WO2013172724A1 - Method for treating obesity and overweight and gastro-oesophageal reflux disease - Google Patents

Method for treating obesity and overweight and gastro-oesophageal reflux disease Download PDF

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Publication number
WO2013172724A1
WO2013172724A1 PCT/PL2013/000063 PL2013000063W WO2013172724A1 WO 2013172724 A1 WO2013172724 A1 WO 2013172724A1 PL 2013000063 W PL2013000063 W PL 2013000063W WO 2013172724 A1 WO2013172724 A1 WO 2013172724A1
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WIPO (PCT)
Prior art keywords
adrc
cells
gastro
gastric
regenerative cells
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PCT/PL2013/000063
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French (fr)
Inventor
Zbigniew Kowalczyk
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Zbigniew Kowalczyk
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Publication of WO2013172724A1 publication Critical patent/WO2013172724A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/28Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells

Definitions

  • the present invention relates to the method for treating obesity and overweight and gastro-oesophageal reflux disease (GERD).
  • GSD gastro-oesophageal reflux disease
  • Obesity and overweight are the major problems of the modern world due to the increasingly wide occurrence and its social consequences.
  • Treatment of obesity and overweight includes usually a reduction of food intake (calories), and the increase of using and burning of stored fat.
  • Conservative methods rely on the introduction of different diets and restrictions and lifestyle changes by increasing physical activity and regular eating. Sometimes these methods are associated with the intake of drugs or widely available slimming products.
  • stomach capacity There are known and used surgical methods for reducing stomach capacity, such as: adjustable gastric band, gastric sleeve resection, duplications of the stomach wall from the outside or endoscopically (POSE, ROSE), Vertical Banded Gastroplasty or diversion- bypass procedures such as gastric bypass.
  • Adjustd stomach creates a feeling of fullness occurring earlier than before the surgery.
  • Gastric reduction is also carried out by implantation of intragastric balloons filling the part of the space inside the stomach to reduce its volume.
  • Surgical methods are subject to considerable risk and the possibility of complications, hence can only be used in certain cases, considering the condition of the patient and the risks arising from obesity-related diseases. Important are appropriate qualifications and experience of the surgical center.
  • Another method, known as the Full Sense Device is the introduction of prosthetic mesh in the area of over gastric cardia and fundus.
  • patent US2010/0160995 discloses the method of modeling surrounding the gastric cardia, which consists of injecting a biocompatible material in the area of gastric cardia - injected is hyaluronic acid or another resorbable or non-resorbable formulation.
  • a biocompatible material in the area of gastric cardia - injected is hyaluronic acid or another resorbable or non-resorbable formulation.
  • gastro-oesophageal reflux disease Obese or overweight people often have so called gastro-oesophageal reflux disease.
  • a method for preventing gastro-oesophageal reflux disease is reduced to taking the appropriate medications to minimize the discomfort.
  • the method for treating obesity and overweight and gastro-oesophageal reflux disease lies in the fact that the stem and regenerative cells extracted from adipose tissue (ADRC - Adipose Derived Regenerative Cells) are injected into the submucosa tissue or muscle near the gastric cardia and fundus.
  • ADRC Adipose Derived Regenerative Cells
  • the isolated ADRC cells are given via endoscopy or surgical procedures, open or laparoscopic.
  • the isolated ADRC cells are enriched with fat graft in the amount of at least 5 ml and not more than 25 ml.
  • the method is complementary to other bariatric procedures reducing the size of the stomach - such as adjustable gastric band, gastric sleeve partial resection ,or filling the stomach - as intragastric implants, or affecting the motility or satiety induction by electrical stimulation (neurostimulators) .
  • the stem and regenerative cells isolated from its own adipose tissue are injected into the submucosa or muscle tissue around gastric cardia.
  • ADRC cell transfer begins to feel satiety after the adoption of a small amount of food, thus reduces food intake. It is also a combination of the two techniques treating overweight and obesity - the liposuction procedure widely used in the world and endoscopic ADRC cells transfer to the area of gastric cardia and fundus in order to enhance the response of the stomach and reduce food intake.
  • the method according to the invention used in the treatment of obese or overweight people will also prevent gastro-oesophageal reflux disease.
  • the method of obtaining and enriching ADRC cells from adipose tissue helps to produce relatively large amounts of ADRC and application of the method to almost every patient.
  • the method according to the invention can also be applied in the treatment of other diseases, such as oncology-reconstructive surgery, particularly with the mammary gland, the treatment of complications after radiotherapy and classic burns, reconstructive surgery, cosmetic and aesthetic surgery, treatment of non-healing wounds, diseases of urinary incontinence.
  • other diseases such as oncology-reconstructive surgery, particularly with the mammary gland, the treatment of complications after radiotherapy and classic burns, reconstructive surgery, cosmetic and aesthetic surgery, treatment of non-healing wounds, diseases of urinary incontinence.
  • Autologous transfer process consists of three steps.
  • fat is removed from the patient body from the place indicated by the doctor.
  • Removing is technically identical to the liposuction surgery, which involves using a special cannulas to take from under the patient's skin excess of body fat. This is done by mechanical or vacuum-assisted method, ultrasound, laser and special fluids.
  • the second stage is carried out as stepwise treatment / processing of adipose tissue using a special device or laboratory methods.
  • This step involves exposing a standardized treatment of adipose tissue collected from the patient.
  • adipose tissue is repeatedly washed in order to remove erythrocytes, the excess of saline, substances used in liposuction and other polluting tissue.
  • the resulting substrate is subjected to enzymatic treatment with the method using a special enzyme.
  • the final step of this stage is the concentration of substrate in order to obtain a cell suspension containing the stem cells and regenerative cells (ADRC) by centrifugation with the alternate washing of the substrate.
  • the result of these steps is to obtain a homogeneous deposit of stem cells and regenerative ADRC cells directly applicable in surgical procedures.
  • autologous transplant in which to the submucosa tissue or muscle in the area of the gastric cardia and fundus, are administered homogeneous mixture of ADRC with or without the addition of fat graft (purified adipose tissue).
  • Administering a mixture of stem and regenerative ADRC cells in the area of gastric cardia and the fundus area leads to induce a feeling of gastric fullness, neurohormonal induction of satiety response, improvement of the function of the lower esophageal sphincter and humoral actions of own fat.
  • Administration of a mixture of stem and regenerative ADRC cells in the area of the lower esophageal sphincter is carried out to regenerate and improve the functional activities of the area, thereby prevent gastro-oesophageal reflux.
  • ADRC cells Method of administration, place and number of cells in each case depends on the circumstances and the decision of the medical doctor. In case of a additional amount of ADRC cells, they may be placed in storage or subsequent use for example in the case of difficult to obtain from a patient in the future.

