Abstract on Presentation at the 9th IPITA Conference. Dublin (2003)

INTRAVASCULAR XENOTRANSPLANTATION OF FETAL PORCINE ISLETS - A CLINICAL TRIAL FOR TYPE I DIABETES
S.I. Tretjak, A.V. Prokhorov, and V.A. Goranov

Background: Transplantation of islets inside semipermeable membranes would create an immunological barrier between the host and the transplanted tissue. It gives a possibility to decrease or avoid of immunosuppressive therapy that are potentially can be more harmful to the patient than the disease itself. The important requirement for such device is enough diffusion of trophogenes that could be achieved by the transplantation of islets into vessel devices.
Patients and Methods: Nine patients with type I diabetes aged from 25 till 58 were transplanted intravasculary with polyamide macrocapsule contained (0.4-9)*10⁷ fetal porcine beta-cells. Insulin doses used for these patients before transplantation were 38 – 56 U/day and their HbA1c exceeded 9.5%. All recipients often had episodes of hypoglycemia (> 2 a month) and difficulties with correction of hyperglycemia in spite of often insulin injections and clinical treatment. The immunosuppression wasn’t used.
Results: During next 6 months after transplantation in all recipients the requirement for insulin was reduced in average on 15 – 25% vs. pretransplanted level. Some recipients (3) reduced their daily insulin on 25 – 45% during 1 year. In recipients episodes of hypoglycemia disappeared. Control of glycemia is restored and easy supported with help of basal-bolus regime of insulin treatment. Four patients had their weight increased (2-5 kg) and stabilized. After 6 months posttransplant patient’s HbA1c not exceeded 8.5%. No significant alterations of immunological status were observed during 6 months after transplantation. Interesting is the reducing of requirement in insulin didn’t correlate with amount of transplanted beta-cells.
Conclusions: This study demonstrates the perspective of xenotransplantation into vascular device as a perspective therapeutic method for treatment of type I diabetes.