Drug immunocorrective action on the basis of cell suspension and a method of treatment of diabetes mellitus with use of this drug

 

(57) Abstract:

Drug immunocorrective action on the basis of cell suspension is characterized by a specific composition and quantitative indicators of cell suspension obtained from native or cryopreserved hematopoietic stem cells embryonic liver and/or spleen person. Method of diabetes treatment is carried out by introducing said medication that is chosen from the tissue Bank of different designs to suit the individual indicators of the patient, and with the reintroduction of the drug use of the same sample. The drug provides amplification of the immune mechanism and allows you to achieve positive results in the treatment of diabetes. 2 S. and 4 C.p. f-crystals, 12 tab.

The invention relates to medicine, in particular for cell therapy and can be used for the treatment of diseases caused by disorders of the immune system, for example, diabetes mellitus.

In recent years in the field of research using human cadaveric fetal tissue has seen dramatic progress. Developed a new category of care is vigotovlennya from the tissues of the embryo, to compensate for the lack of functional activity of the damaged, painful tissues.

Cell transplantation is an attractive alternative to transplantation of organs and tissues, because the benefits of embryonic cells is that they have not formed a hard individual signs histocompatibility antigen, they engraftment easily and not cause a reaction graft-versus-host. In addition, cells have a strong potential for life. They proliferate, differentiate, are the source of huge amounts of biologically active substances. Currently using cell suspension prepared from embryonic brain, bone marrow, liver, spleen, thymus, pancreas, kogemustega flap.

The first most successful attempts to use the cell suspensions as drugs have been associated with fetal liver and spleen person. It is known that in the liver or spleen of a human embryo in age from 5 to 16 weeks is blood with a high content of stem cells. In these terms the development of the embryonic cells of the liver and spleen only slightly expre the drug on the basis of cell suspension native liver cells of the embryo 7 weeks of gestation and at the expense of its introduction was restored haematopoiesis patient with aplastic anemia (Kelemen E. Second J. Gematol., 1973, v.10, N 4, p. 305-308).

In recent years, varying by various methods preparation of cell suspensions, as well as various application methods, researchers were able to achieve positive results in the treatment of primary and secondary myelodepression States. These drugs, in particular, described in Izzi, T., Polehi O., et al, Fetal liver transplantation, Alan R. Liss, 1985, pp 237-249).

The second direction of the clinical application of these cell suspensions were violations of immunity, the most significant experience belongs Touraine J. I(Transplantation Proceedings, 1993, v.25, No. 1, pp 1012-1013). In the excellent work Baechelta R, et al, I. Clin. Invest, 1993, v.91, March, 1067-1078) shows long-term results of treatment of patients with severe combined immune deficiency, when not only restored the levels of immunity in these patients, but showed the presence of the split chimerism and the emergence of tolerance to antigens of both host and donor.

The authors also include their experience in the treatment of immune disorders in blood diseases using cell suspensions.

However, the use of these drugs for treatment, in particular, diabetes mellitus the authors do not know.

As you know, IU is rgans cellular and circulating antibodies. Therefore, in the next in the treatment of insulin-dependent diabetes used drugs, substances, fabric, designed to interrupt the autoimmune destruction of pancreatic cells in type immune. This purpose was used isoprinosine, azathioprine, cyclosporine, and drugs on the basis of biological materials, in particular, preparations of thymus.

Thus, the known drug derived from the thymus gland, thymalin, isolated from calf thymus, and its application as immunocorrector in the treatment of diabetes (Kurbanov, So, Kalbeeba B. M., Zakiev, So That problems of endocrinology, 1989, T. 35, N 6, S. 7-9).

However, a disadvantage of the known method is that the daily requirement of insulin decreases by only 15 to 20%. Reduction of blood glucose level is kept within 5-6 months. In addition, the adjuvant often does not provide full recovery of immunological parameters, and increases them selectively by a certain percentage without reaching normal levels.

