CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 4 enrolled
Drug / intervention
Islet cell transplantationbiological
Likely dose
Allogeneic islet cell transplantation, up to 3 infusionsAI-extracted
Key inclusion· 7
  • ✓Type 1 diabetes mellitus for more than 5 years duration
  • ✓Age 18-65 years
  • ✓Unstable diabetes control with glucose >200 mg/dL and/or <80 mg/dL despite medical therapy
  • ✓Hypoglycemia unawareness with loss of cognitive function episodes
Key exclusion· 10
  • ✕Prior or current organ or bone marrow transplant recipient
  • ✕Known hypersensitivity to tacrolimus, sirolimus, daclizumab, or CellCept
  • ✕Active malignancy except basal or squamous cell carcinoma
  • ✕Evidence of active infection or pulmonary infiltrate

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

Search/NCT00214786
NCT00214786Phase 1Completed
CompareCT.gov

Pancreatic Islet Cell Transplantation - A Novel Approach to Immunosuppression and Validation of Remote Site Islet Cell Processing, Islet Cell Culture and Two-Layer Preservation

Baylor Research Institute·interventional·Posted Sep 22, 2005·Updated Jun 14, 2017

In Brief

A Phase 1 clinical trial evaluating Islet cell transplantation for Type 1 Diabetes. Completed, enrolled 4 participants across 1 site.

Detailed Summary

The purpose of this study is to assess a novel approach to immunosuppression in allogenic pancreatic islet cell transplant recipients. In addition, the study aims to assess remote site islet processing with culture for pancreatic islet cell transplantation in human subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
CollaboratorsBaylor Health Care System, University of Miami

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartApr 1, 2005
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago

Interventions

Islet cell transplantationbiological

Allogenic islet transplantation