Abstract

The present invention relates to the method for treating obesity and overweight and gastro-oesophageal reflux disease (GERD). According to the invention the method for treating obesity and overweight and gastro-oesophageal reflux disease lies in the fact that the stem and regenerative cells extracted from adipose tissue (ADRC - Adipose Derived Regenerative Cells) are injected into the submucosa tissue or muscle near the gastric cardia and fundus. The isolated ADRC cells are given via endoscopy or surgical procedures, open or laparoscopic. The isolated ADRC cells are enriched with fat graft in the amount of at least 5 ml and not more than 25 ml. The method is complementary to other bariatric procedures reducing the size of the stomach - such as adjustable gastric band, gastric sleeve partial resection,or filling the stomach - as intragastric implants, or affecting the motility or satiety induction by electrical stimulation (neurostimulators). It is preferred when the method is applied while other surgical procedures to obese or overwieght patients. In the treatment of gastro-oesophageal reflux disease the stem and regenerative cells isolated from its own adipose tissue (ADRC - Adipose Derived Regenerative Cells) are injected into the submucosa or muscle tissue around gastric cardia.

Description

Method for treating obesity and overweight and gastro-oesophageal reflux disease
The present invention relates to the method for treating obesity and overweight and gastro-oesophageal reflux disease (GERD).
Obesity and overweight are the major problems of the modern world due to the increasingly wide occurrence and its social consequences.
On one hand, lowering the standard of life of patients with obesity, reducing their efficiency, on the other accompanying diseases resulting from excess body weight (degenerative joint disease, hypertension, diabetes, cardiovascular disease) and their serious complications determine the need to fight with excessive food intake.
Treatment of obesity and overweight includes usually a reduction of food intake (calories), and the increase of using and burning of stored fat. Conservative methods rely on the introduction of different diets and restrictions and lifestyle changes by increasing physical activity and regular eating. Sometimes these methods are associated with the intake of drugs or widely available slimming products. There are also physical methods of action on body fat to cause its elimination or reduction - by liposuction surgery or by the use of external physical factors and electrical stimulation devices as well as lymphatic massage, laser therapy, ultrasound current or cryogenic lipolysis.
If conservative methods fail to achieve the desired effect, there exist a bariatric treatment, leading to more or less invasive surgical or endoscopic techniques in order to reduce the possibility of food intake or reduce the absorption of eaten food.
There are known methods for treating obesity or overweight that lead to the induction and increase of feeling of fullness.
There are known and used surgical methods for reducing stomach capacity, such as: adjustable gastric band, gastric sleeve resection, duplications of the stomach wall from the outside or endoscopically (POSE, ROSE), Vertical Banded Gastroplasty or diversion- bypass procedures such as gastric bypass. Reduced stomach creates a feeling of fullness occurring earlier than before the surgery. Gastric reduction is also carried out by implantation of intragastric balloons filling the part of the space inside the stomach to reduce its volume.
Surgical methods are subject to considerable risk and the possibility of complications, hence can only be used in certain cases, considering the condition of the patient and the risks arising from obesity-related diseases. Important are appropriate qualifications and experience of the surgical center. Another method, known as the Full Sense Device is the introduction of prosthetic mesh in the area of over gastric cardia and fundus.
However, patent US2010/0160995 discloses the method of modeling surrounding the gastric cardia, which consists of injecting a biocompatible material in the area of gastric cardia - injected is hyaluronic acid or another resorbable or non-resorbable formulation. Thus obtained narrowing of the gastric cardia, as in the case of prosthetic mesh, reduces the amount of food taken by the obese person, which in turn leads to a reduction in body weight.
Obese or overweight people often have so called gastro-oesophageal reflux disease. A method for preventing gastro-oesophageal reflux disease is reduced to taking the appropriate medications to minimize the discomfort.
According to the invention the method for treating obesity and overweight and gastro-oesophageal reflux disease lies in the fact that the stem and regenerative cells extracted from adipose tissue (ADRC - Adipose Derived Regenerative Cells) are injected into the submucosa tissue or muscle near the gastric cardia and fundus.
The isolated ADRC cells are given via endoscopy or surgical procedures, open or laparoscopic.
The isolated ADRC cells are enriched with fat graft in the amount of at least 5 ml and not more than 25 ml.