The basis of the invention the task is to create such a drug immunocorrective action on the basis of cell suspension in which due optimalnomu results in the treatment of diabetes.

The problem is solved in that the medicines immunocorrective action on the basis of cell suspension prepared from native or cryopreserved hematopoietic cells of the liver and/or spleen of a human embryo, according to the invention, the number of nucleated cells in said suspension is from 5 to 90106/ml, the number of colony forming units granulomonocitarnyi range from 20 to 80103/ml, the number of colony forming units of blasts from 0.5 to 9103/ml and the number of early precursors of haematopoiesis from 1 to 9106Jr.

It was empirically established that the choice of such indicators of cellular composition and their quantitative ratios allow to achieve positive results in the treatment of diabetes, namely the transition of the underlying disease in remission.

The authors suggest that this part of the claimed medicinal preparation can affect the immune mechanism, in particular, to stop the aggression of T-lymphocytes and immunoglobulins against cells. In addition, the drug for the claimed composition as a source of biologically active substances, malinali permeability, migration of cells, their differentiation, which ultimately determines the completeness of the inflammatory process and reducing the effects of malnutrition.

According to the invention, it is advisable that when cryoconservation of drug is additionally contained dimethyl sulfoxide in an amount of from 3 to 10%. The choice of the lower limit is determined by the largest possible safety of the cells and the upper bound is based on the toxic effect of the drug.

The problem is solved in that in the method of treatment of diabetes, which consists in the introduction of biological material immunocorrective action, according to the invention, as biological material immunocorrective action use the patented drug.

The authors believe that medicines on the basis of cell suspension previously never been used for the treatment of diabetes. However, long-term research work on studying the mechanisms of the effects of drugs on the basis of cell suspensions on the processes of treatment of various diseases allows to assert that the cell suspension of the proposed structure very successfully can be used to treat Saharna is which is described in detail in the Examples below. In patients observed a significant improvement in the immune status, until recovery 3-11 day (increase in the number of T-lymphocytes, a change in the ratio of subpopulations, normalization of parameters of humoral immunity). Was reduced initial dose of insulin by 40-70%. For 3-4 weeks was achieved remission.

In accordance with one aspect of the present invention, it is expedient patented drug to enter at a dose of 0.5 ml to 5 ml

In addition, it is desirable that this drug was introduced before and/or after treatment with cytotoxic drugs.

Medication it is advisable to choose from the tissue Bank of different designs to suit the individual indicators of the patient, with re-introduction of the drug use of the same sample.

The proposed method for the treatment of diabetes allows the introduction of patented cell suspension to korrigirovat various violations that determine the course of diabetes, in particular, insulin resistance, development of macro - and microangiopathy, lesions of the kidneys, liver, development of anemia, thrombocytopenia, and so on, Voss is no more understandable from the following detailed description of its implementation, set forth in the specific Examples of its implementation.

The drug for the claimed composition can be manufactured using the following method:

Embryos were obtained when induced termination of pregnancy in healthy, pre-screened for the presence of viral and himicheskih infections women. Using embryos for a period of from 5 to 8 weeks of gestation. In order to preserve the integrity of embryo abortion performed by wakuumaspiratiou. The embryo is transferred into a sterile container with Hanks solution and antibiotic /aminoglycosides/. Further work is being done in a sterile ward. Embryos are transferred to sterile Petri dishes filled with Hanks solution with antibiotic, where, carefully opening the abdominal cavity, remove the liver, spleen, of which separately prepare a cell suspension.

Krovetvorenie bodies placed in a homogenizer, cut into small pieces and ground to a homogeneous mass. Cells are washed from the walls and pestle homogenizer Hanks solution in a measuring tube, passing through the filter for transfusion of blood products, and then through needles of decreasing diameter. Part of the prepared suspension is transferred into a polyethylene is the Other part subject cryopreservation.

As cryoprotectant used dimethyl sulfoxide (DMSO, analytical grade). Before using DMSO passed through millionby filter (with a pore diameter of 0.22 μm.). With a light mixing cell suspension is added dropwise equal volume of the working solution of DMSO, reaching concentrations in the preferred embodiment, 5%.

