Islet Transplantation for Type 1 Diabetes

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 am between 18 and 70 years old.

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.

I have serious heart problems, including a recent heart attack or weak heart muscle.

I am using glucocorticoids for reasons other than a transplant.

I weigh over 100 kg or my BMI is over 30.

I have developed proteinuria after my kidney transplant.

I have pancreatitis.

My cholesterol and triglycerides levels are high and untreated.

I do not have any active infections, except for mild skin or nail fungus.

I have had cancer before, but it was completely removed except for skin cancer.

I haven't taken any diabetes medication except insulin in the last 4 weeks.

My kidney function is low, with a GFR of 40 mL/min/1.73 m2 or less.

I have untreated or worsening eye damage due to diabetes.

Treatment Details

The 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.

1Treatment groups

Experimental Treatment

Group I: Islet TransplantExperimental Treatment2 Interventions

Islet transplantation into the gastrointestinal submucosa