AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Recruiting · NCT04392206 · Interventional (participants receive a specific treatment) · Lead sponsor: Houssam Farres, M.D.
View the official record on ClinicalTrials.gov →Interventions studied
Adipose Derived Mesenchymal Stem Cells
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Mayo Clinic in Florida - Jacksonville, Florida, United States