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

NCT04847739 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STOMP-II
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Perianal Fistula; Crohn's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in proportions of subjects with combined remission of treated perianal fistula between the AVB-114 and standard of care groups.

  36 weeks

Secondary Outcomes (14)

• Change in proportions of subjects with fistula clinical remission between the AVB-114 and standard of care groups.

  Week 12 to Week 104

• Change in the means of durability of clinical remission between the AVB-114 and standard of care groups.

  Week 12 to Week 104

• Change in means of time to clinical remission between the AVB-114 and standard of care groups.

  Week 12 to Week 104

• Change in proportions of subjects with fistula relapse between the AVB-114 and standard of care groups.

  Week 12 to Week 104

• Change in means of time to fistula relapse between the AVB-114 and standard of care groups.

  Week 12 to Week 104

Study Arms (2)

Standard of Care Treatment + AVB-114

EXPERIMENTAL

Subjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and the AVB-114 study treatment is inserted.

Procedure: Seton Placement; Drug: AVB-114

Standard of Care Treatment

ACTIVE COMPARATOR

Subjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and then replaced.

Procedure: Seton Placement

Interventions

Seton Placement PROCEDURE

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.

Standard of Care Treatment; Standard of Care Treatment + AVB-114

AVB-114 DRUG

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.

Standard of Care Treatment + AVB-114

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated ICF.
• Ability and willingness to comply with study protocol and study requirements for the duration of the study.
• Male or female, 18-70 years of age
• Subjects with CD diagnosed at least 6 months prior to screening visit.
• Subjects with a single fistula tract with one internal opening and one external opening.
• Subjects whose perianal fistula(s) were previously treated with either biologic or conventional therapy whose fistula has demonstrated a failed response or who have documented medication intolerance.
• Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 IU human chorionic gonadotropin). WCBP participating in this study must agree to use an adequate method of contraception during the entire duration of the study. Males who have sexual partners that are women of childbearing potential must be willing to use a barrier method for contraception for the duration of study.

You may not qualify if:

• Clinically significant medical conditions within the six months before screening that would, in the opinion of the investigator, compromise the safety of the subject with study participation and/or the ability of the subject to follow study protocol.
• Evidence of hepatitis B, C, or HIV or subjects with congenital or acquired immunodeficiencies.
• Participation in an investigational drug study (within 30 days of last administration from screening visit) or investigational medical device study (within 1 year of implant from screening visit) where investigational treatment (drug or device) is placed in rectum, vagina, or near fistula location, or that may potentially interact with study treatment.
• History (within previous 5 years of screening visit) of invasive cancer including melanoma (with the exception of localized skin cancers).
• Subjects pregnant, trying to become pregnant, or are breast feeding.
• Subjects with known allergies or hypersensitivity to aminoglycosides and contraindications to Magnetic Resonance (MR) evaluations and/or to MR contrast.
• History of clinically significant fat-directed autoimmunity.
• Genito-urinary fistulization, including rectovaginal (i.e., fistulae that transverse the vaginal canal).
• Presence of an ileal anal pouch.
• Active, unresolved infection requiring parenteral antibiotics.
• Subjects who had a definitive surgical procedure for the target fistula or a perianal procedure that resulted in a large soft tissue defect within 6 months prior to screening visit.
• Subjects where the target adipose collection harvest site is compromised due to a previous cool sculpting procedure, local radiation, chemotherapy, recent tattoos, local infection, or other reasons that may compromise the adipose tissue for study use.
• Subjects previously treated with Cx601/Alofisel or other allogeneic or autologous stem-cell therapy within the past 6 months.
• Contraindications to the anesthetic procedure (local and general) or to the adipose tissue collection procedure.
• Subjects with one or more of the following fistula types or anatomic presentations:

Sponsors & Collaborators

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

Study Sites (15)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Office of Phillip Fleshner, MD

Los Angeles, California, 90048, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

UChicago Medicine and Biological Sciences

Chicago, Illinois, 60637, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Mass Gen Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Weill Cornell Medical College - NY Presbyterian Hospital

New York, New York, 10021, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Crohn Disease; Recurrence

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Morris

  Alimentiv Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 19, 2021
• Study Start: September 13, 2021
• Primary Completion: May 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)