Islet Transplantation for Type 1 Diabetes

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: CellTrans Inc.

Must not be taking: Antidepressants, Anticoagulants, Steroids, others

Disqualifiers: Cardiac disease, Substance abuse, Infections, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

21 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{6 11 12 13 14}

Who Is on the Research Team?

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

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?

Group I: Treatment Experimental Treatment 1 Intervention

All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2008 Update from the Collaborative Islet Transplant Registry. Alejandro, R., Barton, FB., Hering, BJ., et al.[2022]

Pancreas and islet transplantation are the only treatments for type 1 diabetes that can lead to insulin independence and stable blood sugar levels, but they require immunosuppressive therapy, which carries risks.

Recent advancements suggest that islet transplantation could be modified to reduce immunosuppression needs, potentially expanding its use to non-uremic type 1 diabetics, including children, while also improving quality of life and delaying complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Islet cell and pancreas transplantation in diabetes: status 1996]. Bretzel, RG.[2008]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment of insulin-dependent diabetes: new therapeutics. Cellular replacement: facts and perspectives]. [2011]

2. Germany pubmed.ncbi.nlm.nih.gov

Islet cell transplantation: the future? [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Overcoming the challenges now limiting islet transplantation: a sequential, integrated approach. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Clinical pancreatic islet transplantation. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Progress in islet transplantation in patients with type 1 diabetes mellitus. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Improvement in outcomes of clinical islet transplantation: 1999-2010. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events in clinical islet transplantation: one institutional experience. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

NIH-Supported National Islet Transplantation Registry. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Strategic opportunities in clinical islet transplantation. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

2008 Update from the Collaborative Islet Transplant Registry. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Islet cell and pancreas transplantation in diabetes: status 1996]. [2008]

12. France pubmed.ncbi.nlm.nih.gov

[Islet of Langerhans transplantation]. [2009]

13. Germany pubmed.ncbi.nlm.nih.gov

Islet cell transplantation in diabetes mellitus--from bench to bedside. [2005]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Human islet allotransplantation: world experience and current status. [2018]