Actively Recruiting

Phase 1
Age: 18Years - 85Years
All Genders
NCT04392206

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Led by Houssam Farres, M.D. · Updated on 2025-08-12

15

Participants Needed

1

Research Sites

367 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 with documentation or pregnancy testing
Not Eligible

You will not qualify if you...

  • 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 deep vein thromboses or other spontaneous intravascular thrombotic events
  • Treatment with any investigational drug or device within 60 days prior to study entry
  • Any condition that would prevent adequate evaluation of AMSCs and AVF safety and efficacy
  • History of failed organ transplant on immunosuppression
  • Known active infection being treated

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

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Research Team

R

Reagan Dukes

CONTACT

M

Mauricia Buchanan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses | DecenTrialz