine whether the individual to be identified is the same person as the infant fro which the preserved umbilical cord was obtained.
  • the parameters used for the identification process may include blood type and composition of genetic materials.
  • the step of isolating includes the steps of separating out and determining the composi tion of genetic material from cells of the idividual to be identified, the step of comparing including the comparison of that separated-out genetic material with material from cellular bodies in an frozen umbilical cord segment.
  • the preserved umbilical cord segments may be taken out of storage an analyzed by the new techniques.
  • those values, properly encoded are stored in a computer togethe with the personal history and other information recorded at the birth of the respective individual from which the umbilical cord segment was severed and subsequently preserved.
  • the personal history information includes statistics pertaining to the individual and the individual's birth, together with an identification of the preserved umbilical cord segment.

Abstract

A method for use in preparing a biological sample, ultimately for such purposes as individual identification, research or therapeutic treatment, comprises the steps of (a) upon the birth of an infant, obtaining a segment of the infant's severed umbilical cord, (b) closing both ends of the segment, (c) preserving (e.g., by freezing) the sealed umbilical segment to preserve at least one biological component of the umbilical segment, (d) recording statistics pertaining to the individual and the individual's birth, together with an identification of the preserved umbilical segment, and (e) conveying the preserved umbilical segment to a storage facility. The umbilical cord segments are maintained in a long-term storage facility for an indefinite period. An associated method for confirming the identity of a person comprises the steps of (a) receiving at least a portion of a preserved umbilical cord segment from the storage facility, (b) isolating from the person biological material of a type to be found in umbilical cords and recuding the biological material to values of a plurality of predetermined parameters, and (c) comparing the determined values of the predetermined parameters with the received information to determine whether the person is the same as the individual.

