NCT04392206 AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
| NCT ID | NCT04392206 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Houssam Farres, M.D. |
| Condition | End Stage Renal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2020-05-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2020-05-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.
Eligibility 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)
Contact & Investigator
Houssam Farres, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04392206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying End Stage Renal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04392206 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04392206 currently recruiting?
Yes, NCT04392206 is actively recruiting participants. Contact the research team at Dukes.Reagan@mayo.edu for enrollment information.
Where is the NCT04392206 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT04392206 clinical trial?
NCT04392206 is sponsored by Houssam Farres, M.D.. The principal investigator is Houssam Farres, MD at Mayo Clinic. The trial plans to enroll 15 participants.