Using stem cells to improve blood vessel access for dialysis patients
Official title: A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Run by Mayo Clinic · NCT04392206 · Data updated 2026-11-12
This study is testing whether using stem cells can help improve blood vessel access for people with kidney failure who need dialysis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Status | Recruiting |
| Started | May 15, 2020 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT04392206 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 85 who are scheduled for upper extremity AV fistula creation and have suitable anatomy.
✕Probably not a fit
Patients with recent malignancy, immunodeficiency, or a history of significant thrombotic events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and efficacy of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) in patients undergoing the creation of arteriovenous fistulas for hemodialysis. The study focuses on improving access maturation and ensuring primary anastomotic patency in patients with end-stage renal disease. Participants will be monitored for their ability to communicate and comply with study procedures, and the trial aims to assess the potential benefits of stem cell therapy in this context.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of dialysis access procedures and improve patient outcomes.
How similar studies have gone: While the use of stem cells in vascular procedures is an emerging field, this specific application is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed. Exclusion Criteria: * 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 DVTs or other spontaneous intravascular thrombotic events * Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF * History of failed organ transplant on immunosuppression. * Subjects with known active infection (infection which is being treated)
Where it's running
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Mayo Clinic in Florida
Jacksonville, Florida, United States Recruiting
Study contacts
- Principal investigator: Houssam Farres, MD — Mayo Clinic
- Study coordinator: Reagan Dukes
- Email: Dukes.Reagan@mayo.edu
- Phone: (904) 953-2077
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.