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ACTIVE NOT RECRUITING
NCT02808208
PHASE1

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2017-06-07

Completion Date

2026-12

Last Updated

2026-01-07

Healthy Volunteers

No

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States