Description

IDENTIFICATION PROCESS AND RELATED METHOD FOR USE IN PREPARING A BIOLOGICAL SAMPLE
Background of the Invention
This invention relates to a method for use in identifying a person and more particularly in medically identifying a person. This invention also relates to a method for preparing for use a biological sample, for ultimate use in an identification process, medical research, or a therapeutic treatment. The invention also relates to a method for therapeutically treating a patient. More particularly, the instant invention relates to utilization of the umbilical cord in identification, medical research and therapeutic techni¬ ques. These therapeutic techniques are specifically applica¬ ble in he atopoietic reconstitution and are implemented without the pain generally accompanying the aspiration of bone marrow from donors in transplantology procedures and without the dangers of the anesthesia used during the extraction process.
The human umbilical cord.reaches a length of 35 to 50 cm at term and includes two umbilical artieries and a single umbilical vein. The vein carries oxygenated blood from the placenta to the fetus. The arteries and the vein are embedded in a mucous connective tissue in turn covered by an epithelium which is multilayered at birth. The connective tissue includes interlacing bundles of collagen fibers having intercellular spaces filled with a gelatinous substance known as Wharton's jelly. The cells of the connective tissue are a primitive form of fibroblast, have easily detectable nucleii and are rich in collagen. The umbilical arteries have rela¬ tively thick muscular walls containing a diffuse network of elastic fibers.
In many instances, the umbilical cord, like the placenta, is discarded after birth. However, it has been dis¬ covered that at least certain constituents of the umbilical cord may have a special usefulness. In a recent advance in the treatment of bone marrow defects in infants, physicians used the blood cells from the umbilical cord of an infant to aid in the regeneration of the stem cells in an older sibling. The blood was separated from the umbilical cord, subsequently frozen, and stored for seven months prior to infusion. Upon thawing, the cells were intravenously infused into the body of the recipient youngster. This technique provides several advantages over conventional marrow transplantation. Using the cord blood in this instance enabled transplant as soon as a compatible sibling was born, while candidates for marrow transplant generally must wait until the newborn is at least six months old. In addition, the procedure eliminates for the donor the pain of marrow extraction.
Other uses for constitutents of the human umbilical cord have been instated. For example, in the article "Dif¬ ferential Prostacyclin Production by Human Umbilical Vascula- ture" by John H. Harold et al.. Archive of Pathological Laboratory Medicine. Vol, 112, pp. 43-46 (January 1988), the authors point out that the human umbilical cord provides an easily accessible source of human vascular tissue.
Conventional methods for identifying or confirming the identities of people are based on such individual indicia as fingerprints and tooth morphology. Newer techniques involve voice prints and retinal structure. All of these con¬ ventional methods can provide information about who an indi¬ vidual is. "Umbilification" technology pursuant to the inven¬ tion as defined hereinafter can provide information as well as to the biological, histological, and biochemical constituants of a person.
Another recently developed identification technique is based on the composition of genetic material. U.S. Patents Nos. 4,772,549 and 4,861,708 to Philippe M. Frossard, for example, disclose methods for determining the genetic identity of an individual human subject. The former patent in particu¬ lar describes and claims a method comprising the steps of extracting DNA from the somatic cells of the human subject, digesting the extracted DNA with a selected restriction enzyme, and examining the digested DNA for polymorphisms from a preselected grouping, wherein the polymorphisms are defined by the presence or absence of a DNA fragment of known length which hybridizes to any one of several predetermined probes or their equivalents. Other methods for genetic typing and identification are known and have been sufficiently developed to enable a determination of parentage from comparison of a child's DNA material with that of possible fathers.
Cryogenic preservation techniques have advanced suf¬ ficiently to enable the long term .storage of genetic materials. Vivigen, Inc., a company in Santa Fe, New Mexico, has announced that it is commencing the cryogenic storage of DNA and RNA for medical and research purposes. This firm, along with other companies currently storing DNA are currently sotring diseased cells only. Objectives of the Invention
An object of the present invention is to provide a method for use in identification procedures.
Another object of the present invention is to pro¬ vide a method for obtaining medical identification information for individuals upon birth and, additionally, for medically identifying individuals at birth.
Another, more particular, object of the present invention is to provide such a method wherein the medical identification information is biological or biochemical in nature.
Another object of the present invention is to pro¬ vide a method for obtaining medical identification information and aiding in medical research and therapeutic treatment, by a nohinvasive procedure which is less painful than other meth¬ ods.
Yet another object of the present invention is to provide a method for obtaining medical identification informa¬ tion and aiding in medical research and therapeutic treatment tyhich is less expensive than other methods.
An additional object of the present invention is to provide a method for preparing for use a biological sample. The sample can be ultimately used in an identification process, medical research or a therapeutic treatment.
Yet another object of the present invention is to provide a method for therapeutically treating a patient.
Another, more particular, object of the present invention is to provide a method utilizing the umbilical cord in identification, medical research and therapeutic techni¬ ques.
Yet another particular object of the present inven¬ tion is to provide a method for use in typing the contents of the umbilical cord.
A further particular object of the present invention is to provide a method for gathering and storing the contents of umbilical cords in each typed category. Summary of the Invention
This invention pertains to the typing of the con¬ tents of umbilical cords ("umbilityping") and to using specific values of umbilical cord parameters ("umbilifica¬ tion") for medical identification and/or research information. Umbilification technology entails the preservation and storage of umbilical cords of the world's newborn population for pur¬ poses of identification and enhancement of their medical well being.
A method for preparing for use a biological sample, ultimately for such purposes as individual medical identifica¬ tion, research or therapeutic treatment of a patient, com¬ prises, in accordance with the present invention, the steps of (a) upon the birth of an infant, obtaining at least a segment of the infant's severed umbilical cord, (b) preserving at least a portion of the obtained umbilical segment, (c) record¬ ing statistics pertaining to the individual and the individ¬ ual's birth, together with an identification of the preserved umbilical segment, and (d) conveying the umbilical segment to a storage facility. The recorded statistics include, for example, the infant's name and weight and his or her genetic heritage, including genetic predispositions to certain dis¬ eases.
Pursuant to another feature of the present inven¬ tion, the step of preserving includes the step of closing opposite ends of the umbilical segment. The closing is preferably accomplished by tying off both ends of the segment. However, other techniques may be more advantageous, depending on the individual circumstances. The segment may be placed in a respective container or receptacle, such as a box, bag or ampule, which may carry on an external surface a bar code readable by a laser or other type scanner. If the umbilical cord segment is not stored in a respective container, the opposite ends of the severed segment may, for example, be cov¬ ered with respective end caps made of a material suitable for the use of a bar code and laser scanner.
