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

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ClinicalTrials.gov Identifier: NCT02808208
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2016
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Sanjay Misra, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 2, 2016
First Posted Date  ICMJE June 21, 2016
Last Update Posted Date July 26, 2021
Actual Study Start Date  ICMJE June 7, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
Hemodialysis outflow vein diameter [ Time Frame: Baseline to 12 months after AVF creation ]
Diameter of outflow vein by ultrasound
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
Hemodialysis AVF Blood flow [ Time Frame: Baseline to 12 months after AVF creation ]
blood flow by ultrasound or dialysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
Official Title  ICMJE A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • End Stage Renal Disease (ESRD)
  • Vascular Access Complication
Intervention  ICMJE
  • 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.
  • 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.
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
  • 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
    Intervention: Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
  • 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
    Intervention: Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
  • Placebo Comparator: Placebo treatment in brachiobasilic arteriovenous fistula
    Subjects will receive placebo at first and second stage of BBF
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 19, 2021)
74
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2016)
44
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02808208
Other Study ID Numbers  ICMJE 15-009053
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanjay Misra, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjay Misra, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP