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

Status Recruiting

Clinical Trial Summary

A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm. The study has 2 parts: Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm). Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.

Clinical Trial Description

AVB-114 is an investigational therapy which offers a new therapeutic approach to treating this unmet medical need. The drug product is a mesenchymal cell substrate system comprised of autologous mesenchymal cells incubated with a 3-dimensional bioabsorbable substrate. The drug substance is expanded, pure mesenchymal stem cells (MSC) which are known to modulate local inflammation and orchestrate tissue healing. By incubating cells with a 3-dimensional bioabsorbable substrate designed for anal fistula geometry, cells are locally delivered into the fistula tract to promote healing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04847739
Study type	Interventional
Source	Avobis Bio, LLC
Contact	Alimentiv Inc
Phone	416-898-5326
Email	STOMP2PM@alimentiv.com
Status	Recruiting
Phase	Phase 2
Start date	September 13, 2021
Completion date	May 2026

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