RU2165263C1 - Method of treatment of patients with diabetes mellitus - Google Patents

Abstract

FIELD: medicine, endocrinology. SUBSTANCE: method involves preliminary administration polyacrylamide gel to patient with the following transplantation of pancreas beta-cells in its. Method ensures to decrease doses of insulin to be administrated. Invention can be used for treatment of diabetic patients. EFFECT: enhanced effectiveness of treatment. 2 ex

Description

 The invention relates to medicine, namely to the treatment of diabetes mellitus, mainly insulin-dependent, by transplantation of pancreatic beta cells.

 There is a known method for the treatment of diabetes mellitus, according to which cells of benign human insulinoma are implanted, while material containing β-cells of the pancreas is implanted in the rectus abdominis muscle (RF patent N 2004247).

 The disadvantages of this method include problems associated with the struggle with the predominance of fibroblast growth when using a transplantable culture of β-cells and the need for precise control of insulin performance by a specific fraction of the insulinoma cell culture, which is due to the fact that tumor cells are used as an implant, functional whose activity can vary significantly.

 Closest to the proposed method in technical essence and the achieved result is a method of treating diabetes by transplantation of material containing β-cells of the pancreas (RF patent N 2135193).

 A method of treating diabetes mellitus, mainly insulin-dependent, is carried out using a material containing mammalian pancreatic β-cells obtained using the phenomenon of β-cell migration.

 Material containing β-cells of the pancreas is transplanted into various organs and tissues; intramuscularly, into the rectus abdominis muscle, into the liver (into the parenchyma or through the portal vein), into the spleen pulp, into the splenic artery, into the peritoneal cavity, into the omentum, into a specially created muscle pocket.

 A disadvantage of the known method for the treatment of diabetes mellitus is the short duration of β-cell production of an insulin donor in the recipient organism due to the rejection effect of heterogeneous cells, as a result of which significant immunosuppressive therapy is required.

 The essence of the proposed method for the treatment of patients with diabetes mellitus is the duration of the existence and production of insulin by the pancreatic β-cells of the donor in the recipient's body, which is achieved by pre-injecting the patient with polyacrylamide gel subcutaneously, followed by transplantation of β-cells into the formed capsule.

 Material for β-cell transplantation is obtained from the pancreas of mammals (newborn piglets, rabbits, sexually mature green monkeys). Cultivation is carried out using standard media and solutions. To maintain β-cells in an active state, the method of gentle enzymatic treatment of the pancreas is used, which consists in the alternation of tissue contacts with the enzyme and the nutrient medium. As a result of the processing steps, pancreatic tissue fragments and β-cells are introduced into the culture vessels without centrifugation. Moreover, tissue disaggregation is carried out by 0.1-0.25% solution of trypsin and chymopsin in different sequences depending on the donor material. The enzymatic treatment of the tissue is completed during its contact with the medium using a Biotech-m flask, which provides for controlled mixing of the suspension on a magnetic table.

 The resulting cellular material is introduced into the connective tissue capsule of the recipient, which is formed by pre-injected subcutaneous polyacrylamide gel. The number of cells depends on the severity of the recipient’s disease.

 Example 1. Patient F., 37 years old. Insulin-dependent diabetes mellitus was diagnosed 11 years ago, a year after birth. Pregnancy was difficult: with toxicosis of the second half of pregnancy, nephropathology, significant weight gain up to 26 kg. The disease was unstable for all years, which required great efforts in the selection of adequate insulin therapy. Exogenous insulin consumption ranged from 58 u / day to 30 u / day. In the last two years, pathological changes in the kidneys have been diagnosed, which is defined as diabetic nephropathy. In urine tests, an increase in the upper border of proteinuria was noted 10-12 times. Increase in blood pressure to 170/110 mm Hg

 The patient was injected subcutaneously into a preformed capsule with a pancreatic cell culture of newborn rabbits. After 7 days, the patient noted an improvement in the general condition, a decrease in the feeling of thirst and dryness of the oral mucosa, and a decrease in blood pressure to 140/90 mm Hg. After 15 days, the patient's condition reduced the need for exogenous insulin from 30 units to 18 units (blood and urine control). After 30 days, the need for exogenous insulin decreased to 12 units / day, and by the end of the 2nd month to 4 units / day.

 The patient is observed for 12 months. There are no clinical manifestations of nephropathy, blood pressure is within the age norm. The patient was transferred to oral antidiabetic drugs with a prerequisite for maintaining a diabetic diet and controlling glucose in the blood, urine and glycosylated hemoglobin.

 Example 2. Patient K., 52 years old. Insulin-dependent diabetes mellitus was diagnosed from the age of 18 against a background of severe stress. The nature of the disease was initially unstably severe. Doses of exogenous insulin reached 70 units / day. In recent years, the nature of the course of the disease has stabilized, but worsening occurred after stressful situations and errors in the diet.

 In the last three years, there has been a deterioration in the state of the vessels of the lower extremities, a decrease in libido, a deterioration in erection and the quality of sexual intercourse. Diagnosed with diabetic angiopathy of the lower limbs and penis. The need for exogenous insulin over the past year from 20 units / day to 40 units / day.

 A pancreatic cell culture of 14 day old piglets was injected subcutaneously into the patient’s capsule. Two weeks later, the patient noted an improvement in general condition. After a month, the need for exogenous insulin decreased to 12 units / day. After 2 months - up to 6 units / day. 4 months after transplantation, the patient was transferred to oral antidiabetic drugs. The patient’s sexual life was normalized, and the state of the vessels of the lower extremities significantly improved.

 The subjective and objective symptoms of the examined patients, the data of additional research methods (blood, urine) suggest that this method of treating diabetes is highly effective, which leads to a significant reduction in patients' doses of exogenous insulin and, in some cases, refusal from insulin therapy. The method does not require immunosuppressive therapy, reduces the risk of secondary complications of diabetes mellitus: retino-, neuro-, nephropathy, can significantly improve the quality of life of patients. The therapeutic effect lasts, as a rule, from 10 to 20 months, depending on the severity of the disease. The number of transplanted cells is also determined by the severity of diabetes mellitus, in particular the amount of exogenous insulin consumed by the patient.

Claims (1)

 A method for the treatment of diabetes mellitus by transplantation of β-cells of the pancreas, characterized in that the recipient is pre-injected with a polyacrylamide gel followed by transplantation of pancreatic β-cells into it.