AMSC for Fistula in Hemodialysis Patients

Phase 1 & 2

Waitlist Available

Led By Sanjay Misra, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months after avf creation

Summary

This trial is testing whether using a patient's own stem cells can reduce the failure rate of a common surgery for people with kidney failure.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

As this is a phase 1 trial primarily assessing safety, specific side effects are being determined; however, potential risks may include infection at the injection site, allergic reactions to components of the preparation process, and unforeseen complications related to stem cell therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months after avf creation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months after avf creation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months after avf creation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hemodialysis outflow vein diameter

Secondary study objectives

Hemodialysis AVF Blood flow

Trial Design

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

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