The method is complementary to other bariatric procedures reducing the size of the stomach - such as adjustable gastric band, gastric sleeve partial resection ,or filling the stomach - as intragastric implants, or affecting the motility or satiety induction by electrical stimulation (neurostimulators) .
It is preferred when the method is applied while other surgical procedures to obese or overwieght patients.
In the treatment of gastro-oesophageal reflux disease the stem and regenerative cells isolated from its own adipose tissue (ADRC - Adipose Derived Regenerative Cells) are injected into the submucosa or muscle tissue around gastric cardia.
A person who had autologous (ie, back to the body of the person who had the fat removed previously) ADRC cell transfer according to the method of the invention, begins to feel satiety after the adoption of a small amount of food, thus reduces food intake. It is also a combination of the two techniques treating overweight and obesity - the liposuction procedure widely used in the world and endoscopic ADRC cells transfer to the area of gastric cardia and fundus in order to enhance the response of the stomach and reduce food intake. The method according to the invention used in the treatment of obese or overweight people, will also prevent gastro-oesophageal reflux disease. The method of obtaining and enriching ADRC cells from adipose tissue helps to produce relatively large amounts of ADRC and application of the method to almost every patient. An important innovation is the ease of the removal of the material necessary for the patient's treatment and the whole procedure. Removing the fat technically is no different from liposuction procedures. The use of autologous transplant instead of transplant "from a donor" substantially reduces the possibility of complications during treatment. It also greatly simplifies the legal aspects of transplantation.
From the point of view of the good of the patient it is an improvement in medical technology by reducing the possible complications of the treatment, a significant decrease of the intake of medicines, pain, general periprocedural discomfort. It also shortens the time of postoperative rehabilitation. Simultaneous execution of the therapeutic process reduces the cost of treatment, optimizing the therapeutic process and its impact on the environment by reducing the use of materials and medical substances. The method of the invention may be combined with the known, above-described methods leading to induce gastric fullness. The method according to the invention can also be applied in the treatment of other diseases, such as oncology-reconstructive surgery, particularly with the mammary gland, the treatment of complications after radiotherapy and classic burns, reconstructive surgery, cosmetic and aesthetic surgery, treatment of non-healing wounds, diseases of urinary incontinence.
Autologous transfer process consists of three steps. In the first stage, fat is removed from the patient body from the place indicated by the doctor. Removing is technically identical to the liposuction surgery, which involves using a special cannulas to take from under the patient's skin excess of body fat. This is done by mechanical or vacuum-assisted method, ultrasound, laser and special fluids.
The second stage is carried out as stepwise treatment / processing of adipose tissue using a special device or laboratory methods. This step involves exposing a standardized treatment of adipose tissue collected from the patient. First, adipose tissue is repeatedly washed in order to remove erythrocytes, the excess of saline, substances used in liposuction and other polluting tissue. Then the resulting substrate is subjected to enzymatic treatment with the method using a special enzyme. At this stage there is a fat and intercellular connections digestion and a release of active ADRC cells. The final step of this stage, and also the most time-consuming, is the concentration of substrate in order to obtain a cell suspension containing the stem cells and regenerative cells (ADRC) by centrifugation with the alternate washing of the substrate. The result of these steps is to obtain a homogeneous deposit of stem cells and regenerative ADRC cells directly applicable in surgical procedures.
The last step is autologous transplant (autograft), in which to the submucosa tissue or muscle in the area of the gastric cardia and fundus, are administered homogeneous mixture of ADRC with or without the addition of fat graft (purified adipose tissue).
Administering a mixture of stem and regenerative ADRC cells in the area of gastric cardia and the fundus area according to the method of the invention leads to induce a feeling of gastric fullness, neurohormonal induction of satiety response, improvement of the function of the lower esophageal sphincter and humoral actions of own fat.
Administration of a mixture of stem and regenerative ADRC cells in the area of the lower esophageal sphincter is carried out to regenerate and improve the functional activities of the area, thereby prevent gastro-oesophageal reflux.
Method of administration, place and number of cells in each case depends on the circumstances and the decision of the medical doctor. In case of a additional amount of ADRC cells, they may be placed in storage or subsequent use for example in the case of difficult to obtain from a patient in the future.

