Overview

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Status:
Recruiting
Trial end date:
2026-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Albert Hakaim
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)