Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
End Stage Renal Disease (ESRD), Vascular Access Complication
About this trial
This is an interventional treatment trial for End Stage Renal Disease (ESRD)
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
No Intervention
Experimental
Experimental
Placebo Comparator
Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula
AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula
Placebo treatment in brachiobasilic arteriovenous fistula
Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)
Patients receive standard of care.
Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF
Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF
Subjects will receive placebo at first and second stage of BBF