AMSC for Fistula in Hemodialysis Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking investigational drugs or have certain conditions, you may not be eligible to participate.
Is the use of autologous adipose-derived mesenchymal stem cells (AMSCs) safe for humans?
Studies have shown that autologous adipose-derived mesenchymal stem cells (AMSCs) are generally safe for use in humans, with no serious adverse events reported in various clinical applications, including arthritis and complex perianal fistulas. Preclinical studies in animals also support their safety, showing no harmful effects on joint tissues.12345
How is the treatment with autologous adipose-derived mesenchymal stem cells (AMSC) for fistula in hemodialysis patients different from other treatments?
What data supports the effectiveness of the treatment Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) for fistulas in hemodialysis patients?
Research shows that adipose-derived stem cells have been effective in treating complex perianal fistulas, suggesting potential benefits for similar conditions. These stem cells have been used successfully in other trials to promote healing in fistula cases, indicating they might help in hemodialysis patients as well.367910
Who Is on the Research Team?
Sanjay Misra, M.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 on hemodialysis or pre-dialysis needing an upper extremity AV fistula, who can consent and follow the study plan. They should expect to live at least two more years. It's not for sponsor employees, pregnant/breastfeeding individuals, recent investigational drug/device users, cancer patients within six months, those with immune/autoimmune diseases or a history of clotting issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) during the surgical creation of arteriovenous fistula
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor