Status:
RECRUITING
AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Lead Sponsor:
Houssam Farres, M.D.
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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 improvi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04392206
Start Date
May 15 2020
End Date
June 1 2027
Last Update
August 12 2025
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224