Pursuant to another feature of the present inven¬ tion, the step of preserving may include the step of cooling the umbilical segment. Preferably, the umbilical segment is frozen and preserved cryogenically. In that event, the storage facility is a cryogenic storage facility. The preser¬ vation may be accomplished by immersion of the segments in a bath of liquid nitrogen or supercooled carbon dioxide, or by placing the segments in respective thin-walled containers and placing the containers in contact with a chlorofluorocarbon mixture.
It is to be noted that the invention contemplates utilization of the preservation technique best suited to mini¬ mize destruction of the cellular contents of the umbilical cord.
The umbilification storage facility can be centrally located and serve, for example, several hospitals all in the same city, county or state. In some instances, however, the storage facility may be a small unit, perhaps even portable, located on the hospital premises.
In accordance with another aspect of the present invention, the recorded statistics are transmitted to an information storage facility. Preferably, that storage facility is at the same location as the cryogenic storage apparatus.
In one possible embodiment of the invention, the personal history information is not transferred or stored. The stored umbilical cord segments may in that case neverthe¬ less be used for research wherein the identity of the infant is immaterial.
Pursuant to further features of the present inven¬ tion, the umbilical cord may be severed into a multiplicity of segments, each of the segments is closed at opposite ends thereof, for example, by tying or otherwise clamping, and then the closed or sealed segments are separately preserved, for example, by freezing. The segments may be of various sizes.
Thus, in a particular embodiment of the present invention, a method for preparing for use a biological sample, ultimately for such purposes as individual identi ication, research or therapeutic treatment, comprises the steps of (a) upon the birth of an infant, obtaining a segment of the infant's umbilical cord, (b) closing both ends of the segment in preparation for its preservation, (c) preserving (e.g., by freezing or freeze-drying) the segmented umbilical cord so that its biological components can be utilized for medical identification, research and/or therapeutic treatment of patients, and (d) recording statistics pertaining to the indi¬ vidual and the individual's birth, as well as pertinent family information, together with an identification of the preserved umbilical segment. The preserved umbilical segment is in most cases stored for possible future use of its biological, histological, cellular and biochemical components.
Preferably, a method in accordance with the present invention, including the steps of severing, closing, freezing, and recording, is performed for each individual infant born in a health care institution and preferably in an entire state or country. If a replication (e.g., in vitro replication) tech¬ nology is utilized, the preserved and stored umbilical cords can be of great medical benefit to the respective individuals. For example, with the utilization of a replication technology, autologous hematopoietic reconstitution can be effectuated in an adult patient, using umbilical cord blood cells stored in the preserved umbilical cord at the time the patient was an infant. As the numbers of stored umbilical cords increase and the typing of the umbilical cords into categories proceeds, the value of umbilification technology accordingly increases. Because of the vast numbers of umbilical cords stored then in each typed classification, allogeneic hematopoietic reconstitution may be implemented, without the utilization of replication technology.
With umbilical cords of twins, triplets, quad¬ ruplets, etc., umbilityped into categories, the stored materials can be retrieved and expanded and used in syngeneic transplants without a need for aspirating marrow from donating siblings. All of these procedures in hematopoietic reconstitution can be implemented without pain or with less pain than is currently experienced in transp1antology.
Embodiments of the instant invention contemplate the monitoring of incoming requests for preserved and stored materials. Upon a request for a stored cellular material, the identified umbilical cord segment can be retrieved from the storage apparatus and can be conveyed to the appropriate loca¬ tion.
In another method in accordance with the present invention, for use in individual identification, at least a portion of a preserved umbilical cord segment is received and treated to isolate a kind of biological material. The biological material is analyzed to determine values of a plurality of predetermined biochemical parameters. In another step, information recorded at the birth of an individual attached to an umbilical cord from which the umbilical cord segment was severed and subsequently preserved is received. The information includes statistics pertaining to the individ¬ ual and the individual's birth, together with an identifica¬ tion of the preserved umbilical cord segment. The received recorded information and the determined values of the predetermined biochemical parameters are then stored for future reference. The umbilical parameters for which specific values (the umbilitype) are determined may include, for exam¬ ple, blood type, tissue type or composition of genetic materials or any other materials contianed within the umbili- cai cord.
Pursuant to yet another feature of the present invention, the step of isolating includes the steps of separating out genetic material from cells of the person, the step of analyzing including the step of comparing the composi¬ tion of the separated genetic material with known genetic com¬ positions to determine at least in part a genetic structure of the individual.
A method for therapeutically treating a patient com¬ prises, in accordance with the present invention, the steps of (a) receiving at least a portion of a preserved umbilical cord segment from a storage facility, (b) isolating a biological component of the portion of the umbilical cord segment, and (c) using the isolated component to treat the patient.
The umbilical cord segment is preferably cryopreserved, the storage facility being a cryogenic storage facility. Then, a further step includes warming the portion of the umbilical cord segment.
Where the isolated umbilical segment component is a cell, the step of using the isolated component to treat the patient includes the step of infusing the cellular material into the patient. The cell may exemplarily take the form of a stem cell from the blood of the preserved umbilical cord seg¬ ment and is infused intraveously into a patient suffering from a blood or blood marrow disorder.
In accordance with a particularly feature of the present invention, prior to infusion into the patient, an appropriate isolated umbilical cord blood cell will have been replicated in vitro by others.
The preservation of umbilical cords in accordance with the present invention serves as a universal procedure for obtaining information for purposes of medical identification. In addition, as umbilical cord segments are stored in greater numbers and are typed for their tissue, cellular and biochemi¬ cal characteristics ("umbilityping") , a valuable bank is created which stores:
(1) blood cells, for example, stem cells and progenitor cells for hematopoietic reconstitution, both autologous and major histocompatibility complex-matched;
(2) human vascular tissue; and
(3) genetic information, not only for identi¬ fication purposes, but for-research and prolifera¬ tion extending over generations of individuals and across large geographical areas.
This bank of medical information and materials for therapeutic treatment is collected in a noninvasive manner without pain to the individual. Moreover, the information and biological materials are collected by a method which is less expensive than other methods, for example, extracting blood fro newborn babies, which requires a medical examination of the infant to determine whether it can safely withstand the extrac¬ tion procedure.
Pursuant to the invention, the individual umbilical cords are typed into categories. As the members of typed cel¬ lular material in each category increases, it will eventually b possible to utilize the accumulated cellular materials in each category for allogeneic hematopoietic reconstitution. This is important insofar as it permits therapeutic treatment of adults without the need for replication technology.
