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Islet Transplantation in Type I Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

NCT03791567 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2024-10-22

No results posted yet for this study

Summary

A Phase 3 clinical trial has been completed and demonstrated the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol.The objective in offering expanded access to donislecel (allogeneic islets of Langerhans for transplant; IND BB-11807) for the treatment of brittle T1D is to bridge the gap between completed clinical trials and marketing (i.e. approval by the FDA of a biological license application). Expanded access will allow clinical trial subjects, as well as patients outside a clinical trial, to receive treatment. New patients participating in the expanded access protocol are required to meet exclusion and inclusion criteria.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

Donislecel (allogeneic islets of Langerhans for transplant)

Intervention Description: The drug product consists of allogeneic human islets of Langerhans (islets) in serum-free transplant medium (indicator-free CMRL 1066 medium with HEPES, without sodium bicarbonate and supplemented with human albumin).

Sponsors & Collaborators

  • CellTrans Inc.

    lead INDUSTRY

Principal Investigators

  • Jose Oberholzer, MD · University of Illinois at Chicago

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03791567 on ClinicalTrials.gov