Islet Transplantation for Type 1 Diabetes
Trial Summary
What is the purpose of this trial?
The goal of this trial is to gain initial clinical experience regarding the safety and efficacy of treating type I diabetes in people who have received a kidney transplant by transplanting islets into a new transplant site in the stomach (gastrointestinal submucosa). A total of 6 patients will be enrolled in the study and followed for a period of up to 3 years after the last islet transplant.
Research Team
Andrew M Posselt, MD, PhD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for adults aged 18-70 with Type 1 Diabetes who have had a kidney transplant and are on specific immunosuppression drugs. They must have stable renal function, a history of severe hypoglycemia despite intensive diabetes management, and no production of c-peptide. Exclusions include active infections like hepatitis or HIV, recent use of other anti-diabetic drugs or investigational agents, certain cardiovascular conditions, untreated hyperlipidemia, pregnancy or unwillingness to use contraception.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Islet cells (Cell Therapy)
- Islet transplantation into the gastrointestinal submucosa (Cell Therapy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Suresh Gunasekaran
University of California, San Francisco
Chief Executive Officer since 2022
MBA from Southern Methodist University
Dr. Lukejohn Day
University of California, San Francisco
Chief Medical Officer
MD from Stanford University School of Medicine
Andrew Posselt
Lead Sponsor