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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with Type 1 diabetes to determine if it can manage blood sugar levels more effectively. The treatment involves transplanting islets of Langerhans, which are groups of cells that regulate blood sugar. The trial seeks participants who have had Type 1 diabetes for over five years and have experienced severe low blood sugar episodes despite careful insulin management. Participants will receive up to three transplants to assess the safety and effectiveness of this approach. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking diabetes therapy.

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 there any evidence suggesting that islet transplantation is likely to be safe for humans?

Research shows that islet transplantation is generally safe. Over ten years of studies indicate it helps people with Type 1 diabetes control their blood sugar. This treatment uses cells from a donor's pancreas, known as islets, to help the body manage insulin better.

Previous studies found that the procedure is well-tolerated with few serious side effects. Recipients of the transplants reported better blood sugar control and needed fewer insulin shots.

Overall, evidence supports that pancreatic islet cell transplantation is safe and effective for treating Type 1 diabetes. However, like any medical procedure, some risks may exist, so discussing these with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 1 diabetes?

Unlike the standard treatments for Type 1 Diabetes, which often involve insulin injections or pumps, islet transplantation offers a novel approach. This treatment uses allogeneic human islets of Langerhans, which are clusters of cells from the pancreas that produce insulin naturally. Researchers are excited because this method could potentially restore the body's ability to regulate blood sugar without the need for constant insulin administration. This could mean a more natural and long-lasting solution for managing Type 1 Diabetes, potentially reducing the burden of daily management and improving quality of life.

What evidence suggests that islet transplantation could be an effective treatment for Type 1 diabetes?

Research has shown that islet transplantation, which participants in this trial will receive, can help people with Type 1 diabetes. In earlier studies, up to 44% of patients no longer needed insulin shots after receiving transplanted islets. Long-term results indicated that this treatment helped control blood sugar levels and reduced episodes of dangerously low blood sugar. Specifically, 91% of recipients did not experience severe low blood sugar episodes one year after the procedure. These findings suggest that islet transplantation can improve life for people with Type 1 diabetes. ^{1 6 7 8 9}

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

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11906537/

Islet Cell Replacement and Regeneration for Type 1 Diabetes The international trial of the Edmonton protocol for islet transplantation demonstrated that insulin independence was achievable in 44% of T1D ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522088049

Ten-year outcomes of islet transplantation in patients with ... With a 10-year follow-up in a multicentric network, islet transplantation provided sustained improvement of glycemic control and was efficient to prevent ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22486926/

Islet cell transplantation in type 1 diabetes: an analysis of ... Ninety-one percent of all recipients were free of severe hypoglycemic episodes at 1 year. Furthermore, the KM survival estimates showed that 91%, 85% and 80% of ...

4. diabetesjournals.org diabetesjournals.org/diabetes/article/74/7/1068/158190/Advances-in-Cell-Replacement-Therapies-for

Advances in Cell Replacement Therapies for Diabetes In the largest multicenter trials of ITA and IAK in the U.S., insulin independence was additionally achieved in 74% of islet transplant ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01909245

NCT01909245 | Islet Cell Transplant for Type 1 Diabetes In previous research studies, islet transplantation has been successful in reducing low blood sugar episodes, improving overall blood sugar control, and in some ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33961335/

Ten-year outcomes of islet transplantation in patients with ... With a 10-year follow-up in a multicentric network, islet transplantation provided sustained improvement of glycemic control and was efficient to prevent severe ...

7. diabetesjournals.org diabetesjournals.org/care/article/48/6/1007/158141/Impact-of-Islet-Transplantation-on-Diabetes

Impact of Islet Transplantation on Diabetes Complications and ... Ten-year outcomes of islet transplantation in patients with type 1 diabetes: data from the Swiss-French GRAGIL Network . Am J Transplant.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00679042

NCT00679042 | Islet Transplantation in Type 1 Diabetic ... The safety of islet transplantation depends primarily on the incidence of serious and unexpected complications or adverse events and the ability of the cell ...

9. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1391504/full

Pancreatic islet transplantation: current advances and ... In conclusion, the latest research and clinical data unequivocally support the safety and efficacy of pancreatic islet cell transplantation in T1DM treatment.