Cell suspension is poured into plastic containers depending on further goals from 0.5 to 2 ml.

The containers are placed in the camera software freezer running on liquid nitrogen and frozen to -196oC.

Cryopreserved suspensions are stored in the Bank embryonic tissues in liquid nitrogen at a temperature of -196oC.

After preparation of cell suspension, define the following parameters: 1 - the number of nucleated cells in 1 ml, 2 nd - the number of colony forming units granulomonocitarnyi number (CFU GM) in 1 ml, 3 - the number of colony forming units of blasts (CFU BL.) 1 ml, 4-th - the number of early precursors of haematopoiesis (CD34in 1 ml.

And used and stored in the tissue Bank of cell suspension, the following: a< / BR>
4th from 1 to 9106ml-1< / BR>
Prenatal diagnosis involves testing for syphilis, HIV, viral hepatite B and C, toxoplasmosis, cytomegalovirus infection. Research the contents of containers for bacterial sterility.

Fetal diagnosis includes testing for HIV, viral hepatite B and C, cytomegalovirus, rubella virus, herpes and toxoplasmosis.

Depending on the clinical treatment of drug administered one of the following methods:

- introduction (transplantation) part native hematopoietic cells, further introduction of cryopreserved cells stored in the Bank of this sample;

- the introduction of an entire native sample;

- introduction of part or all of cryopreserved material of this sample;

Before and in some cases after the introduction of the patented drug treatment one or a combination of cytotoxic drugs in order to reduce the immunological reactivity of the recipient, reducing the autoimmune aggression.

The treatment effect estimate in the reduction of blood glucose, reduce the dose of ins is TS T-B-lymphocytes, immunoglobulins/; the number of peripheral blood erythrocytes containing fetal hemoglobin; the presence of cells containing the Y chromosome, determined by the method of chain polymerisation reaction using oligonucleotide primers.

Detailed description of the use of patented inventions in the authors ' clinical practice are presented in Examples 1-7.

Example 1. Patient D., 1946, R., enrolled in the diabetes branch of the Ukrainian scientific research Institute of endocrinology and metabolism 21.08.93, complaining of severe weakness, dizziness, shortness of breath with little exertion, palpitations, poor appetite, nausea, itching, headache, swelling in the legs, reduced vision.

From the anamnesis it is known that 13 years ago revealed insulin-dependent diabetes mellitus. Constantly received insulin was observed at the endocrinologist, was periodically treated in hospital. In the past two years, notes the deterioration: appeared arterial hypertension, the underlying disease course acquired labile nature, in the analysis of urine is constantly protenuria. Over the past year appeared weak, occasionally swelling of the lower extremities, disparities in the neurological Department of the regional hospital, the presence of chronic renal failure, anemia of moderate severity. 4 transfusions. After a temporary improvement in the condition deteriorated sharply in September 1993, what was the reason for hospitalization.

At admission the patient's condition is severe. Clear consciousness. Skin and visible mucous membranes pale. Peripheral lymph nodes are not enlarged. Pulse 98 beats/min, rhythmic, satisfactory filling and voltage. Blood pressure 190/120 mm RT. Art. heart sounds sufficient sonority, rhythm, systolic murmur at the apex, the accent of II tone of the aorta. In the lungs are heard and vesicular breath. The abdomen is soft, moderately swollen, sensitive to palpation in the right hypochondrium. The liver stands out from the edge of the right costal arch on the right srednechrochnoy line 2 see the Spleen is not enlarged. Segments of the colon spazmirovanne. Chair - 4 times a day, pasty. Daily diuresis up to 1 L. the Face, feet, legs swollen.

Diagnosed with diabetes mellitus, type 1, heavy form, in a state of decompensation. Diabetic universal angiopathy (nephropathy Art. III, CRF 1 tbsp.; vascular form of proliferating retinostat. Anemia severe stage. Symptomatic hypertension.

