Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 13, 2021

Primary Completion Date

May 31, 2025

Study Completion Date

August 31, 2026

Conditions
Perianal FistulaCrohn's Disease
Interventions
PROCEDURE

Seton Placement

This treatment consists of inserting a seton (a soft flexible tube or nonabsorbable string) into the subject's perianal fistula. The seton will be removed by a study doctor at study visits as applicable.

DRUG

AVB-114

AVB-114 consists of stem cells taken from a subject's fat tissue seeded into a bioabsorbable plug. AVB-114 will be inserted into the subject's fistula by a study doctor on Day 0.

Trial Locations (15)

10016

NYU Langone Health, New York

10021

Weill Cornell Medical College - NY Presbyterian Hospital, New York

32224

Mayo Clinic Jacksonville, Jacksonville

33136

University of Miami, Miami

37232

Vanderbilt University Medical Center, Nashville

45267

University of Cincinnati, Cincinnati

46202

Indiana University Health University Hospital, Indianapolis

55905

Mayo Clinic, Rochester

60637

UChicago Medicine and Biological Sciences, Chicago

80045

University of Colorado School of Medicine, Aurora

85054

Mayo Clinic Arizona, Phoenix

90048

Office of Phillip Fleshner, MD, Los Angeles

94063

Stanford University, Redwood City

95817

UC Davis, Sacramento

02114

Mass Gen Hospital, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Alimentiv Inc.

OTHER

lead

Avobis Bio, LLC

INDUSTRY

NCT04847739 - Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II) | Biotech Hunter | Biotech Hunter