Islet Transplantation for Type 1 Diabetes

Palo Alto (17 mi)

Overseen byFouad Kandeel, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the safety and effectiveness of islet cell transplantation alone (ITA) in patients with difficult to control type I diabetes. Difficult to control type 1 diabetes is defined as wide swings in blood glucose that disrupt the patient's life and result in frequent episodes of low blood glucose despite the proper use of standard insulin therapy and frequent blood glucose monitoring.

Eligibility Criteria

This trial is for adults aged 18-65 with difficult to control Type 1 diabetes, experiencing severe blood sugar fluctuations despite using insulin and monitoring. Candidates must have had diabetes for at least 5 years, no chronic kidney or liver disease, and be able to follow a strict post-transplant regimen. Exclusions include significant heart disease, certain immune responses (high antibody levels), obesity (BMI over 30), active infections, substance abuse, psychiatric issues affecting treatment adherence, and any history of cancer except specific skin or cervical cancers.

Inclusion Criteria

My liver is healthy.

I have had Type 1 diabetes for over 5 years and it's hard to control.

I check my blood sugar at least four times a day and keep detailed records.

I often have low blood sugar episodes that I can't feel or that need help.

I am between 18 and 65 years old.

My kidneys are functioning well without significant protein loss.

Exclusion Criteria

I am on long-term medication for a chronic illness.

I have a serious heart condition.

I am not pregnant, breastfeeding, and I am willing to use effective contraception.

I am at a higher risk of bleeding or I am on long-term blood thinners.

I do not have an untreated mental health condition that could affect a transplant.

My cholesterol levels are high despite treatment.

I have anemia or another blood disorder that needs treatment.

I have a serious liver condition.

Treatment Details

The study tests the safety and effectiveness of islet cell transplantation without steroids in managing Type 1 diabetes that's hard to control with standard treatments. It involves transplanting cells into patients who then receive an immunosuppressive drug regimen to prevent rejection of the new cells while avoiding glucocorticoids which can affect blood sugar levels.

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment2 Interventions

Islet cell transplantation alone