Myfortic for Type 1 Diabetes Islet Transplant Recipients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called Myfortic to assist individuals who have had islet transplants for type 1 diabetes but have lost transplant function. The focus is on determining if Myfortic can improve their condition by managing the immune system response. Individuals who have had at least one islet transplant and currently require immunosuppressive medication are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance transplant outcomes.
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.
Is there any evidence suggesting that Myfortic is likely to be safe for humans?
Research has shown that Myfortic has been studied in various contexts, including with kidney transplant patients. One study involving 423 kidney transplant recipients used Myfortic to help prevent organ rejection. These patients, aged 18 to 75, came from several countries, including the USA and Canada. This study provides insight into how well people tolerate Myfortic.
Generally, Myfortic is well-tolerated, but like any medication, it can cause side effects. Common side effects include stomach problems, headaches, and infections. Notably, the FDA has approved this medication for use in kidney transplant patients, indicating substantial safety information supports its use in this context.
This information may reassure potential trial participants about the safety of using Myfortic in new areas, such as islet transplantation for type 1 diabetes.12345Why are researchers excited about this trial?
Unlike the standard treatments for Type 1 diabetes in islet transplant recipients, Myfortic offers a new approach by focusing on immune system modulation. Most current therapies aim to manage blood sugar levels or suppress the immune system broadly, but Myfortic specifically targets the immune pathways involved in transplant rejection. This precision could lead to fewer side effects and better outcomes for patients, making it an exciting option for researchers looking to improve transplant success rates.
What evidence suggests that Myfortic might be an effective treatment for Type 1 Diabetes?
Research has shown that Myfortic, which contains mycophenolic acid, plays a crucial role in transplants by preventing the immune system from attacking new cells. Previous studies have found that islet transplants in people with type 1 diabetes can lead to insulin independence, eliminating the need for insulin shots. In some cases, all patients became insulin independent, and many maintained this status for an extended period. This trial will evaluate Myfortic's role in supporting islet transplants, potentially improving blood sugar control and reducing episodes of low blood sugar in type 1 diabetes.24678
Who Is on the Research Team?
Rodolfo Alejandro, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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