AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
ConditionEnd Stage Renal Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHoussam Farres, M.D.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adipose Derived Mesenchymal Stem Cells
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Houssam Farres, M.D.
Lead sponsor
Mayo Clinic
Sponsor institution
Source ClinicalTrials.gov