A Study of Using Mesenchymal Stem Cells Developed from the Patients Own Fat Tissue for Reducing Hemodialysis Arteriovenous Fistula Failure

Overview

About this study

The purpose of this study is to determine the success of mesenchymal stem cells, developed from the patient's own fat tissue, for reducing hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • 18 to 85 years old.
  • Has planned the creation of an upper extremity AV fistula with suitable anatomy.
  • Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able 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.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sanjay Misra, M.D.

Open for enrollment

Contact information:

Ann Nielsen R.N.

(507)293-0947

Nielsen.Ann@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20266930

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