Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
NCT ID: NCT02808208
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
74 participants
INTERVENTIONAL
2017-06-07
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) 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)
Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.
No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Patients receive standard of care.
No interventions assigned to this group
Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula
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
Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.
AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula
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
Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
Two topical applications of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period at stage one and two of fistula surgery
Placebo treatment in brachiobasilic arteriovenous fistula
Subjects will receive placebo at first and second stage of BBF
Placebo
5-mL of Lactated Ringers solution topical application to the surface of the outflow vein (right next to the fistula) over a five-minute period.
Interventions
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Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.
Placebo
5-mL of Lactated Ringers solution topical application to the surface of the outflow vein (right next to the fistula) over a five-minute period.
Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
Two topical applications of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period at stage one and two of fistula surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Sanjay Misra, M.D.
M.D.
Principal Investigators
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Sanjay Misra, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Piryani AK, Kilari S, Takahashi E, DeMartino RR, Mandrekar J, Dietz AB, Misra S. Rationale and Trial Design of MesEnchymal Stem Cell Trial in Preventing Venous Stenosis of Hemodialysis Vascular Access Arteriovenous Fistula (MEST AVF Trial). Kidney360. 2021 Sep 28;2(12):1945-1952. doi: 10.34067/KID.0005182021. eCollection 2021 Dec 30.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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15-009053
Identifier Type: -
Identifier Source: org_study_id
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