AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Description

Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.

Conditions

End Stage Renal Disease

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Study Overview

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Study Details

Study overview

Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.

A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Condition
End Stage Renal Disease
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient between 18 and 85 years old
  • * Patient currently planned for 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
  • * If female, must be post-menopausal or not able to have children. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed.
  • * 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
  • * 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
  • * History of failed organ transplant on immunosuppression.
  • * Subjects with known active infection (infection which is being treated)

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Houssam Farres, M.D.,

Houssam Farres, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-06