Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02808208|
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease (ESRD) Vascular Access Complication||Biological: Adipose Derived Mesenchymal Stem Cells (AMSC)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure|
|Actual Study Start Date :||June 7, 2017|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
Experimental: Group 1 AMSC Treatment
Patients have tissue biopsy and Adipose Derived Mesenchymal Stem Cells (AMSC) treatment.
Biological: Adipose Derived Mesenchymal Stem Cells (AMSC)
This group will receive Autologous stem cells derived from own fat biopsy.
No Intervention: Group 2 No Treatment
Patients receive standard of care.
- Hemodialysis outflow vein diameter [ Time Frame: Baseline to 12 months after AVF creation ]Diameter of outflow vein by ultrasound
- Hemodialysis AVF Blood flow [ Time Frame: Baseline to 12 months after AVF creation ]blood flow by ultrasound or dialysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808208
|Contact: Lori Johnson||507-266-0899||Johnson.Lori@mayo.edu|
|Contact: Matthew Hoplin||507-293-0947||Hoplin.Matthew@mayo.edu|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Sanjay Misra, M.D.||Mayo Clinic|