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Stem Cell Therapy

AMSC for Kidney Failure

Phase 1
Recruiting
Led By Albert Hakaim, MD
Research Sponsored by Albert Hakaim
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events

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.

Find a Location

Who is running the clinical trial?

Albert HakaimLead Sponsor
Albert Hakaim, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital Jacksonville
Ohio State University College Of Medicine (Medical School)
Cleveland Clinic Fndn (Residency)
1 Previous Clinical Trials
2,700 Total Patients Enrolled

Media Library

Adipose Derived Mesenchymal Stem Cells (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04392206 — Phase 1
Kidney Failure Research Study Groups: Adipose Derived Mesenchymal Stem Cells
Kidney Failure Clinical Trial 2023: Adipose Derived Mesenchymal Stem Cells Highlights & Side Effects. Trial Name: NCT04392206 — Phase 1
Adipose Derived Mesenchymal Stem Cells (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04392206 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to be a participant in this research endeavor?

"This clinical trial calls for 15 renal failure patients aged 18-85 to meet the following criteria: adequate lifespans of at least 24 months, a preplanned upper extremity arteriovenous fistula, and postmenopausal/nonreproductive capability that is either reflected in medical records or verified with an official pregnancy test."

Answered by AI

Does this medical experiment include younger participants under the age of eighteen?

"The enrollment guidelines for this clinical study stipulate that the youngest participants must be at least 18 years of age, with a maximum age limit of 85."

Answered by AI

What risks, if any, are associated with using Adipose Derived Mesenchymal Stem Cells in patients?

"Limited data regarding the safety and efficacy of Adipose Derived Mesenchymal Stem Cells resulted in a score of 1."

Answered by AI

Is there still availability for potential participants in this trial?

"Affirmative. Per the information available on clinicaltrials.gov, this health experiment is currently recruiting sufferers for participation; it was initially advertised on May 15th 2020 and last amended July 27th 2022. The trial seeks to enroll a total of fifteen participants across one medical centre."

Answered by AI

What is the maximum capacity of participants for this research study?

"Affirmative. The clinicaltrials.gov site confirms that this trial, first uploaded on May 15th 2020, is currently searching for participants. Specifically, they hope to enlist 15 individuals from one medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Albert Hakaim 2020. "AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04392206.
~3 spots leftby Jun 2025
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