Admission glycemia and 12.4 mmol/l, glucosuria - 22 g/l, acetonuria - (+ +), proteinuria and 3.3 g/l, Erythro - and cylindruria (5-in field of view),+- 5.2 mmol/l, urea - 14,42 mmol/l, creatinine - 0,220 mmol/l, erythrocytes - 2,11012/l, hemoglobin - 64 g/L.

Treatment: diet therapy, insulin therapy is 22 IU/day., detoxification therapy (chelators, gemodez, lavage), diuretics, hypotensive, angiography, angioprotectors, correction of electrolyte balance, iron preparations, vitamin.

Three weeks later the patient's condition has improved somewhat: compensated carbohydrate metabolism, swelling went down, HELL decreased to 170/100 - 110 mm RT. Art. But remained persistent severe anemic syndrome.

15.09.93 were transplantation native hematopoietic cells embryonic human liver (sample TS-82H): the age of the embryo 5 weeks, the number of nucleated cells - 25106/ml, volume of added tissue - 1.5 ml, CFU GM-13,9103SOME BL. -1,3103/ml, CD34- 2,4106/ml. Way of introduction, intraosseous (vnutrigrudne).

The patient underwent transplantation of Devletleri headache, weakness, nausea, appetite improved, the patient for the first time over the last few months quietly slept. On the day 3 increased levels of hemoglobin, erythrocytes and reticulocytes in the peripheral blood with normalization to 10 days (Table. 1), phased in over three weeks significantly improved urine (Tab. 2). Decreased blood pressure to 160/100-90 mm RT. century, which allowed to reduce the dose of antihypertensive drugs.

Example 2. Patient P., born in 1960, he enrolled in the diabetes branch of the Kiev scientific research Institute of endocrinology and metabolism 6.11.91, with complaints of General weakness, weight loss, dry mouth, thirst, excessive urination. Considers himself ill since September 1991, when he first showed similar complaints. Were not surveyed. The sharp deterioration in November 1991, was forced to seek medical help.

Diagnosed with diabetes mellitus, type 1, first identified, severe, in a state of decompensation, diabetic ketoacidosis.

On admission, the blood glucose level was 15 mmol/l, glucosuria of 41.6 g/l, acetonuria - /+++/. Prescribed treatment: insulin - 60 IU per day, vitamin therapy, drugs potassium.

After reaching the compensation from which letenky person (sample SS - 63HL): the age of the embryo 7 weeks, the volume of injected cells ml - 1, number of nucleated cells 36,2106/ml, CFU GM 23,6103/ml, CFU nl. - 2,5103/ml, CD34- 1,4106/ml route of administration is intravenous. The amount of transplanted cells from the total tissue mass of this sample, located in the Bank of cryopreserved tissues, was 66%.

Transplantation patient satisfactorily. The first day saw the syndrome early posttransplantation improve General health: reduction of weakness, appetite improved, the patient became more cheerful, active.

Three weeks after transplantation appeared hypoglycemic condition that caused the gradual reduction of the daily dose of insulin, with a maximum decrease of 2.5 months (Table. 3).

Observed normalization of indicators of immune status on the 11th day (Table. 4). Within six months after the first transplant patient was in a compensated state with a stable and relatively low daily dose of injected insulin.

At the end of may 1992, the patient's condition deteriorated: there are signs of decompensation of carbohydrate metabolism, deteriorated performance imunna transplantation of cryopreserved hematopoietic stem cells embryonic liver of the same sample: N SS - 63HL - put 0.5 ml of cell suspension. Transfusion of the patient satisfactorily. The positive dynamics of the daily dose of insulin, indicators of immune status are given in Table. 3, 4.

Dynamics of changes in the number of erythrocytes containing fetal hemoglobin indicates the substitution effect of the transplanted cells.