In contrast to existing or proposed repositories of genetic materials, a bank of biological, histological and biochemical materials formed in accordance with the present invention may include both diseased cells and healthy cells. Although the storage of healthy cells is the primary purpose an effect of the invention, on those occasions where diseasedcells are stored, the diseased cells may be useful for research pur¬ poses. In addition, in the event that the diseased cells are undesirable for any particular application, it is possible to cull out the diseased cells (e.g., leukemia cells) through the use of known magnetic, photochemical and/or chemical techniques. Detailed Description
In a general embodiment of a method in accordance wit the invention, umbilical cords from infants born within a pres¬ cribed territory (a city, county, state or an entire country) a sectioned, preserved and stored . Also stored is information pertaining to each individual such as the infant's name, birth statistics and any pertinent information as to genetic predisposition to certain diseases. The preserved umbilical cords or portions thereof are subsequently made available for medical identification, research purposes or therapeutic treat¬ ment upon proper request.
Specifically, upon the birth of an infant, its umbili¬ cal cord is severed into one or more segments. The severing may be, accomplished by any known technique. See, for example, U.S. Patent No. 4,648,401 to Philip D. Mattson, the disclosure of which is incorporated by reference herein.
Upon severing of an umbilical cord segment, the ends o the segment are closed to retain all biological materials ontained within the umbilical cord. The closure may be accomplished by tying or with synthetic resin end caps or other clamps, or otherwise sealed. The closure procedure is imple¬ mented on a free end of the umbilical cord segment while that e is clamped by a hemostat or other instrument. In an alternativ procedure, the ends of an umbilical cord are dipped into a cryogenic bath to close the ends by freezing.
The umbilical cord segments may be washed, preferably prior to sectioning of the cord to minimize the loss of umbilic cord blood. Alternatively, each segment may be washed subse¬ quently to the sealing of the ends.
Upon the sectioning of an umbilical cord and the clos ing of the segment ends, each segment is then preserved preferably by immersion in a cryogenic coolant such as liquifie nitrogen. Alternatively, a sealed umbilical cord section is first placed in a suitable thin walled container such as a polyethylene bag or vial. The container is then immersed in a low-temperature fluid. Such a fluid may take the form of liqui nitrogen, liquid carbon dioxide or a chlorofluorocarbon mixture such as those described in U.S. Patent No. 4,803,842 to Coehlo, the disclosure of which is incorporated by reference herein.
The umbilical cord segments may also be preserved by other techniques, such as freeze drying. Freeze-drying is generally not preferred because of the effects of the freeze- drying process on structures of various biological components such as cell membranes. However, inasmuch as certain biochemic components such as DNA, RNA and various proteins may be stored intact by a freeze-drying technique, preservation of at least o segment of each umbilical cord by freeze-drying may be useful.
A particular technique for preserving liposomes is di closed in published PCT Application No. PCT/US85/01502, Publica tion No. WO 86/01103. Liposome preparations are dehydrated und reduced pressure in the presence of one or more sugars, preferably the disaccharides trehalose and sucrose. The amount of the sugars used depends on the type of sugar and on the char acteristics of the liposomes to be protected. Freezing of the lipopsomes prior to dehydration is optional.
In an additional series of steps in a procedure in accordance with the invention, various constituten s, for exam¬ ple, blood and endothelial vein cells, of an umbilical cord are isolated from an umbilical -cord.sample at the birth of an infan The constituents are analyzed and typed according to known meth ods. For example, the blood type,, the blood protein concentra¬ tions, the karyotype, the H A and other factors are all determined and recorded. These umbilical cord parameters are included in the general statistical information pertaining to t personal history of the individual, including his or her name, parentage, birth date, weight, sex, etc., which is generally co lected by a health care institution such as a hospital.
Upon the umbilityping of the contents of the umbilica cord of a new-born infant, as described hereinabove, the umbilification information is transmitted, together with the pe sonal history statistics, to an information storage facility. The information is preferably encoded in digital form and is transmitted via a communications link (telephone, wireless, satellite) to the storage facility, which is preferably a genera purpose computer.
The computer is an information repository containing all the umbilification and personal history information for all individuals born after a certain date in the prescribed area (a hospital, a city, a county, several counties, a state, several states or an entire country) . The stored information includes, for each parcel of umbilification and personal history infor a- tion, the location of the individual's umbilical cord segment or segments.
Upon freezing of an umbilical cord segment, the segmen is conveyed to a cryogenic storage facility. Analogous to the information storage facility, the cryogenic storage facility is repository containing umbilical cord segments for all individual born after the prescribed date in the prescribed locale. The computer and the cryogenic storage facility may be in the same location, the computer serving in part to monitor and memorize the locations of the cryopreserved umbilical cord segments in th cryogenic storage facility. The cryogenic storage facility advantageously takes the form of the apparatus disclosed and claimed in copending U.S. Patent Application Serial No. 389,543 filed August 4, 1989 by Hermann Knippscheer and Daniel D. Richard, the disclosure of which is hereby incorporated by :reference. It is contemplated that several umbilical cord segment for each newborn individual are prepared and transferred to the cryogenic repository for future utilization under different cir¬ cumstances. As a precaution, it is recommended that one or more segments for each individual are sent to a second, back-up facility essentially duplicating the umbilical cord and informa¬ tion contents of the first cryogenic/information storage facility.
Umbilical cord segments are maintained in a cryopreserved or freeze-dried state at a cryogenic storage facility for an indefinite period. The facility receives requests for items stored at the facility. Upon receiving a request for a deposited stored umbilical cord segment, that seg¬ ment is retrieved from storage and conveyed at least in part to another location.
Several uses of consitutent parts of umbilical cords are already known. It is known, for example, that umbilical cor blood includes hematopoietic stem and multipotential (CFU-GEMM) , crythroid (BFU-E) , and granulocyte-macrophage (CFU-GM) progenito cells utilizable in hematopoietic reconsitution as an alternativ to bone marrow transplantation. See, e.g., "Human umbilical cor blood as a Potential Source of Transplantable Hematopoietic Stem/Progenitor Cells" by Hal E. Broxmeyer et al.. Proceedings. National Academy of Sciences, Vol. 86, pp. 3828-32 (1989), which is incorporated by reference herein, and references cited in the article. Broxmeyer et al. noted that umbilical cord blood con¬ tains numbers of CFU-GM cells well within the range of bone mar¬ row CFU-GM cells that have been associated with successful autologous and major histocompatibility complex-matched allogeni bone marrow transplantation. The conclusion to be drawn from that study is that cells from human umbilical cord blood from a single individual are sufficient for autologous reconstitution and for major histocompatibility complex-matched allogenic hematopoietic reconstitution.
In a recent clinical study described in the article, incorporated by reference herein, "Hematopoietic Reconstitution __n a Patient With Fanconi's Anemia by Means of umbilical cord blood From an HLA-Identical Sibling," by Elaine Gluckman et al., New England Journal of Medicine, Vol. 321, No. 17, pp. 1174-78 (•Oct. 26, 1989) , a five year-old boy having classic symptoms an malformations of Fanconi's anemia received cryopreserved umbili cal cord blood, isolated from the umbilical cord prior to freez ing, from a sister shown to be unaffected by the disorder, to have a normal karyotype, and to be HLA-identical to the patient. After a pretreatment including the.oral administration nonabsor bable antibiotics and of cyclophosphamide for pretransplantatio conditioning and further including the application of irradiati to the thoracoabdominal region by a linear accelerator, cryopreserved umbilical cord blood was thawed and infused into the patient without further processing. The blood had been obtained from the sister's umbilical cord and the placenta and transported at ambient temperature by overnight courier to a laboratory for analysis, cryopreservation and storage. The bloo was frozen in dimethyl sulfide at a final concentration of 10 percent. Upon thawing of the umbilical cord blood, it was found that eighty-two percent of the nucleated cells were viable. As suggested by the Gluckman et al. article, other conditions for which bone marrow transplant is indicated may be treated with th use of cord blood.
