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Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

NCT02808208 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-01-07

No results posted yet for this study

Summary

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.

Conditions

  • End Stage Renal Disease (ESRD)
  • Vascular Access Complication

Interventions

BIOLOGICAL

Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)

A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.

DRUG

Placebo

5-mL of Lactated Ringers solution topical application to the surface of the outflow vein (right next to the fistula) over a five-minute period.

BIOLOGICAL

Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)

Two topical applications of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period at stage one and two of fistula surgery

Sponsors & Collaborators

Principal Investigators

  • Sanjay Misra, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-07
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808208 on ClinicalTrials.gov