Example 3. Patient R. , born in 1961, he entered the 1st medical Department of CRH Zaliznychna district, Kyiv 1.12.92, complaining of severe weakness, weight loss, dry mouth, thirst, excessive urination, headache, loss of appetite.

Considers herself a patient since October 1992, when the deterioration state. Were not surveyed. The sharp deterioration of in the end of November 1992 was the reason for the referral.

Diagnosed with diabetes mellitus, type 1, first identified, severe, state compensation, diabetic ketoacidosis. On admission, the blood glucose level was - 20.0 mmol/l, glucosuria - to 52.4 g/l, acetonuria - /+++/. Prescribed treatment: insulin - 64 IU per day, vitamin therapy, drugs, potassium, gemodez 200,0 through day N 6. Prescribed for the patient azathioprin in STM control peripheral blood. Upon reaching the specified therapeutic dose treatment was carried out on a weekly control of the number of leukocytes, platelets, erythrocytes in the peripheral blood.

32 days from start of treatment with azathioprine in achieving subcompensation disorders of carbohydrate metabolism 5.1.93, produced by transplantation of cryopreserved hematopoietic stem cells embryonic human liver /sample SS - 44H/: the age of the embryo 6 weeks, the volume of injected cells ml - 1, number of nucleated cells 17,5106/ml, CFU GM 24,8103/ml, CFU nl. - 1,7103/ml, CD34-2106/ml, the method of administration is intravenous. The amount of transplanted cells from the total tissue mass of this sample, located in the Bank of cryopreserved tissues, amounted to 45%.

Transplantation the patient satisfactorily. The first day saw the early post-transplantation syndrome improve the overall condition: reduced weakness, headache, improvement of appetite.

Treatment with azathioprine was continued for 48 days after transplantation of hematopoietic cells of the embryonic human liver.

2 weeks after transplantation appeared hypoglycemic condition that the month, /Table. 5/.

By the end of the second week of normalized indices of immune status of the patient /Table. 6/.

Dynamics of changes in the number of peripheral blood erythrocytes containing fetal hemoglobin indicates the substitution effect of the transplanted cells.

Remission of the disease lasts for more than 9 months.

Monitoring continues.

Example 4. Patient L., born in 1991, was in the endocrinology Department of the Children's specialized hospital No. 14, Kyiv with 15.09.93, 26.09.93,

Diagnosis: Insulin-dependent diabetes mellitus, severe, unstable current, state of subcompensation.

The disease is diagnosed in February 1993, when in a pre-coma state, the child was taken to the intensive care unit.

Diagnosed with diabetes mellitus type 1. Started insulin therapy - 8 IU/day. In the following months, the daily insulin dose was reduced to 6 UNITS. The nature of the flow of the main process was unstable: frequent hypoglycemic events in alternation with ketoacidosis. Hospitalized in the endocrinology Department for transplantation of hematopoietic embryonic glue the no.

12.09.93, produced by transplantation of cryopreserved hematopoietic stem cells embryonic human liver (sample SS - 91H): the age of the embryo is 5 weeks, the number of nucleated cells 25,0106/ml, volume of added tissue - 1.5 ml, CFU GM 23,9103/ml, CFU nl. - 1,8103/ml, CD34- 4106/ml route of administration is intravenous.

Patient underwent transplantation satisfactorily. According to mother, the child's appetite was improved by the evening after transplantation, the dream became calm, deep. On the fourth day after transplantation reduced the daily dose of insulin to 5 UNITS. In the future, daily insulin requirements remained the same.

During the month of normalized immunological parameters of patients (Table. 7).

Throughout the time after transplantation, the child remains satisfactory: stabilized the disease - glycemia during the day at 4.5 - 7,3 mmol/l hypoglycaemia episodes of ketoacidosis was not observed. Decreased irritability, tearfulness. Psihofizicheskie girl develops according to age. Monitoring continues.

Example 5. Patient A., born in 1969, we 12.08.93,

Diagnosis: Insulin dependent diabetes mellitus, severe, unstable for state compensation, diabetic universal angiopathy Art. II, diabetic peripheral polyneuropathy. Chronic diagnostics in the phase of remission.

