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

Primary Purpose

End Stage Renal Disease (ESRD), Vascular Access Complication

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
Placebo
Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease (ESRD)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Experimental

Experimental

Placebo Comparator

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Hemodialysis outflow vein diameter
Diameter of outflow vein by ultrasound

Secondary Outcome Measures

Hemodialysis AVF Blood flow
blood flow by ultrasound or dialysis

Full Information

First Posted
June 2, 2016
Last Updated
January 9, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02808208
Brief Title
Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
Official Title
A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD), Vascular Access Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Arm Type
Experimental
Arm Description
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)
Arm Title
No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Arm Type
No Intervention
Arm Description
Patients receive standard of care.
Arm Title
Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula
Arm Type
Experimental
Arm Description
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
Arm Title
AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo treatment in brachiobasilic arteriovenous fistula
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo at first and second stage of BBF
Intervention Type
Biological
Intervention Name(s)
Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
Intervention Description
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
Primary Outcome Measure Information:
Title
Hemodialysis outflow vein diameter
Description
Diameter of outflow vein by ultrasound
Time Frame
Baseline to 12 months after AVF creation
Secondary Outcome Measure Information:
Title
Hemodialysis AVF Blood flow
Description
blood flow by ultrasound or dialysis
Time Frame
Baseline to 12 months after AVF creation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Misra, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35419530
Citation
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.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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