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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 : Recruiting
First Posted : June 21, 2016
Last Update Posted : February 6, 2019
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: Adipose Derived Mesenchymal Stem Cells (AMSC) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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 : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arm Intervention/treatment
Experimental: Group 1 AMSC Treatment
Patients have tissue biopsy and Adipose Derived Mesenchymal Stem Cells (AMSC) treatment.
Biological: Adipose Derived Mesenchymal Stem Cells (AMSC)
This group will receive Autologous stem cells derived from own fat biopsy.

No Intervention: Group 2 No Treatment
Patients receive standard of care.



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



Information from the National Library of Medicine

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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


Contacts
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Contact: Lori Johnson 507-266-0899 Johnson.Lori@mayo.edu
Contact: Matthew Hoplin 507-293-0947 Hoplin.Matthew@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Sanjay Misra, M.D. Mayo Clinic

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Responsible Party: Sanjay Misra, M.D., M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02808208     History of Changes
Other Study ID Numbers: 15-009053
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
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
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Arteriovenous Fistula
Fistula
Urologic Diseases
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities