drugset / Trial / NCT00315614

Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus

NCT00315614

NaSingle-groupOpen-labelTreatment

Summary

SPECIFIC AIMS: * To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation. * To induce a state of donor specific tolerance and eliminate the need for continuous immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells with islets and utilization of the monoclonal antibody Campath-1H for induction of Immunosuppression. * To assess long-term function of successful islet cell transplants in patients with Type 1 diabetes mellitus. * To determine whether the natural history of the microvascular, macrovascular and neuropathic complications are altered following successful transplantation of islet

Timeline

Start
2000-12
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CD34 Bone Marrow Cell therapy Other
Subject Islet Cell therapy