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Stem Cell Therapy

AMSC for Kidney Failure

Phase 1

Recruiting

Led By Houssam Farres, MD

Research Sponsored by Houssam Farres, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures

Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy

Must not have

Immunodeficiency including AIDS / HIV or Active autoimmune disease

History of failed organ transplant on immunosuppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe to use a person's own stem cells to improve access for hemodialysis and whether it is effective.

Who is the study for?

This trial is for adults aged 18-85 with chronic kidney failure who need a new hemodialysis access point and have a life expectancy of over 2 years. Participants must be able to follow the study plan, give informed consent, and women must be unable to bear children or post-menopausal. People can't join if they've been in another drug/device study recently, have active infections, cancer treatments within 6 months, immune system problems like HIV/AIDS or autoimmune diseases, or a history of blood clotting issues.

What is being tested?

The trial is testing the safety and effectiveness of injecting Adipose Derived Mesenchymal Stem Cells (AMSC) during surgery to create an arteriovenous fistula for dialysis. The goal is to see if AMSCs help the new connection mature better and stay open without blockages.

What are the potential side effects?

Potential side effects may include reactions at the injection site, risk of infection due to stem cell use from another person (allogeneic), immune system responses against these cells leading possibly to autoimmune-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can communicate clearly, understand the study, and follow all procedures.

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I am scheduled for a procedure to create a vein-artery connection in my arm.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have HIV/AIDS or an active autoimmune disease.

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I have had an organ transplant that failed while on immunosuppression.

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I have a condition that causes my blood to clot easily or I've had 2 or more deep vein thromboses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with treatment-related adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adipose Derived Mesenchymal Stem CellsExperimental Treatment1 Intervention

Subjects diagnosed with End Stage Renal Disease (ESRD) and are currently on hemodialysis therapy with planned creation of a new upper extremity arteriovenous fistula will receive Adipose Derived Mesenchymal Stem Cells treatment.

0 / 6Eligibility criteria met