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

Phase 1

Active, not recruiting

• Conditions: End Stage Renal Disease (ESRD); Vascular Access Complication
• Interventions: Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC); Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC); Drug: Placebo

• Registration Number: NCT02808208
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Study Start: 2017-06-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula	Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)	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
Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula	Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)	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)
AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula	Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)	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
Placebo treatment in brachiobasilic arteriovenous fistula	Placebo	Subjects will receive placebo at first and second stage of BBF

Primary Outcome Measures

Name	Time	Method
Hemodialysis outflow vein diameter	Baseline to 12 months after AVF creation	Diameter of outflow vein by ultrasound

Secondary Outcome Measures

Name	Time	Method
Hemodialysis AVF Blood flow	Baseline to 12 months after AVF creation	blood flow by ultrasound or dialysis

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States