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Islet Transplant for Type 1 or Surgical Diabetes

NCT01606475 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-08-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of islet transplants from human cadaver donors into type 1 or surgical diabetes mellitus patients who experience frequent acute or advanced chronic complications but do not qualify for other islet transplant trials. Under this protocol, patients may receive intraportal alloislet transplant under one of the following scenarios:

1. islet transplant alone
2. simultaneous islet-kidney transplant, or 3)islet after kidney transplant.

Conditions

  • Type 1 Diabetes Mellitus
  • Hypoglycemia
  • Labile Diabetes
  • End-stage Renal Disease

Interventions

BIOLOGICAL

Allogeneic islets of Langerhans

Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.

Sponsors & Collaborators

Principal Investigators

  • Bernhard J Hering, M.D. · University of Minnesota

Eligibility

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

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01606475 on ClinicalTrials.gov