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
1 other identifier
interventional
74
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedStudy Start
First participant enrolled
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 7, 2026
January 1, 2026
9.5 years
June 2, 2016
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Hemodialysis outflow vein diameter
Diameter of outflow vein by ultrasound
Baseline to 12 months after AVF creation
Secondary Outcomes (1)
Hemodialysis AVF Blood flow
Baseline to 12 months after AVF creation
Study Arms (5)
Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
EXPERIMENTALSubjects 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)
No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
NO INTERVENTIONPatients receive standard of care.
Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula
EXPERIMENTALSubjects 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
AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula
EXPERIMENTALSubjects 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
Placebo treatment in brachiobasilic arteriovenous fistula
PLACEBO COMPARATORSubjects will receive placebo at first and second stage of BBF
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
PMID: 35419530DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay Misra, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 21, 2016
Study Start
June 7, 2017
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share