NCT06509828

Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection

Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection (EAP-STOMP2)

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Avobis Bio, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial (STOMP-II), but who were subsequently not treated with AVB-114 because they did not meet all eligibility criteria or the investigational product was not successfully manufactured.

Detailed description

AVB-114 is an autologous investigational product under evaluation in Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II; a prospective, multicenter, randomized, blinded outcome assessment, controlled, add-on therapy phase II study) for the treatment of complex perianal fistulas in subjects with Crohn's disease. EAP-STOMP2 is an expanded access protocol for patients who had adipose tissue collected per the STOMP-II protocol, but who were subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew from the study. Patients will receive AVB-114 as deemed appropriate by investigator and Avobis Bio.

Conditions

• Perianal Fistula Due to Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	AVB-114	AVB-114 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.

Timeline

• First posted: 2024-07-19
• Last updated: 2024-07-19