Islet Transplantation for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen byAndrew M Posselt, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

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.

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

My c-peptide levels are very low after a special drink test.

I was diagnosed with Type 1 Diabetes before 40 and have been on insulin for over 5 years.

I had a kidney transplant over 3 months ago and am on specific immune-suppressing drugs.

See 5 more

Exclusion Criteria

My blood pressure is still high despite taking medication.

I have an active stomach ulcer, symptomatic gallstones, or high blood pressure in the liver.

I use more than 1.0 IU/kg/day or less than 15 units/day of insulin.

See 23 more

Treatment Details

Interventions

Islet cells (Cell Therapy)
Islet transplantation into the gastrointestinal submucosa (Cell Therapy)

Trial OverviewThe study tests the safety and effectiveness of transplanting islet cells into the stomach's lining in people with Type 1 Diabetes who've had a kidney transplant. Six patients will be enrolled to receive this treatment and monitored for up to three years post-transplant.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Islet TransplantExperimental Treatment2 Interventions

Islet transplantation into the gastrointestinal submucosa