20 Participants Needed

Islet Cell Transplant for Type 1 Diabetes

LB
PW
Overseen ByPiotr Witkowski, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 - UChicago ...

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

I was diagnosed with Type 1 Diabetes before 40, need insulin for over 5 years, and have had severe low blood sugar.
I check my glucose 3+ times daily and use insulin injections or a pump under a specialist's care.
You have a history of not being able to sense when your blood sugar is low or high, or having big swings in blood sugar levels despite taking medicine for diabetes.
See 5 more

Exclusion Criteria

I have high levels of certain antibodies against transplant tissues.
Your kidney function is below a certain level.
You have had a high level of protein in your urine in the past.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Islet Transplantation

Participants receive islet cells from cadaver donors via vein to assess safety and control of blood sugar

4 weeks

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

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Allogenic islet cells (human, U. Chicago)
  • Intraportal infusion of islet cells
Trial Overview The study tests the safety of transplanting islet cells from donors into patients' livers to manage blood sugar levels in T1D without daily insulin shots. The goal is to achieve better control over blood glucose with these transplanted cells that produce insulin.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Allogenic islet cells (human, U. Chicago)Experimental Treatment2 Interventions

Allogenic islet cells (human, U. Chicago) is already approved in United States, European Union, Canada, United Kingdom for the following indications:

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Approved in United States as Islet Cell Transplantation for:
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Approved in European Union as Islet Cell Transplantation for:
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Approved in Canada as Islet Cell Transplantation for:
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Approved in United Kingdom as Islet Cell Transplantation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Published Research Related to This Trial

Islet allotransplantation has been performed for about 30 years to treat brittle type 1 diabetes, but its use is still limited to select patients due to challenges like the need for lifelong immunosuppression.
Research is ongoing to improve islet production, engraftment, and long-term function, including strategies like co-transplanting beta cell progenitors to enhance graft survival, with clinical trials anticipated in the near future.
Islet transplantation 30 years after the first transplants.Antonioli, B., Galuzzi, M.[2019]
Intraportal islet cell transplantation has become a more clinically relevant treatment for type 1 diabetes, thanks to advancements in protocols that enhance success rates and long-term function of islet grafts.
Recent improvements in islet transplantation techniques have made it a safer and simpler outpatient procedure compared to the more complex and risky whole-organ pancreas transplantation.
Use of oxygenated perfluorocarbon toward making every pancreas count.Fraker, CA., Alejandro, R., Ricordi, C.[2022]
Recent advancements in islet retrieval techniques have improved the number and purity of islets available for transplantation, allowing for renewed clinical trials in type 1 diabetes patients.
Islet transplantation, while having a lower success rate for insulin independence compared to whole pancreas transplantation, offers several advantages such as being a simpler and safer outpatient procedure, potential for cell banking, and future possibilities for xenotransplantation.
Islet transplantation.Inoue, K., Miyamoto, M.[2019]

Citations

Islet transplantation 30 years after the first transplants. [2019]
Use of oxygenated perfluorocarbon toward making every pancreas count. [2022]
Islet transplantation. [2019]
G-CSF and Exenatide Might Be Associated with Increased Long-Term Survival of Allogeneic Pancreatic Islet Grafts. [2020]
Langerhans islet preparation in cell transplantation. [2006]
Production of tissue factor by pancreatic islet cells as a trigger of detrimental thrombotic reactions in clinical islet transplantation. [2019]
[Technique of pancreatic procurement for pancreatic islet isolation]. [2009]
Quality control for clinical islet transplantation: organ procurement and preservation, the islet processing facility, isolation, and potency tests. [2021]
Clinical allogeneic and autologous islet cell transplantation: update. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Replacement of pancreatic beta cells as treatment for diabetes mellitus: a review. [2021]
Cell-based treatments for diabetes. [2008]
12.United Statespubmed.ncbi.nlm.nih.gov
C-C Chemokine Receptor Type 2-Dependent Migration of Myeloid-Derived Suppressor Cells in Protection of Islet Transplants. [2018]
[Islet cell and pancreas transplantation in diabetes: status 1996]. [2008]
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