AMSC for Fistula in Hemodialysis Patients

Recruiting in Palo Alto (17 mi)

Overseen bySanjay Misra, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Mayo Clinic

Trial Summary

What is the purpose of this trial?

The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.

Research Team

Sanjay Misra, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 18-85 on hemodialysis or pre-dialysis needing an upper extremity AV fistula, who can consent and follow the study plan. They should expect to live at least two more years. It's not for sponsor employees, pregnant/breastfeeding individuals, recent investigational drug/device users, cancer patients within six months, those with immune/autoimmune diseases or a history of clotting issues.

Inclusion Criteria

You are between 18 and 85 years old.

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

You are currently receiving hemodialysis or are planning to receive hemodialysis with a specific type of access in your arm.

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Exclusion Criteria

Employees of the sponsor or patients who are employees or relatives of the investigator

Pregnancy or breast feeding

Treatment with any investigational drug/ device within 60 days prior to study entry

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Treatment Details

Interventions

Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) (Mesenchymal Stem Cells)

Trial OverviewThe study tests if one or two applications of patient's own fat-derived stem cells (AMSC) can reduce failure rates in newly created arteriovenous fistulas used for hemodialysis compared to a placebo. This phase 1 trial aims to improve vascular access longevity.

Participant Groups

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistulaExperimental Treatment1 Intervention

Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)

Group II: Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistulaExperimental Treatment1 Intervention

Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF

Group III: AMSC treatment at first and second stage of brachiobasilic arteriovenous fistulaExperimental Treatment1 Intervention

Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF

Group IV: No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistulaActive Control1 Intervention

Patients receive standard of care.

Group V: Placebo treatment in brachiobasilic arteriovenous fistulaPlacebo Group1 Intervention

Subjects will receive placebo at first and second stage of BBF