Myfortic for Type 1 Diabetes Islet Transplant Recipients
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that participants may be on immunosuppressive medications or may need to stop them as per the current protocol of islet transplantation.
What evidence supports the effectiveness of the drug Myfortic for islet transplant recipients with Type 1 Diabetes?
Research shows that mycophenolic acid, a component of Myfortic, is used in islet cell transplants and has been associated with insulin independence in patients, although some experienced loss of graft function later. Additionally, mycophenolic acid is considered less toxic compared to other immunosuppressive drugs, which may support its use in maintaining islet transplants.12345
Is Myfortic safe for humans?
Myfortic (mycophenolic acid) has been studied in various transplant patients, showing some side effects like gastrointestinal discomfort and the need for dose adjustments. In islet transplant recipients, some patients required dose reductions due to adverse effects, and in vitro studies suggest it may affect pancreatic cell function.12456
How is the drug Myfortic unique for islet transplant recipients with Type 1 Diabetes?
Myfortic is a delayed-release formulation of mycophenolic acid designed to reduce gastrointestinal side effects, which can be a common issue with similar drugs. This makes it potentially more tolerable for patients undergoing islet transplantation, where managing side effects is crucial for maintaining overall health and treatment adherence.15678
What is the purpose of this trial?
This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.
Research Team
Rodolfo Alejandro, MD
Principal Investigator
University of Miami
Eligibility Criteria
This trial is for adults aged 18-70 with Type 1 Diabetes who've had at least one islet transplant but now have complete graft loss. They must be on or able to stop immunosuppressants, mentally stable, and not pregnant or breastfeeding. Exclusions include a history of severe diseases like cancer (except certain skin cancers), heart disease, untreated high cholesterol, obesity, hypertension, liver issues, and active infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Myfortic® monotherapy for 2 years following complete islet graft loss
Follow-up
Participants are monitored for sensitization using panel reactive antibody (PRA) levels after Myfortic® is weaned
Treatment Details
Interventions
- Myfortic
Myfortic is already approved in United States, European Union for the following indications:
- Prevention of rejection in kidney transplant patients
- Prevention of rejection in kidney transplant patients
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Who Is Running the Clinical Trial?
Rodolfo Alejandro
Lead Sponsor