At a glance
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A Phase I Safety and Tolerability Study Following the Infusion of Autologous Expanded Progeny of an Adult CD34+ Stem Cell Subset (InsulinCytes) to Patients With Type I Diabetes Mellitus and a Successful Renal Transplant
In Brief
A Phase 1 clinical trial evaluating Autologous CD34+ stem cells for Type 1 Diabetes and Type 2 Diabetes. Completed, enrolled 7 participants across 1 site.
Detailed Summary
This is a phase I study to assess the safety and tolerability of infusing expanded stem cells into the pancreas of patients with type I diabetes and a successful renal transplant. The stem cells used in this study occur naturally in the body and are collected from each recipient by a procedure called leukapheresis. The cells are then expanded and differentiated into insulin-like cells in a sterile suite before being injected into the body or tail of the pancreas of the recipient.
Study Details
Timeline
Interventions
Up to 5 x 10 log 8 of autologous stem cells on a single occasion