Accordingly, blood from cyropreserved umbilical cord segments may be used, in accordance with the invention, in bone marrow reconstitution. Upon a blood typing of the patient, in hich specific values of umbilityping parameters are determined for that individual, the determined umbilification information i transmitted to the information repository, where it is compared with the digitally stored blood type and other information pertinent to stored umbilical cord segments. Upon detecting a match, the corresponding umbilical cord segment is transferred i a cryopreserved state to the requesting health care institution. In a method for therapeutically treating a patient, at least a portion of a preserved umbilical cord segment is receive from a storage facility upon following the procedure set forth above. A biological sample or component is then isolated from ihe umbilical cord segment and is used to treat the patient. Th umbilical cord segment is warmed prior to the isolation or extraction of the desired molecule, cell, tissue or organ por¬ tion.
If the isolated or extracted component takes the form, for example, of a stem cell from the umbilical cord blood, the cell is then infused into the body of the patient with other st cells and possibly progenitor cells from the same umbilical cor segment and from other umbilical cord :segments whose specific unbilification parameters match the umbilification parameters determined for the patient. Such an allogeneic hematopoietic reconstitution can be implemented after the preservation, umbilityping and storage of several millions of umbilical cord segments.
In an alternative procedure for an allogeneic hematopoietic reconstitution, the stem cells from one matched umbilical cord segment are replicated in vitro and subsequently injected into the patient. A method for replicating bone marro samples is described in U.S. Patent No. 4,721,096 to Naughton e al. , pertinent portions of which are hereby incorporated by reference herein. In that patent, the bone marrow sample is obtained from a bone or bones of a donor. Pursuant to the inve tion, bone marrow cells (stem cells, progenitor cells) are obtained from one or more preserved umbilical cord segments.
It is also within the contemplation of the instant invention that an autologous hematopoietic reconstitution can b effectuated upon in vitro replication of stem cells obtained fr a preserved specimen of the patient's own umbilical cord. Of course, in any hematopoietic reconstitution technique involving replication of the required cells, only a small segment of a single umbilical cord is needed.
It is to be noted that a program of storing umbilical cord segments for all individuals born after a prescribed date within a predetermined geographical area provides a bank or repository of human molecular, cellular, tissue and organic com ponents for research and therapeutic purposes. This repository shall become increasingly valuable as more techniques are developed for isolation and use of various umbilical cord com¬ ponents. In addition, a store of biological and personal histo information is provided for use with the preserved umbilical co segments.
Umbilification technology in accordance with the pres ent invention shall provide a repository of raw material for research into diseases affecting entire groups of people, for example, sickle-cell anemia or Tay-Sachs disease. This technol ogy will also enable the tracing of changes in genetic composi¬ tions of families giving rise to a predisposition to such afflications as cancer. In addition, changes in genetic make-u due, for example, to radioactive fall-out from a nuclear catastrophe or accident can be traced from umbilical cord seg¬ ments and associated information for all the people born in the area of the accident.
It is to be noted that the bank or repository of huma molecular, cellular, tissue and organic components for research and therapeutic purposes is built from material (umbilical cord segments) which could otherwise be discarded after the infants' births. The bank or repository is thus implemented without any invasive surgery or other invasive extraction techniques.
^ * * . A method in which umbilical cord sections are cryopreserved in accordance with the present invention would ha v.tility even if the various cells in the umbilical cord, includ ing blood cells and endothelial vein cells, were not found in a particular instance to be viable in sufficient numbers. It is known that DNA may be cryopreserved for a significant period. mentioned above, Vivigen, Inc., a company in Santa Fe, New Mexico, has announced its readiness to cryogenically store DNA and RNA for medical and research purposes. Pursuant to the pres ent invention, the DNA and/or RNA in a cryopreserved umbilical cord section may be used to identify or confirm the identity of an individual who is, for example, unconscious from an accident or a disease or who refuses to provide proof of his identity. The comparative analysis of the individual's genetic material with the genetic material of an umbilical cord section, performe by known techniques, such as those disclosed in U.S. Patents Nos 4,772,549 and 4,861,708 to Philippe M. Frossard, the disclosures of which are incorporated by reference herein, may be supple¬ mented by blood typing and other histological, cellular and molecular assay techniques.
Accordingly, in a method for identifying a person, a preserved umbilical cord segment is received from a storage facility, while information recorded at the birth of an infant attached to an umbilical cord from which said umbilical cord seg ment was severed and subsequently preserved is also received. The recorded information includes statistics pertaining to the newborn and his or her birth, together with an identification of the preserved umbilical cord segment. In a further step, biological material of a type to be found in umbilical cords (genetic material, blood including stem cells, etc.) is isolated and extracted from an individual to be identified and analyzed t determine a plurality of predetermined umbilification parameters The determined values of the predetermined parameters are then compared with the received information to determine whether the individual to be identified is the same person as the infant fro which the preserved umbilical cord was obtained. As described hereinabove, the parameters used for the identification process may include blood type and composition of genetic materials. More specifically, in the latter instance, the step of isolating includes the steps of separating out and determining the composi tion of genetic material from cells of the idividual to be identified, the step of comparing including the comparison of that separated-out genetic material with material from cellular bodies in an frozen umbilical cord segment. This method is essentially set forth in the aforementioned U.S. Patents Nόs. 4,772,549 and 4,861,708 to Philippe M. Frossard.
It is contemplated in accordance with the preseni. invention that as further techniques become developed and known techniques perfected for isolating, identifying and replicating molecular, cellular and other components of umbilical cords, the preserved umbilical cord segments may be taken out of storage an analyzed by the new techniques. Upon determination of the value of a plurality of such biochemical or histological parameters, those values, properly encoded, are stored in a computer togethe with the personal history and other information recorded at the birth of the respective individual from which the umbilical cord segment was severed and subsequently preserved. As stated above the personal history information includes statistics pertaining to the individual and the individual's birth, together with an identification of the preserved umbilical cord segment.
Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill i the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingl it is to be understood that the drawings and descriptions herei are proferred by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims

