Phase 1 Study of Stem Cell Therapy to Improve Arteriovenous Fistulas for Hemodialysis in Adults with End Stage Renal Disease

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 adults with End Stage Renal Disease ESRD. This Phase 1 study aims to see if AMSC treatment can improve access maturation and maintain the primary anastomotic patency needed for dialysis. The study focuses on adults between 18 and 85 years old who require new upper extremity arteriovenous fistulas. Participants will receive a tailored dose of AMSCs based on their vascular anatomy, with approximately 3 to 5 million cells delivered in a 5 ml Ringer Lactate solution. This treatment is given during the surgical creation of the fistula. The study is a single-group, open-label trial with no placebo or comparator group. The dosing is customized using ultrasound to determine the best delivery for each participant. During the study, participants will be monitored for safety over 12 months, specifically tracking any treatment-related adverse events. Researchers will assess how well the fistula matures and remains open after receiving the stem cell treatment. Participants must be able to communicate effectively, give informed consent, and comply with study procedures. The total study duration extends up to June 2027, with primary outcome data expected by December 2026.

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses