60 Participants Needed

Islet Transplant Surveillance for Type 1 Diabetes

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rodolfo Alejandro
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines individuals who have undergone a specific type of cell transplant known as an islet transplant, particularly after it ceases to function. The goal is to understand long-term outcomes after the transplanted cells lose their function. It focuses on individuals who have received an islet transplant without any other organ transplants. Participants should have a history of this transplant and be able to adhere to the study's guidelines. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that could enhance future transplant outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that islet transplantation, which involves taking medication to prevent organ rejection, remains safe over the long term. In one study, 92% of participants were still alive after an average of 13 years. Another study found that recipients had more than a 93% chance of surviving for at least five years. However, some research suggests a higher risk of heart attack for certain individuals, though not all studies observe this. Overall, islet transplantation appears well-tolerated, but discussing potential risks with a healthcare provider is important.12345

Why are researchers excited about this trial?

Unlike the standard of care for individuals with complete islet graft loss, which often involves insulin injections to manage blood sugar levels, islet transplantation offers a unique approach by aiming to restore the body's ability to produce insulin naturally. This treatment involves transplanting insulin-producing cells, known as islets, into the patient's liver, where they can begin to produce insulin once again. Researchers are excited because this approach could potentially reduce or eliminate the need for continuous insulin therapy, offering a more natural and possibly long-lasting solution to managing blood sugar levels. Additionally, islet transplantation could improve quality of life and reduce complications associated with diabetes.

What evidence suggests that islet transplant could be effective for islet graft loss?

Studies have shown that islet transplantation can help people with Type 1 diabetes better control their blood sugar. One study found that, after 10 years, this procedure helps maintain stable blood sugar levels over time. Another study demonstrated that the transplanted cells had an 86% survival rate after 1 year and 65% after 5 years. Additionally, more than 90% of patients who received multiple transplants avoided severe low blood sugar episodes after one year. These findings suggest that islet transplants can be effective for long-term diabetes management.56789

Who Is on the Research Team?

RA

Rodolfo Alejandro, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

1. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Discontinuation of maintenance immunosuppression and monitoring for allosensitization

10 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Islet Transplant

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rodolfo Alejandro

Lead Sponsor

Trials
10
Recruited
210+

Citations

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 ...
The Current Status of Allogenic Islet Cell TransplantationWe review data on long-term outcomes and the ongoing challenges of allogenic islet cell and stem cell-derived islet cell transplant.
β-Cell Benchmarks: Defining Predictive Outcomes in Islet ...The study underscores the pivotal role that the functional β-cell mass plays in predicting sustained insulin independence and glycemic control ...
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.
Islet Cell Transplantation in Type 1 Diabetes: An Analysis ...Absence of SHE: For this endpoint, the success rates at 1 year in patients with one, two and three transplants were 81%, 93% and 98%, respectively (Table 4).
Can Islet Transplantation Possibly Reduce Mortality in ...The data indicated that islet and kidney recipients had a >93% and >90% chance of survival at 5 and 10 years, respectively. This compared to a ~ ...
7.citregistry.orgcitregistry.org/welcome
Welcome | CITRThe mission of the Collaborative Islet Transplant Registry (CITR) is to expedite progress and promote safety in islet/beta cell transplantation.
Pancreatic islet transplantation: current advances and ...This study showed that despite the need for chronic immunosuppression therapy, islet cell transplantation demonstrated good long-term safety. In this study, ...
Impact of Islet Transplantation on Diabetes Complications and ...However, the data from our study suggest an increased risk of myocardial infarction in the IAK population. This finding contradicts several ...
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