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

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02808208
Collaborator
(none)
74
Enrollment
1
Location
5
Arms
65.8
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
  • Drug: Placebo
  • Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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 :
Jun 7, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Biological: 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 Intervention: No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula

Patients receive standard of care.
Experimental: 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

Biological: 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.
Experimental: 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

Biological: 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 Comparator: Placebo treatment in brachiobasilic arteriovenous fistula

Subjects will receive placebo at first and second stage of BBF

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Hemodialysis outflow vein diameter [Baseline to 12 months after AVF creation]

    Diameter of outflow vein by ultrasound

Secondary Outcome Measures

  1. Hemodialysis AVF Blood flow [Baseline to 12 months after AVF creation]

    blood flow by ultrasound or dialysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Sanjay Misra, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sanjay Misra, M.D., M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02808208
Other Study ID Numbers:
  • 15-009053
First Posted:
Jun 21, 2016
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Failure, Chronic
Arteriovenous Fistula
Fistula

Study Results

No Results Posted as of Jan 20, 2022