CLAIMS:
1. A method for use in preparing a biological sample, comprising the steps of: upon the birth of an individual, obtaining a segment a severed umbilical cord which extended from said individual to respective placenta; closing both ends of said segment; freezing the umbilical segment to preserve at least o biological component of the umbilical segment; recording statistics pertaining to said individual an said individual's birth, together with an identification of the umbilical segment; and conveying the umbilical segment to a cryogenic storag facility.
2. The method recited in claim 1 wherein said step of closing is performed prior to said step of freezing.
3. The method recited in claim 1 wherein said step of conveying is performed subsequently to said step of freezing.
4. The method recited in claim 1, further comprising the step of transmitting the recorded statistics to an informa¬ tion storage facility.
5. The method recited in claim 4 wherein said cryogen storage facility and said information storage facility are at t same location.
6. The method recited in claim 1 wherein said steps o obtaining, closing, freezing, recording and conveying are per¬ formed for each individual infant born in a health care institu tion.
7. The method recited in claim 1, further comprising the steps of severing the umbilical cord segment into a multi¬ plicity of sections, closing each of said sections at opposite ends thereof and freezing all of the closed segments.
8. The method recited in claim 7, further comprising the step of conveying at least two of the umbilical sections t separate cryogenic storage facilities.
9. The method recited in claim 8, further comprising the step of transmitting the.recorded statistics, necessarily pertaining to all of the umbilical sections, to two separate information storage facilities.
10. A method for use in preparing a biological sample for a therapeutic treatment, comprising the steps of: providing a preserved umbilical cord segment closed a opposite ends; depositing the preserved umbilical cord segment in a long-term storage apparatus; maintaining the deposited umbilical cord segment in a preserved state in said storage apparatus for an indefinite period; receiving incoming requests for materials stored in said storage apparatus; upon receiving a request for a biological component o the deposited umbilical cord segment, retrieving the deposited umbilical cord segment from said storage apparatus; and conveying at least a portion of the deposited umbilic cord segment to another location.
11. The method recited in claim 10, further comprisin the step of recording the location of the deposited umbilical cord segment in said storage apparatus.
12. A method for identifying or confirming the identi of a person, comprising the steps of: receiving at least a portion of a preserved umbilical cord segment from a storage facility; isolating from said person biological material of a type to be found in umbilical cords and reducing said biologica material to values of a plurality of predetermined parameters; and comparing the determined values of said predetermined parameters with the received information to determine whether said person is the same as said individual.
13. The method recited in claim 12, further comprisin the step of receiving information recorded at the birth of an individual attached to an umbilical cord from which said umbili cal cord segment was severed and subsequently preserved, said information including statistics pertaining to said individual and said individual's birth, together with an identification of the preserved umbilical cord segment.
14. The method recited in claim 12 wherein said para¬ meters include blood type.
15. The method recited in claim 12 wherein said para¬ meters include composition of genetic materials.
16. The method recited in claim 12 wherein said step isolating includes the steps of separating out and analyzing genetic material from cells of said person, said step of compar ing including the comparison of said genetic material with material from cellular bodies in said frozen umbilical cord seg ment.
17. The method recited in claim 12 wherein said umbil cal cord segment is preserved by cooling.
18. The method recited in claim 12 wherein said umbil cal cord segment is preserved by freezing.
19. A method for use in identification, comprising th steps of: receiving at least a portion of a preserved umbilical cord segment; isolating from said portion of said preserved umbilic cord segment biological material; analyzing said biological material to determine value of a plurality of predetermined biochemical or histological par meters; receiving information recorded at the birth of an in vidual attached to an umbilical cord from which said umbilical cord segment was severed and subsequently preserved, said information including statistics pertaining to said individual and said individual's birth, together with an identification of the preserved umbilical cord segment; and storing the received recorded information and the determined values of said predetermined biochemical or histolog cal parameters.
20. The method recited in claim 19 wherein said para¬ meters include blood type.
21. The method recited in claim 19 wherein said para¬ meters include composition of genetic material.
22. The method recited in claim 19 wherein said step isolating includes the steps of separating out genetic material from cells of said person, said step of analyzing including the step of comparing said genetic material with known genetic com¬ positions to determine at least in part a genetic structure of said individual.
23. A method for therapeutically treating a patient, comprising the steps of: receiving at least a portion of a preserved umbilical cord segment from a storage facility; isolating a biological or biochemical component of sa portion of said umbilical cord segment; and using the isolated component to treat the patient.
24. The method recited in claim 23 wherein said porti of said umbilical cord segment is frozen and said storage facility is a cryogenic storage facility, further comprising th step of warming said portion of said umbilical cord segment.
25. The method recited in claim 23 wherein said com¬ ponent is a cell, said step of using the isolated component to treat the patient including the step of infusing said cell into the patient.
26. The method recited in claim 25 wherein said cell a blood cell and is infused intraveously into the patient.
27. The method recited in claim 26 wherein said. step using the isolated component to treat the patient includes the steps of replicating said cell and infusing the replicated cell into the patient.
28. The method recited in claim 27 wherein the infusi comprises an autologous hematopoietic reconstitution.
29. The method recited in claim 27 wherein the infusi comprises an allogeneic hematopoietic reconstitution.
30. The method recited in claim 24, further comprisin the steps of isolating blood cells from several umbilical cord segments from said storage facility, said umbilical cord segmen all having a common umbilitype, and infusing said blood cells into the patient.
31. The method recited in claim 30 wherein the infusi comprises an allogeneic hematopoietic reconstitution.
32. The method recited in claim 23 wherein said step isolating is performed subsequently to said step of warming.
33. A method for use in preparing a biological sample comprising the steps of: upon the birth of an individual, obtaining a segment a severed umbilical cord wliich extended from said individual to respective placenta; preserving the umbilical segment; recording statistics pertaining to said individual an said individual's birth, together with an identification of the umbilical segment; and conveying the umbilical segment to a storage facility
34. The method recited in claim 33 wherein said step preserving is performed prior to.said -step of conveying.
35. The method recited in claim 33 wherein said step preserving includes the step of closing opposite ends of said umbilical segment.
36. The method recited in claim 35 wherein said step closing includes the step of tying off both ends of said segme
37. The method recited in claim 35 wherein said step closing includes the step of covering said ends of said segmen with respective caps.
38. The method recited in claim 33 wherein said step preserving includes the step of cooling said umbilical segment.
39. The method recited in claim 38 wherein said step cooling includes the step of freezing said umbilical segment.
40. The method recited in claim 39 wherein said stora facility is a cryogenic storage facility.
41. The method recited in claim 38 wherein said step cooling includes the step of freeze-drying said umbilical seg¬ ment.
42. The method recited in claim 33, further comprisin the step of storing said uπibilical segment.
43. The method recited in claim 42, further comprisin the steps of maintaining the stored umbilical cord segment in a preserved state in said storage facility for an indefinite period; receiving incoming requests for materials stored in said storage facility; upon receiving a request for a biological component o the deposited umbilical cord segment, retrieving the deposited umbilical cord segment from said storage apparatus.
44. The method recited in claim 33, further comprisin the step of transmitting the recorded statistics to an informa¬ tion storage facility.
45. The method recited .in claim 44 wherein the storag facility for said umbilical segment and said information storag facility are at the same location.
46. The method recited in claim 33 wherein said steps of obtaining, preserving, recording and conveying are performed for each individual infant born in a health care institution.
47. The method recited in claim 33, further comprisin the steps of severing said umbilical segment into a multiplicit of sections, closing each of said sections at opposite ends thereof and cooling all of the closed segments.
48. The method recited in claim 47, further comprisin the step of conveying at least two of the cooled umbilical seg¬ ments to separate storage facilities.
49. The method recited in claim 48, further comprisin the step of transmitting the recorded statistics, necessarily pertaining to all of the cooled umbilical segments, to at least two separate information storage facilities.
PCT/US1990/007583 1989-12-22 1990-12-20 Identification process and related method for use in preparing a biological sample WO1991009521A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US45517089A 1989-12-22 1989-12-22
US455,170 1989-12-22

