18 Participants Needed

Myfortic for Type 1 Diabetes Islet Transplant Recipients

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rodolfo Alejandro
Must be taking: Immunosuppressive medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

RA

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

I have had at least one islet cell transplant.
Ability to provide written informed consent
I am not taking any immunosuppressive medications or have stopped them as required for islet transplantation.
See 2 more

Exclusion Criteria

You are currently using alcohol or drugs excessively.
Your liver function tests have shown consistently high levels, which means your liver may not be working properly.
You currently have an infection.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Myfortic® monotherapy for 2 years following complete islet graft loss

104 weeks

Follow-up

Participants are monitored for sensitization using panel reactive antibody (PRA) levels after Myfortic® is weaned

12 months

Treatment Details

Interventions

  • Myfortic
Trial Overview The study tests Myfortic in individuals who have experienced complete loss of their transplanted islet cells after treatment for Type 1 Diabetes. It's an open-label trial where all participants receive the drug to see if it can prevent new immune sensitivities from developing post-graft rejection.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Myfortic treatmentExperimental Treatment1 Intervention
Treatment with Myfortic

Myfortic is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Myfortic for:
  • Prevention of rejection in kidney transplant patients
🇪🇺
Approved in European Union as Myfortic for:
  • Prevention of rejection in kidney transplant patients

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rodolfo Alejandro

Lead Sponsor

Trials
10
Recruited
210+

Findings from Research

In a study of 8 Caucasian women undergoing islet cell transplantation, mycophenolic acid showed high variability in systemic exposure, indicating that individualized dosing and therapeutic monitoring may be essential for optimal treatment.
Despite some patients requiring dose reductions due to adverse effects, all participants achieved insulin independence, although 3 later experienced loss of graft function, highlighting the need for careful management of mycophenolic acid levels post-transplant.
Mycophenolate mofetil in islet cell transplant: variable pharmacokinetics but good correlation between total and unbound concentrations.Jacobson, PA., Green, KG., Hering, BJ.[2016]
Mycophenolic acid (MPA) has been shown to have a significant negative impact on pancreatic beta-cell viability and function, leading to increased apoptosis and reduced insulin secretion in both mouse and human islet cells.
The study found that MPA exposure resulted in altered islet architecture and down-regulation of key genes involved in beta-cell function, indicating its potential diabetogenic effects in the context of immunosuppressive therapy after organ transplantation.
In vitro effects of mycophenolic acid on survival, function, and gene expression of pancreatic beta-cells.Gallo, R., Natale, M., Vendrame, F., et al.[2018]
In a study of 453 adult recipients of simultaneous pancreas-kidney transplants, those receiving a high dose of mycophenolate (1000 mg three times daily) showed significantly better pancreas allograft survival compared to those on a standard dose (1000 mg twice daily).
Despite the improved pancreas graft survival with high-dose mycophenolate, there were no significant differences in rejection rates, kidney graft survival, infection rates, or overall patient survival, indicating that the higher dose specifically benefits pancreas allograft outcomes without increasing other risks.
Impact of intensive dosing of mycophenolate on pancreas allograft survival.Descourouez, JL., Jorgenson, MR., Menninga, N., et al.[2019]

References

Mycophenolate mofetil in islet cell transplant: variable pharmacokinetics but good correlation between total and unbound concentrations. [2016]
In vitro effects of mycophenolic acid on survival, function, and gene expression of pancreatic beta-cells. [2018]
Impact of intensive dosing of mycophenolate on pancreas allograft survival. [2019]
Steroid-free maintenance of islet allografts using mycophenolate mofetil and cyclosporine in the non-human primate. [2021]
Pharmacokinetics of mycophenolic acid and its glucuronidated metabolites in stable islet transplant recipients. [2016]
A 6-month, open-label, multicenter clinical study in Korean de novo renal transplant patients evaluating the efficacy, safety, and tolerance of myfortic concomitantly used with tacrolimus. [2022]
Myfortic (mycophenolate sodium) delayed-release tablets. [2017]
Age and Early Graft Function Relate With Risk-Benefit Ratio of Allogenic Islet Transplantation Under Antithymocyte Globulin-Mycophenolate Mofetil-Tacrolimus Immune Suppression. [2018]
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