Islet Transplantation for Type 1 Diabetes
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial requires that you do not take certain medications that could affect blood sugar control, such as glucocorticoids and some psychiatric medications. If you are on any of these, you may need to stop them to participate.
How is islet transplantation different from other treatments for type 1 diabetes?
Islet transplantation is unique because it involves transplanting insulin-producing cells directly into the liver, which can help maintain normal blood sugar levels without the need for daily insulin injections. Unlike traditional treatments, it requires immunosuppressive drugs to prevent rejection, but it offers the potential for insulin independence and fewer hypoglycemic episodes.12345
What data supports the effectiveness of the treatment Islet Transplantation + Immunosuppression for Type 1 Diabetes?
Who Is on the Research Team?
Fouad Kandeel, MD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Islet Cell Transplantation
Participants undergo islet cell transplantation to evaluate safety and effectiveness in controlling type 1 diabetes
Immunosuppressive Treatment
Participants receive a glucocorticoid-free immunosuppressive regimen to prevent rejection of transplanted islets
Follow-up
Participants are monitored for safety and effectiveness after transplantation
What Are the Treatments Tested in This Trial?
Interventions
- Islet cell transplantation
- Islet Transplantation + Immunosuppression
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Institutes of Health (NIH)
Collaborator