Publications (1)

Publication Number Publication Date
WO1991009521A1 true WO1991009521A1 (en) 1991-07-11

Family

ID=23807677

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1990/007583 WO1991009521A1 (en) 1989-12-22 1990-12-20 Identification process and related method for use in preparing a biological sample

Country Status (3)

Country Link
AU (1) AU7166591A (en)
IE (1) IE902301A1 (en)
WO (1) WO1991009521A1 (en)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996026402A1 (en) 1995-02-23 1996-08-29 Thermogenesis Corporation Cryogenic storage of thermolabile products
WO1998058216A1 (en) 1997-06-16 1998-12-23 Thermogenesis Corp. Method for cryogenic storage of thermolabile materials
US5919176A (en) * 1996-05-14 1999-07-06 Children's Hospital Medical Center Of Northern California Apparatus and method for collecting blood from an umbilical cord
WO2001070023A1 (en) * 2000-02-25 2001-09-27 Jan Jaap Nietfeld Method for anonymously registering, storing and using body material and/or information derived therefrom
US6302327B1 (en) 1997-06-16 2001-10-16 Thermogenesis, Corp. Method and apparatus for cryogenic storage of thermolabile products
WO2007071048A1 (en) 2005-12-22 2007-06-28 Jane Ennis Viable cells from frozen umbilical cord tissue
US7328110B2 (en) 2001-04-10 2008-02-05 Biotech Holding B.V. System for cellular storage and genetic information retrieval
US8157774B1 (en) 2006-03-16 2012-04-17 Deka Products Limited Partnership Apparatus for stem cell collection and methods thereof
US8642255B2 (en) 2008-03-27 2014-02-04 Biolife Solutions, Inc. Materials and methods for hypothermic collection of whole blood
US8900573B2 (en) 2006-05-05 2014-12-02 John E. Davies Immune privileged and modulatory progenitor cells

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4108849A (en) * 1974-02-25 1978-08-22 Andre Thomas Process for extracting and processing glycoproteins, mucopolysaccharides and accompanying substances
US4423036A (en) * 1981-08-03 1983-12-27 Research Corporation Acid soluble platelet aggregating material isolated from human umbilical cord
US4803842A (en) * 1987-02-09 1989-02-14 Castleton, Inc. Direct contact cooling of foodstuffs with halocarbon heat transfer liquids
US4965185A (en) * 1988-06-22 1990-10-23 Grischenko Valentin I Method for low-temperature preservation of embryos

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4108849A (en) * 1974-02-25 1978-08-22 Andre Thomas Process for extracting and processing glycoproteins, mucopolysaccharides and accompanying substances
US4423036A (en) * 1981-08-03 1983-12-27 Research Corporation Acid soluble platelet aggregating material isolated from human umbilical cord
US4803842A (en) * 1987-02-09 1989-02-14 Castleton, Inc. Direct contact cooling of foodstuffs with halocarbon heat transfer liquids
US4965185A (en) * 1988-06-22 1990-10-23 Grischenko Valentin I Method for low-temperature preservation of embryos

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
NUCLEIC ACIDS RESEARCH, Vol. 16, No. 23, issued 1988, JEFFREYS et al., "Amplification of Human Minisatellites by the Polymerase Chain Reaction: towards DNA fingerprinting of Single Cells", see the entire paper, pages 10953-10971. *
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, (USA), Vol. 86, issued May 1989, BROXMEYER et al., "Human Umbilical Cord Blood as a Potential Source of Transplantable Hematopoietic Stem/Progenitor Cells", pages 3828-3832. *

