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

NCT02808208 Phase 1 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Mayo Clinic
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	74
Start date	2017-06-07
Completion	2026-12

Conditions

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

Interventions

• Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
• Placebo
• Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)

Primary outcomes

• Hemodialysis outflow vein diameter — Baseline to 12 months after AVF creation
  Diameter of outflow vein by ultrasound

Countries

United States