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

July 12, 2024 updated by: Avobis Bio, LLC

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

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. Provision of signed and dated ICF.
  2. 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.
  3. Diagnosed with Crohn's disease and a target perianal fistula with one internal opening and at least one external opening.

Exclusion Criteria:

  1. Suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety.
  2. 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.
  3. Known allergies or hypersensitivity to aminoglycosides.
  4. History of clinically significant fat-directed autoimmunity.
  5. Active, unresolved infection requiring parenteral antibiotics.
  6. Unresolved abscess at time of treatment (if screening Pelvic MRI identifies an abscess, it must be resolved before treatment).

  7. Target fistula with any of the following characteristics (note that presence of a second fistula tract that is distinctly separate from the target fistula, or a target fistula with a single internal opening and multiple external openings is not exclusionary):

    1. 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.
    2. Target fistula is a genito-urinary fistula, including rectovaginal (i.e., fistulae that transverse the vaginal canal).
    3. Any anatomical limitation to successfully securing the fistula plug disk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avobis Bio, LLC

Collaborators

Alimentiv Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAP-STOMP2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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