CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
Autologous CD34+ stem cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00788827
NCT00788827Phase 1Completed

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

Imperial College London·interventional·Posted Nov 11, 2008·Updated Nov 18, 2019

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.6 years ago

Interventions

Autologous CD34+ stem cellsbiological

Up to 5 x 10 log 8 of autologous stem cells on a single occasion