Islet Cell Transplant 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 learn about the safety of islet transplantation for Type 1 diabetes mellitus, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is islet cell transplantation safe for humans?
Islet cell transplantation can lead to complications like intraportal thrombosis (blood clots in the liver's portal vein) and requires immunosuppressive drugs, which can have side effects. However, safety measures and quality controls are in place to ensure the safety, purity, and potency of the islets used in transplantation.12345
How is the islet cell transplant treatment for Type 1 diabetes different from other treatments?
Islet cell transplantation is unique because it involves transplanting insulin-producing cells from a donor into the patient's liver, potentially allowing them to produce insulin naturally and reduce or eliminate the need for insulin injections. However, it requires immunosuppressive drugs to prevent rejection, which can have significant side effects.678910
What data supports the effectiveness of the treatment Islet Cell Transplant for Type 1 Diabetes?
Research shows that islet cell transplantation can be an effective treatment for Type 1 Diabetes, with advancements improving success rates and long-term function of the transplanted cells. Although the success rate is lower than whole-organ pancreas transplants, islet transplantation is simpler, safer, and can be done on an outpatient basis, making it a promising option for managing diabetes.36111213
Who Is on the Research Team?
Piotr Witkowski, MD PhD
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with Type 1 Diabetes (T1D) diagnosed before age 40, insulin-dependent for at least 5 years, and have a history of severe or problematic hypoglycemia despite intensive diabetes management. Participants must not be overweight, pregnant, or planning pregnancy soon. They should also not have certain blood or immune conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Islet Transplantation
Participants receive islet cells from cadaver donors via vein to assess safety and control of blood sugar
Follow-up
Participants are monitored for safety and effectiveness after transplantation, with a focus on maintaining HbAlc <7.0% and absence of severe hypoglycemic events
What Are the Treatments Tested in This Trial?
Interventions
- Allogenic islet cells (human, U. Chicago)
- Intraportal infusion of islet cells
Allogenic islet cells (human, U. Chicago) is already approved in United States, European Union, Canada, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor