CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Allogeneic Islets of Langerhansbiological
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age 18 to 65 years
  • ✓Type 1 diabetes with onset <40 years and insulin-dependent for >5 years
  • ✓Absent stimulated C-peptide (<0.3 ng/ml) on mixed meal tolerance test
  • ✓Intensive diabetes management with ≥3 glucose self-monitoring checks daily and ≥3 insulin injections daily or insulin pump, supervised by endocrinologist with ≥3 evaluations in past 12 months
Key exclusion· 21
  • ✕Any previous transplant
  • ✕BMI >27 kg/m² or weight ≤50 kg
  • ✕Insulin requirement >0.8 IU/kg/day or >50 IU/day
  • ✕HbA1c >10%

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

Search/NCT00265473
NCT00265473Phase 2Completed
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hOKT3γ1 (Ala-Ala), Sirolimus and Low Dose Tacrolimus Therapy in Type 1 Diabetic Islet Allograft Recipients

University of Minnesota·interventional·Posted Dec 14, 2005·Updated Mar 9, 2017

In Brief

A Phase 2 clinical trial evaluating Allogeneic Islets of Langerhans for Type 1 Diabetes Mellitus and Hypoglycemia. Completed, enrolled 5 participants across 1 site.

Detailed Summary

This clinical trial is designed to extend the observations made in our pilot clinical trial (IND 8971, Study #1) on the safety and efficacy of immunotherapy with the anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala), (currently called MGA031) combined with sirolimus and tacrolimus in preventing rejection and autoimmune destruction of deceased donor pancreatic islet transplants in type 1 diabetic recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus, Hypoglycemia
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Juvenile Diabetes Research Foundation

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2005
Enrollment StartNov 1, 2005
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.6 years ago

Interventions

Allogeneic Islets of Langerhansbiological

Intraportal infusion of islets of Langerhans