Actively Recruiting
A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Led by Houssam Farres, M.D. · Updated on 2025-08-12
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) during the creation of hemodialysis arteriovenous fistulas and arterial bypasses in patients with End Stage Renal Disease (ESRD). This Phase I, open-label study aims to assess whether AMSCs can improve the maturation of the access site and maintain primary anastomotic patency, which is vital for successful dialysis treatment. Participants diagnosed with ESRD and currently on hemodialysis who are scheduled for a new upper extremity arteriovenous fistula will receive an infusion of AMSCs. The stem cell dose will be customized based on each subject's vascular anatomy, determined by ultrasound measurements, with approximately 3-5 million cells delivered in 5 ml of Ringer Lactate solution. This treatment will be given during the surgical procedure to create the fistula. During the study, participants will be monitored for treatment-related adverse events over a 12-month period to evaluate safety. Researchers will collect clinical data and perform assessments to track access maturation and patency. Participants must be able to communicate with study staff and comply with all study procedures. The total study duration extends to at least 12 months of follow-up after the treatment.
CONDITIONS
Brief Title
AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient between 18 and 85 years old
- Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy
- Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
- Life expectancy of at least 24 months
- If female, must be post-menopausal or not able to have children, with documentation or pregnancy test if needed
You will not qualify if you...
- Malignancy or treatment for malignancy within the previous 6 months
- Immunodeficiency including AIDS / HIV or active autoimmune disease
- Documented hypercoagulable state or history of 2 or more deep vein thromboses or other spontaneous intravascular thrombotic events
- Treatment with any investigational drug or device within 60 days prior to study entry or any condition that would interfere with safety or efficacy evaluation
- History of failed organ transplant on immunosuppression
- Known active infection being treated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive a tailored dose of allogeneic adipose derived mesenchymal stem cells to reduce anastomotic stenosis in their arteriovenous fistula.
Multiple visits for treatment and monitoring over 12 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
R
Reagan Dukes
M
Mauricia Buchanan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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