Islet Transplantation for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen by Fouad 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.

Research Team

Fouad Kandeel, MD

Principal Investigator

City of Hope Medical Center

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

Ability to give informed consent

My liver is healthy.

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

Exclusion Criteria

You have a high body mass index (BMI).

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

I currently have an ongoing infection.

Treatment Details

Interventions

• Islet cell transplantation (Cell Therapy)
• Islet Transplantation + Immunosuppression (Immunosuppressant)

Trial Overview 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.

Participant Groups

Group I: 1 Experimental Treatment 2 Interventions

Islet cell transplantation alone

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University