Claims

Claims
1. Method for treating obesity and overweight and gastro-oesophageal reflux disease, characterized in that the stem and regenerative cells extracted from patient's own adipose tissue (ADRC - Adipose Derived Regenerative Cells) are injected into the submucosa tissue or muscle near the gastric cardia and fundus.
2. Method according to claim 1, characterized in that the isolated ADRC cells are given via endoscopy or surgical procedures, open or laparoscopic.
3. Method according to claim 1, characterized in that the isolated ADRC cells are enriched with fat graft in the amount of at least 5 ml and not more than 25 ml.
4 Method according to claim 1 , characterized in that is complementary to other bariatric procedures reducing the size of the stomach - such as adjustable gastric band, gastric sleeve partial resection, or filling the stomach - as intragastric implants, or affecting the motility or satiety induction by electrical stimulation (neurostimulators) .
5. Method according to claim 1, characterized in that it is used while other surgical procedures to obese or overwieght patients.
6. Method according to claim 1, characterized in that in treating gastro-oesophageal reflux diseasethe stem and regenerative cells extracted from patient's own adipose tissue (ADRC - Adipose Derived Regenerative Cells) are injected into the submucosa tissue or muscle near the gastric cardia and fundus.
PCT/PL2013/000063 2012-05-14 2013-05-14 Method for treating obesity and overweight and gastro-oesophageal reflux disease WO2013172724A1 (en)

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PLP.399176 2012-05-14
PL399176A PL399176A1 (en) 2012-05-14 2012-05-14 Method for treatment of obesity and overweight, and diseases gastro-oesophageal reflux

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2813155C1 (en) * 2023-09-21 2024-02-06 федеральное государственное бюджетное образовательное учреждение высшего образования "Северо-Западный государственный медицинский университет имени И.И. Мечникова" Министерства здравоохранения Российской Федерации Method of endoscopic treatment of patients with gastroesophageal reflux disease

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010130968A (en) * 2008-12-05 2010-06-17 Nippon Menaade Keshohin Kk Method for inducing differentiation of stem cell to brown fat cell
US20100160995A1 (en) 2008-12-18 2010-06-24 Jerome Dargent Method for treating obesity
WO2012155209A1 (en) * 2011-05-19 2012-11-22 Mesoblast, Inc Methods for treating obesity and/or metabolic syndrome
WO2013003595A1 (en) * 2011-06-29 2013-01-03 Biorestorative Therapies, Inc. Brown fat cell compositions and methods

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010130968A (en) * 2008-12-05 2010-06-17 Nippon Menaade Keshohin Kk Method for inducing differentiation of stem cell to brown fat cell
US20100160995A1 (en) 2008-12-18 2010-06-24 Jerome Dargent Method for treating obesity
WO2012155209A1 (en) * 2011-05-19 2012-11-22 Mesoblast, Inc Methods for treating obesity and/or metabolic syndrome
WO2013003595A1 (en) * 2011-06-29 2013-01-03 Biorestorative Therapies, Inc. Brown fat cell compositions and methods

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
TRAN THIEN T ET AL: "Transplantation of adipose tissue and stem cells: role in metabolism and disease", NATURE REVIEWS. ENDOCRINOLOGY, NATURE PUBL. GROUP, US, vol. 6, no. 4, 1 April 2010 (2010-04-01), pages 195 - 213, XP002636571, ISSN: 1759-5029, [retrieved on 20100302], DOI: 10.1038/NRENDO.2010.20 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2813155C1 (en) * 2023-09-21 2024-02-06 федеральное государственное бюджетное образовательное учреждение высшего образования "Северо-Западный государственный медицинский университет имени И.И. Мечникова" Министерства здравоохранения Российской Федерации Method of endoscopic treatment of patients with gastroesophageal reflux disease

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