A Study to Evaluate Mesenchymal Stem Cells for Reducing Anastomotic Stenosis


About this study

The purpose of this study is evaluate the safety of allogeneic adipose derived mesenchymal stem cell (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its effectiveness on improving access maturation and primary anastomotic patency.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Albert Hakaim, M.D.

Open for enrollment

Contact information:

Mauricia Buchanan R.N.

(904) 953-2077


More information


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