Considers himself ill since 1986, when after a strong emotional surge began to worsen mood: weakness, polydipsia, polyuria, weight loss body. After 2 months, when I applied for medical aid, diagnosed insulin-dependent diabetes mellitus. Compensation status achieved with a daily dose of insulin 64 UNITS.

In the past year marks the appearance of pain in my legs, mostly at night, burning, tingling, sometimes numbness, cramps in the calf muscles. The main disease is acquired labile character: frequent change of the satisfactory condition of ketoacidosis or hypoglycaemia with small changes in food intake, physical and emotional stress.

The patient was hospitalized in the internal medicine Department for transplantation of hematopoietic stem cells embryonic human liver.

Admission glycemia during the day is>/P>28.07.93 were transplantation native hematopoietic cells embryonic human liver (sample S - 101H): the age of the embryo - 6 weeks, the number of nucleated cells 8,5106/ml, volume of added tissue - 2.5 ml, CFU GM - 23103/ml, CFU nl. - 2,4103/ml, CD34- 3,8106. The method of administration is intravenous.

Patient transplantation satisfactorily. After 8-10 hours observed the occurrence of a syndrome of primary post-transplantation to improve the General condition: reduced weakness, increase efficiency, improve sleep.

Within two weeks reduced insulin requirements to ED per day. In clinical studies, significant changes occurred (within normal limits before and after transplantation). Recovered indicators immunologische status at 1 month (Table. 8).

Increased levels of erythrocytes containing fetal hemoglobin, up to 15%.

Monitoring continues for longer than 12 months. The patient feels well there is a persistent payment status, no episodes of ketoacidosis.

Daily dose of insulin is at level 50-52 ED. Erythrocytes containing fetal, hemogl the Department of the Central clinical hospital of Zaliznychna district, Kiev with 12.04.93, 26.05.93, Diagnosis: diabetes mellitus, type 1, severe form of the condition subcompensation, universal diabetic angiopathy: micro - macroangiopathy vessels of the lower extremities Art. III, retinopathy, nephropathy II century ; trophic ulcer 1 finger on the right foot, cellulitis of the foot. Diabetic polyneuritis.

At admission the patient complained of General weakness, fever up to 38.5oC, chills in the morning, swelling, sensation of fullness in the right foot, ulceration of the soft tissues 1 finger on the right foot, feeling numb, tingling in legs, pain in legs at rest and during exercise.

Suffers from insulin-dependent diabetes for 22 years. In the last 5 years, there have been complaints of pain in the legs when walking, calming alone, as well as numbness, tingling in the legs, mostly at night. A month ago in the 1st finger of the right foot was opened ulcer soft tissues.

The patient was treated as an outpatient with no result. After another bath abruptly swollen foot, tibia, increased pain, there were severe flushing of the skin, increased body temperature up to 38oC. Immediately after admission revealed cellulitis, Arata, the insulin - 38 UNITS per day. The patient's condition has not changed: continued rises in body temperature in the evening to 38,6oC, continued General weakness, purulent discharge from the incision and trophic ulcers. After three days the patient to listen to right inferior pneumonia. Produced by bacterial blood cultures, urine, feces. From the blood of inoculated Staphylococcus aureus. The patient received 3 courses of antibiotic therapy for three weeks /ampioks, gentamicin, rifampicin, claforan/. In the analysis of blood leukocytosis with a shift of leukocyte formula to the left, accelerated erythrocyte sedimentation rate, mild anemia /table 9/. In the immunological sharply reduced the number of T-lymphocytes, slightly increased the number of lymphocytes per table of 10/.

In order to enhance immune protection 10.05.93 were transplantation native hematopoietic cells embryonic human liver /sample SS - 57H/: the age of the embryo - 8 weeks, the number of nucleated cells 37,5106/ml, volume of added tissue - 2.5 ml, CFU GM - 42103/ml, CFU nl. - 1,3103/ml, CD34- 1,4106/ml, the method of administration is intravenous.

