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

NCT06509828 | Unknown

• 1 other identifier: EAP-STOMP2
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perianal Fistula Due to Crohn's Disease

Keywords

Matrix plug; Mesenchymal stem cells; Fistula plug; Refractory; Recurrent; STOMP; Autologous

Interventions

AVB-114 BIOLOGICAL

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated ICF.
• Adipose tissue previously collected per the STOMP-II protocol, but were subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew.
• Diagnosed with Crohn's disease and a target perianal fistula with one internal opening and at least one external opening.

You may not qualify if:

• Suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety.
• Pregnant, trying to become pregnant, or are breast feeding. Women of childbearing potential (WCBP) and males who have sexual partners that are WCBP must agree to use an adequate method of contraception while participating in this EAP.
• Known allergies or hypersensitivity to aminoglycosides.
• History of clinically significant fat-directed autoimmunity.
• Active, unresolved infection requiring parenteral antibiotics.
• Unresolved abscess at time of treatment (if screening Pelvic MRI identifies an abscess, it must be resolved before treatment).
• Target fistula has a branching blind ending sinus tract (no external opening) that investigator assesses to be at elevated risk of abscess formation if treated with AVB-114.
• Target fistula is a genito-urinary fistula, including rectovaginal (i.e., fistulae that transverse the vaginal canal).
• Any anatomical limitation to successfully securing the fistula plug disk.

Sponsors & Collaborators

• Avobis Bio, LLC: lead
• Alimentiv Inc.: collaborator

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Todd Johnson

CONTACT

928-864-2419; expandedaccess@avobisbio.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 19, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07