RecruitingPhase 1NCT04392206

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

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


Sponsor

Houssam Farres, M.D.

Enrollment

15 participants

Start Date

May 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether injecting special cells called adipose-derived mesenchymal stem cells (AMSCs) — taken from fat tissue — around a newly created arteriovenous (AV) fistula can reduce the chance of the fistula narrowing or becoming blocked. AV fistulas are surgically created connections between an artery and vein used for dialysis access in people with kidney failure. **You may be eligible if...** - You are between 18 and 85 years old - You are scheduled to have an AV fistula created in your arm for dialysis - Your vein and artery anatomy is suitable for the procedure - You are able to communicate with study staff and give written consent - Your life expectancy is at least 24 months - If female, you are post-menopausal or unable to have children **You may NOT be eligible if...** - You have had cancer or been treated for cancer in the past 6 months - You have HIV, AIDS, or an active autoimmune disease - You have a known clotting disorder or a history of multiple blood clots - You have a known active infection - You have had a failed organ transplant and are on immunosuppression - You are on an experimental drug or device within the past 60 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdipose Derived Mesenchymal Stem Cells

The dose will be specifically tailored to each subject's vascular anatomy determined by the surgeon through ultrasound measurements. Approximately 3-5 million cells in 5ml Ringer Lactate (RL) Solution


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT04392206


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