After 8-10 hours after transplantation was observed manifestations of the syndrome of primary posttranslational improve about the Yu slept quietly. Gradually over 7-10 days normalized blood counts /Table. 9/.

The cleansing of wounds and ulcers from pneumonectomies masses. On the seventh day appeared healthy granulation and began epitelizatia. After two weeks, ulcer and wounds have healed.

Observed recovery of immune status on the 14th day /PL. 10/.

Due to the occurrence of hypoglycemia on the fifth day the daily dose of insulin was reduced to 34 UNITS.

The patient was discharged home in good condition.

Example 7. Patient B., born in 1957, he enrolled in the diabetes branch of the Kiev scientific research Institute of endocrinology and metabolism 4.09.92, complaining of severe weakness, thirst, dry mouth, excessive urination, weight loss, poor appetite, headaches.

Considers herself a patient in the last three months, when it gradually began to deteriorate the condition. Were not surveyed and are not treated. The sharp deterioration was the reason for the referral.

Diagnosed with diabetes mellitus, type 1, first identified, severe, decompensated diabetic ketoacidosis. Admission glycemia at 20.2 mmol/l, glucosuria was 51.2 GH">

After reaching subcompensation state produced by transplantation of native hematopoietic cells embryonic human liver /sample SS - 20HL/: the age of the embryo - 7 weeks, the number of nucleated cells - 25106/ml, volume of added tissue to 1 ml, CFU GM - 19,3103/ml, CFU nl, - 2,1103/ml, CD34- 1,8106/ml route of administration intravenous. The amount of transplanted cells from the total tissue mass of this sample, located in the Bank of cryopreserved cultures, amounted to 50%.

Transplantation the patient satisfactorily. The first day saw the early post-transplantation syndrome improve the overall condition: reduced weakness, headaches, improving appetite, sleep. Third day after transplantation in connection with occurrence of hypoglycemia began to reduce the daily dose of insulin with a maximum decrease after 2.5-3 months /Table. 11/.

Positive dynamics of the immunological parameters of the patient b presented in Table. 12.

Dynamics of changes in the number of erythrocytes containing fetal hemoglobin indicates the substitution effect of the transplanted cells.

Remission of the disease lasts for more dvenadcati for the use of the drug to break autoimmune aggression against the islets of Langerhans; to reduce the dose of insulin by removing the cell blockade with preserved cells; reduce or remove lability flow; reduce immunoresistance; restore haematopoiesis; to reduce such complications of diabetes as infectious diseases, micro - and macroangiopathies, neuropathy.

In addition, the cell suspension of the claimed composition can be stored in the pharmacy-banks of cryopreserved tissues and, given the lack of necessary definitions histocompatibility antigen, suppose if there are indications for a simpler application than, for example, the transfusion of blood.

1. Drug immunocorrective action on the basis of cell suspension prepared from native or cryopreserved hematopoietic stem cells embryonic liver and/or spleen, characterized in that the number of nucleated cells in this suspension is from 5 to 90106ml-1the number of colony forming units granulomonocitarnyi range from 20 to 80103ml-1the number of colony forming units of blasts from 0.5 to 9103ml-1the number of early precursors of haematopoiesis from 1 to 9106ml-1.

2. The drug under item 1, otlichayushiesya from 3 to 10%.

3. A method of treating diabetes mellitus, which consists in the introduction of biological material immunocorrective action, characterized in that the material immunocorrective action used drug under item 1.

4. The method according to p. 3, characterized in that said drug is administered in a dose of from 0.5 to 5 ml.

5. The method according to p. 4, characterized in that said drug is administered before or after treatment with cytotoxic drugs.

6. The method according to any of paragraphs.3 to 5, characterized in that the drug is chosen from the tissue Bank of different designs to suit the individual indicators of the patient, and with the reintroduction of the drug use of the same sample.

 

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