Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.

Inclusion Criteria

• Patient between 18 and 85 years old
• Patient currently on hemodialysis or pre-dialysis and planned 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

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
• Pregnancy or breast feeding
• 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
• Employees of the sponsor or patients who are employees or relatives of the investigator
• History of failed organ transplant on immunosuppression