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5964095A (en) * 1995-02-23 1999-10-12 Thermogenesis Corp. Method and apparatus for cryogenic storage of thermolabile products
US5638686A (en) * 1995-02-23 1997-06-17 Thermogenesis Corporation Method and apparatus for cryogenic storage of thermolabile products
WO1996026402A1 (en) 1995-02-23 1996-08-29 Thermogenesis Corporation Cryogenic storage of thermolabile products
US6190368B1 (en) 1996-05-14 2001-02-20 Children's Hospital Medical Center Of Northern California Apparatus and method for collecting blood from an umbilical cord
US5919176A (en) * 1996-05-14 1999-07-06 Children's Hospital Medical Center Of Northern California Apparatus and method for collecting blood from an umbilical cord
US5993429A (en) * 1996-05-14 1999-11-30 Childen's Hospital Medical Center Of Northern California Apparatus and method for collecting blood from an umbilical cord
US6440110B2 (en) 1996-05-14 2002-08-27 Children's Hospital Medical Center Of Northern California Apparatus and method for collecting blood from an umbilical cord
US6302327B1 (en) 1997-06-16 2001-10-16 Thermogenesis, Corp. Method and apparatus for cryogenic storage of thermolabile products
WO1998058216A1 (en) 1997-06-16 1998-12-23 Thermogenesis Corp. Method for cryogenic storage of thermolabile materials
WO2001070023A1 (en) * 2000-02-25 2001-09-27 Jan Jaap Nietfeld Method for anonymously registering, storing and using body material and/or information derived therefrom
US7706983B2 (en) 2000-02-25 2010-04-27 Intresco B.V. Method for anonymously registering, storing and using body material and/or information derived therefrom
AU2002309178B2 (en) * 2001-04-10 2008-12-04 Biotech Holding, B.V. System for cellular storage and genetic information retrieval
US7328110B2 (en) 2001-04-10 2008-02-05 Biotech Holding B.V. System for cellular storage and genetic information retrieval
WO2007071048A1 (en) 2005-12-22 2007-06-28 Jane Ennis Viable cells from frozen umbilical cord tissue
EP1976980A1 (en) * 2005-12-22 2008-10-08 Jane Ennis Viable cells from frozen umbilical cord tissue
EP1976980A4 (en) * 2005-12-22 2012-04-18 Jane Ennis Viable cells from frozen umbilical cord tissue
US8278102B2 (en) 2005-12-22 2012-10-02 Jane Ennis Viable cells from frozen umbilical cord tissue
US8790923B2 (en) 2005-12-22 2014-07-29 Jane E. Ennis Viable cells from frozen umbilical cord tissue
KR101507172B1 (en) 2005-12-22 2015-03-31 제인 에니스 Viable cells from frozen umbilical cord tissue
US8157774B1 (en) 2006-03-16 2012-04-17 Deka Products Limited Partnership Apparatus for stem cell collection and methods thereof
US8900573B2 (en) 2006-05-05 2014-12-02 John E. Davies Immune privileged and modulatory progenitor cells
US8642255B2 (en) 2008-03-27 2014-02-04 Biolife Solutions, Inc. Materials and methods for hypothermic collection of whole blood

Also Published As

Publication number Publication date
AU7166591A (en) 1991-07-24
IE902301A1 (en) 1991-07-03

Similar Documents

Publication Publication Date Title
US5125240A (en) Storage apparatus, particularly with automatic insertion and retrieval
KR100779812B1 (en) Preservation of non embryonic cells from non hematopoietic tissues
US5022236A (en) Storage apparatus, particularly with automatic insertion and retrieval
JP2005502712A5 (en)
WO1991009521A1 (en) Identification process and related method for use in preparing a biological sample
DE69634982D1 (en) PROCESS FOR INCREASING HEMATOPOIETIC CELLS
CN109479871A (en) Frozen stock solution, preparation method, application and China's Tong Shi glue tissue cryopreservation methods
Armiger et al. Morphology of heart valves preserved by liquid nitrogen freezing.
CN101717751A (en) Method for constructing banks of stem cells from human periodontal ligament
Stromberg et al. Development of larvae of Ascaris suum from the third to the fourth stage in a chemically defined medium
Stirling et al. Cells in the circulating blood capable of producing connective tissue
Gonzalez-Ryan et al. Umbilical cord blood banking: procedural and ethical concerns for this new birth option
Guilfoil et al. An unusual vascular complication of fractured clavicle
Malinin Processing and storage of viable human tissues
RU2160112C1 (en) Method for producing cellular transplant from fetus tissues
CN107412265B (en) The method for treating senium praecox or early ageing disease
Bertolini et al. Cord blood banking for stem cell transplant
EP1066833B1 (en) Use of cryopreserved activated lymphocytes as a medicament
Lavrishcheva et al. Transplantation of tissues preserved in formaldehyde solutions
BE1016380A6 (en) Cryogenic preservation of stem and progenitor cells in umbilical cord, used for treating e.g. disease, comprises freezing whole section of umbilical cord tissue
Burns et al. Freeze-etch studies of the granules of human mast cells and eosinophils
To et al. Guidelines for the collection, processing, storage and of administration of hemopoietic stem and progenitor cells for transplantation. Report of the Working Party on Hemopoietic Stem Cell Processing, Hematology Discipline Advisory Committee, the Royal College of Pathologists of Australasia
Man Tissue banking–a new hope for renerative medicine
Wiswedel Sperm banking at Groote Schuur Hospital
US20020100065A1 (en) Production of typed human cells, tissues and organs

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AU BR CA JP NO SU

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FR GB GR IT LU NL SE

NENP Non-entry into the national phase

Ref country code: CA