What side effects are associated with this type of intervention?

Common treatments for diabetes, particularly those similar to islet cell transplantation, include immunosuppressive therapies and glucagon-like peptide-1 (GLP-1) receptor agonists. Immunosuppressive therapies, used to prevent rejection of transplanted islet cells, can lead to side effects such as increased risk of infections, nephrotoxicity, and gastrointestinal issues. GLP-1 receptor agonists, which help improve islet graft function and survival, are associated with side effects like nausea, vomiting, diarrhea, and potential risks of pancreatitis and pancreatic cancer. Patients should discuss these potential side effects with their healthcare provider to make informed decisions about their treatment options.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetes, including insulin therapy, oral hypoglycemic agents, and more recently, advanced therapies like GLP-1 receptor agonists and SGLT2 inhibitors. These treatments primarily manage blood glucose levels and reduce cardiovascular risks. Islet cell transplantation, which aims to restore insulin production by transplanting functional islet cells, is currently under clinical investigation and has shown promise in reversing hyperglycemia and reducing insulin dependency in Type 1 Diabetes Mellitus patients. This approach represents a significant advancement towards potentially curative therapies for diabetes.

What other types of research exist?

Promising novel alternatives to Islet Cell Transplantation for diabetes patients include: 1) Stem cell therapy, particularly using induced pluripotent stem cells (iPSCs) to generate insulin-producing beta cells. 2) Immunomodulatory treatments, such as the use of anti-CD3 antibodies or other agents to preserve beta cell function and prevent autoimmune destruction. 3) Gene therapy approaches to correct genetic defects and promote beta cell regeneration. 4) Advanced drug therapies like GLP-1 receptor agonists and DPP-4 inhibitors to enhance beta cell function and survival.

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Cell Therapy

Islet Transplant for Type 1 Diabetes

Phase 2

Waitlist Available

Led By Camillo Ricordi, M.D.

Research Sponsored by Rodolfo Alejandro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Progressive complications of type 1 diabetes mellitus

Patients with type 1 diabetes mellitus for more than 5 years duration

Must not have

Insulin requirement >1u/kg/day and any condition or any circumstance that makes it unsafe to undergo an islet cell transplant

Previous/concurrent organ transplantation (except previous unsuccessful islet cell transplant)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial involves transplanting insulin-producing cells into patients with Type 1 Diabetes to help them manage their blood sugar levels without needing insulin injections. The trial also tests medications to protect these new cells from the immune system and improve their function and survival. One of these medications has been studied for its potential to improve beta-cell function in long-standing type 1 diabetes.

Who is the study for?

This trial is for adults aged 18-65 with Type 1 Diabetes Mellitus, BMI ≤26, experiencing severe hypoglycemia unawareness or poor diabetes control despite intensive insulin therapy. Candidates must have had diabetes for over 5 years and show progressive complications. Excluded are those with certain blood markers, untreated eye issues, kidney dysfunction, high insulin requirements or lipid levels, specific infections including HIV/HCV/EBV, history of malignancy (except some skin cancers), unstable heart conditions, pregnancy/breastfeeding without proper contraception use, recent substance abuse/smoking.

What is being tested?

The study tests whether transplanting islet cells can reverse the need for insulin in Type 1 Diabetes patients while avoiding steroid-based immunosuppression. It also examines if this procedure prevents severe low blood sugar episodes and improves long-term health outcomes related to diabetes complications. The effects of infliximab and etanercept on early islet survival and exenatide on graft function/survival are being studied as well.

What are the potential side effects?

Potential side effects may include immune system reactions due to the transplanted cells or medications like infliximab and etanercept used to prevent rejection; these could lead to inflammation or infection risks. Exenatide might cause digestive issues such as nausea or decreased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My type 1 diabetes is getting worse.

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I have had type 1 diabetes for over 5 years.

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I have had low blood sugar episodes without noticing.

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My diabetes is not well-controlled despite using insulin regularly.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need more than 1 unit of insulin per kg daily and it's unsafe for me to have an islet cell transplant.

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I have had an organ transplant, but not an islet cell transplant.

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I have or had cancer, but not skin cancer.

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I do not have any active infections.

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I have an active stomach ulcer, gallstones, a blood vessel tumor, or high blood pressure in the liver.

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I have a positive TB skin test without completed preventive treatment.

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My heart condition is not stable.

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I have diabetic eye disease that hasn't been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: Islet transplantationExperimental Treatment1 Intervention

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes include insulin therapy, immunosuppressive therapies, and islet cell transplantation. Insulin therapy involves administering insulin to manage blood glucose levels, crucial for patients whose bodies do not produce enough insulin. Immunosuppressive therapies, such as those used in islet cell transplantation, help prevent the immune system from attacking transplanted islet cells, which are introduced to restore insulin production. Islet cell transplantation specifically aims to replace damaged pancreatic cells with functional ones, potentially reducing or eliminating the need for exogenous insulin. These treatments are vital as they help maintain blood glucose control, reduce complications, and improve the quality of life for diabetes patients.

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Who is running the clinical trial?

Rodolfo AlejandroLead Sponsor

9 Previous Clinical Trials

188 Total Patients Enrolled

Health Resources and Services Administration (HRSA)FED

85 Previous Clinical Trials

151,627 Total Patients Enrolled

1 Trials studying Diabetes

45 Patients Enrolled for Diabetes

National Institutes of Health (NIH)NIH

2,765 Previous Clinical Trials

8,133,471 Total Patients Enrolled

25 Trials studying Diabetes

64,177 Patients Enrolled for Diabetes

Media Library

islets (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00306098 — Phase 2

Diabetes Research Study Groups: Islet transplantation

Diabetes Clinical Trial 2023: islets Highlights & Side Effects. Trial Name: NCT00306098 — Phase 2

islets (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00306098 — Phase 2

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