Islet Allografts for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the long-term safety and effectiveness of islet cell transplants for individuals who have already undergone the procedure. Islet cells aid in insulin production, essential for diabetes management. The trial evaluates the ongoing effectiveness of these transplants and whether recipients continue to benefit. Individuals who have had a successful islet cell transplant in a previous study and are still taking medication to prevent rejection may be suitable candidates. As a Phase 4 trial, this research highlights that the treatment is already FDA-approved and effective, aiming to understand its benefits for more patients.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications, but it does require you to continue taking immunosuppressive medications if you have a functioning islet graft. It's best to discuss your specific medications with the trial team.
What is the safety track record for functional islet allografts?
Studies have shown that transplanting islet cells can safely treat diabetes. Research indicates that patients generally tolerate these donor cells well. However, the effectiveness of these cells may require enhancement for improved results.
One study examined the safety of islet transplantation over five years. It found that while many patients experienced positive outcomes, some faced issues due to medications needed to prevent transplant rejection. These medications can cause side effects, so doctors closely monitor patients taking them.
Overall, the safety data suggest that islet transplantation has been manageable for most patients, though ongoing monitoring and improvements remain essential.12345Why are researchers excited about this trial?
Functional Islet Allografts are unique because they offer a potential new approach for treating diabetes by transplanting healthy islet cells directly into patients. Unlike traditional treatments that rely on insulin injections or pumps, these allografts aim to restore the body's natural ability to produce insulin by replacing damaged or non-functioning islet cells. Researchers are excited about this therapy because it targets the root cause of diabetes, offering hope for a more permanent solution and reducing the need for constant blood sugar monitoring and insulin administration.
What evidence suggests that functional islet allografts might be an effective treatment for diabetes?
Research shows that islet cell transplants, which use healthy cells from a donor, yield promising results for people with diabetes. Studies report that up to 86% of these transplants function after one year, and 65% continue to work for five years. Even after ten years, about 47% remain effective. Participants who received these transplants experienced fewer episodes of dangerously low blood sugar. These findings suggest that islet cell transplantation can effectively manage diabetes over the long term.678910
Who Is on the Research Team?
Rodolfo Alejandro, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Follow-up
Participants are monitored for safety and efficacy of islet allograft function
Maintenance
Participants receive maintenance immunosuppressive medications
What Are the Treatments Tested in This Trial?
Interventions
- Functional Islet Allografts
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rodolfo Alejandro
Lead Sponsor
Citations
Relation between primary graft function and 5-year ...
Long-term results from several prospective and retrospective cohort studies, showed 48–78% graft survival (defined as C-peptide ≥ 0.3 ng/mL3), up to twenty ...
2.
diabetesjournals.org
diabetesjournals.org/diabetes/article/74/5/685/158079/Cell-Benchmarks-Defining-Predictive-Outcomes-inβ-Cell Benchmarks: Defining Predictive Outcomes in Islet ...
The current study demonstrates diminished islet graft function in recipients at 3 years with this induction-immunosuppression regimen (4).
Long-term outcomes of pancreatic islet transplantation ...
Kaplan–Meier estimates indicated graft survival rates of 86% at 1 year, 65% at 5 years, 47% at 10 years, 47% at 15 years, and 40% at 20 years.
The Current Status of Allogenic Islet Cell Transplantation
We review data on long-term outcomes and the ongoing challenges of allogenic islet cell and stem cell-derived islet cell transplant.
Factors associated with favourable 5 year outcomes in islet ...
Islet transplantation meeting 4CFF protected 95% from SHEs at 5 years after the last islet infusion and exerted a large and significant benefit on glycaemic ...
Twelfth Allograft Report
We are pleased to present this Twelfth Allograft Report (infusions as of Dec 2023, follow-up as of March 2025) including data from the great ...
Safety and Viability of Microencapsulated Human Islets ...
While allografting of encapsulated human islets is safe, efficacy of the cells needs to improve for the therapy to make an impact on the clinical scene.
Long Term Follow up of Recipients of Functional Islet ...
The purpose of this protocol is to collect additional follow-up for safety and efficacy from subjects with graft function after their completion in their parent ...
9.
diabetesjournals.org
diabetesjournals.org/care/article/38/9/1714/37304/Five-Year-Metabolic-Functional-and-Safety-ResultsFive-Year Metabolic, Functional, and Safety Results of ...
The purpose of the current study was to describe the 5-year outcome and safety profile of islet transplantation in the GRAGIL-1c and GRAGIL-2 ...
Pancreatic Islet Transplantation in Humans - Oxford Academic
Safety data using these nongenetically ... Purified canine islet autografts—functional outcome as influenced by islet number and implantation site.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.