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Treatment of Patients with New-onset Insulin-dependent Diabetes Mellitus with the Use of Fetal Cell Suspensions

Novytskaja Alla, Smikodoub Alexander

Cell Therapy Clinic of National Medical University and Embryonic Tissues Center EmCell

20 patients aged 1 to 35 with clinical diagnosis of initially revealed insulin-dependent sugar diabetes were subjected to transplantation of human fetal cells possessing hypoglycemic and immunocorrecting effect.

Suspension characteristics were as follows:
  • embryo age was 5 to 9 weeks of gestation;
  • suspension composition: stem cells of human fetal hemopoiesis and hepatocytes;
  • suspension amount: 1 to 4 ml;
  • amount of CD34: 0.28 to 0.8x106/ml;
  • amount of CPU GEMM: 2.1 to 9x103/ml.
Method of administration: intravenous, drop-by-drop. Number of administrations: 14 patients were subjected to 1 transplantation each, and 6 patients were subjected to 2 transplantations each, intervals between transplantations being 2 to 10 months.

Transplantations were carried out 1 to 6 months after the diagnosis had been set. Duration of observation was 1 to 4 years.

  1. In all cases, 30 to 80% decrease in the daily insulin dosage was observed (45% for the total group). The peak of the decrease was noted after 14 to 90 days.
  2. Clinical remission (daily insulin dosage of 0.4 units/kg of body mass or complete drop of insulin therapy) developed in 65% cases. Subsequent administration of cell suspension prolongs remission (repeated administration to 6 patients).
  3. Restoration of normal immune status indices was observed on the 11th to 30th day.
No side effects or allergic reactions were observed.

Efficiency of cell therapy in case of initially revealed insulin-dependent sugar diabetes depends on the disease duration: the earlier transplantation is carried out, the more probable clinical remission is.