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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

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
End Stage Renal Disease (ESRD) Vascular Access Complication 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 7, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

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.




Primary Outcome Measures :
  1. Hemodialysis outflow vein diameter [ Time Frame: Baseline to 12 months after AVF creation ]
    Diameter of outflow vein by ultrasound


Secondary Outcome Measures :
  1. Hemodialysis AVF Blood flow [ Time Frame: Baseline to 12 months after AVF creation ]
    blood flow by ultrasound or dialysis



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808208


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Sanjay Misra, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Sanjay Misra, M.D., M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02808208    
Other Study ID Numbers: 15-009053
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Arteriovenous Fistula
Fistula
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic
Renal Insufficiency
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities