21 Participants Needed

Islet Transplantation for Type 1 Diabetes

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is evaluating whether islet transplantation is safe and effective for people with type 1 diabetes.

Will I have to stop taking my current medications?

The trial requires that participants stop taking any antidiabetic medication other than insulin at least 4 weeks before enrolling. If you are on other medications, it's best to discuss with the trial team to see if they are allowed.

Is islet transplantation for type 1 diabetes safe for humans?

Islet transplantation has been studied for safety, with some adverse events reported, such as elevated liver enzymes, infections, and bleeding, mostly related to the transplant procedure and the drugs used to prevent rejection. These events were generally resolved without long-term effects, but the procedure still requires careful monitoring and improvements in safety protocols.12345

How is the islet transplantation treatment different from other treatments for type 1 diabetes?

Islet transplantation involves implanting insulin-producing cells from a donor into a person with type 1 diabetes, offering a more natural way to regulate blood sugar compared to regular insulin injections. Unlike whole pancreas transplants, it is a simpler and safer procedure, though it still requires immunosuppressive drugs to prevent rejection.678910

What data supports the effectiveness of the treatment Islets of Langerhans for Type 1 Diabetes?

Islet transplantation, which involves replacing insulin-producing cells, has shown promise in controlling blood sugar levels in people with Type 1 diabetes. Recent studies highlight improvements in insulin independence and better control of blood sugar, reducing severe low blood sugar episodes and improving quality of life.611121314

Who Is on the Research Team?

JO

Jose Oberholzer, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for Type 1 diabetes patients who've had the disease for over 5 years and experienced severe hypoglycemia or have reduced hypoglycemia awareness. Exclusions include those with pancreatitis, kidney issues, substance abuse, certain infections like hepatitis or HIV, pregnancy/breastfeeding without contraception use, some heart conditions, and other specific health concerns.

Inclusion Criteria

I have had Type 1 diabetes for over 5 years and often don't notice when my blood sugar is low.
I have had Type 1 diabetes for over 5 years and experienced a severe low blood sugar episode in the last 3 years.

Exclusion Criteria

You have a large amount of protein in your urine.
My family has a history of MEN2 or MCT.
Inability to provide informed consent
See 34 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Islet Transplantation

Participants receive up to 3 allogeneic pancreatic islet transplants

Varies per participant
1-3 visits for transplantation

Follow-up

Participants are monitored for safety and effectiveness after each transplant

52 weeks after the final islet transplantation
Regular visits every two months

Long-term Follow-up

Participants may enroll for additional follow-up to evaluate islet function and manage immunosuppressive drug levels

5 to 10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Islets of Langerhans
Trial Overview The trial tests the safety and effectiveness of transplanting islet cells to control blood sugar in Type 1 diabetes using the UIC protocol. This follows a successful earlier phase where this method showed promise without using steroids for immunosuppression.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.

Find a Clinic Near You

Who Is Running the Clinical Trial?

CellTrans Inc.

Lead Sponsor

Trials
2
Recruited
20+

Published Research Related to This Trial

Islet transplantation outcomes for type 1 diabetes have improved over time, with insulin independence rates increasing from 27% in 1999-2002 to 44% in 2007-2010, indicating enhanced efficacy of the procedure.
Safety outcomes also improved, as evidenced by a lower rate of islet reinfusion (48% in 2007-2010 compared to 60-65% in earlier years) and a reduction in adverse events, suggesting a more favorable risk profile for recent transplant recipients.
Improvement in outcomes of clinical islet transplantation: 1999-2010.Barton, FB., Rickels, MR., Alejandro, R., et al.[2022]
Islet transplantation is a promising alternative treatment for type 1 diabetes, which affects an estimated 300,000 to 500,000 people in the U.S., potentially improving health outcomes compared to traditional insulin therapy.
The North American Collaborative Islet Transplant Registry (CITR) is collecting and analyzing data from islet transplants across North America to enhance the safety and efficacy of these procedures, with participation from over 22 transplant centers to identify key factors influencing patient and graft survival.
NIH-Supported National Islet Transplantation Registry.Close, N., Anand, R., Hering, B., et al.[2019]
In a study of 325 adult recipients of islet transplants, 23% achieved insulin independence for at least 2 weeks three years after their first infusion, indicating that islet transplantation can significantly improve metabolic control in Type 1 diabetes.
The use of immunosuppressive protocols with daclizumab or etanercept was associated with higher rates of insulin independence and lower rates of function loss, suggesting that these approaches enhance the efficacy of islet transplantation.
2008 Update from the Collaborative Islet Transplant Registry.Alejandro, R., Barton, FB., Hering, BJ., et al.[2022]

Citations

[Treatment of insulin-dependent diabetes: new therapeutics. Cellular replacement: facts and perspectives]. [2011]
Islet cell transplantation: the future? [2019]
Overcoming the challenges now limiting islet transplantation: a sequential, integrated approach. [2021]
Clinical pancreatic islet transplantation. [2022]
Progress in islet transplantation in patients with type 1 diabetes mellitus. [2022]
Improvement in outcomes of clinical islet transplantation: 1999-2010. [2022]
Adverse events in clinical islet transplantation: one institutional experience. [2021]
NIH-Supported National Islet Transplantation Registry. [2019]
Strategic opportunities in clinical islet transplantation. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
2008 Update from the Collaborative Islet Transplant Registry. [2022]
[Islet cell and pancreas transplantation in diabetes: status 1996]. [2008]
[Islet of Langerhans transplantation]. [2009]
Islet cell transplantation in diabetes mellitus--from bench to bedside. [2005]
Human islet allotransplantation: world experience and current status. [2018]
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