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AMSC for Reducing Anastomotic Stenosis in Dialysis Access

This study is looking at whether Adipose Derived Mesenchymal Stem Cells (AMSC) can help reduce problems with dialysis access (arteriovenous fistula) in people with End Stage Renal Disease. Researchers want to see if AMSC, given during the creation of the access, can make it work better and last longer. The main goal is to check for any treatment-related side effects over 12 months. You might be able to join if you are between 18 and 85 years old, are planning to have an upper arm AV fistula created, and are expected to live at least 24 months. The study is currently unclear on its recruitment status and plans to enroll 15 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 15 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-related adverse events for 12 months.

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NCT04392206

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Recruiting
PHASE1Ages 18–85InterventionalTreatment
Houssam Farres, M.D.
~15 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Adipose Derived Mesenchymal Stem Cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events
Measured over 12 months

Conditions

End Stage Renal Disease

Explore related trials

Chronic Kidney Disease, Stage 5

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Houssam Farres, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Reagan Dukes
[email protected]
(904) 953-2077
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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)

What this trial measures

  • Number of participants with treatment-related adverse events12 months

    Evaluate the safety of AMSC administration by assessing the number of participants to experience an adverse event as defined by inflammation, infection (local or systemic), aneurysm formation, clinically significant increase or decrease in blood flow or thrombosis formation as evaluated through physical exam and ultrasound.