NCT02808208

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-06-07
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2016-06-21
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study