Perianal FistulaPhase 2NCT04847739

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

A Phase 2 study testing Seton Placement and AVB-114 in people with Perianal Fistula and Crohn's Disease, run by Avobis Bio, LLC at 15 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Perianal Fistula, Crohn's Disease
What is being tested?: Seton Placement and AVB-114
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 15 sitesUnited States
Study dates: 13 Sep 2021to Aug 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 33Show fewer

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.
Any major surgery of the gastrointestinal tract (including one or more segments of the colon or terminal ileum) within 3 months prior to screening visit. Presence of stoma is not exclusionary.
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:
Horseshoe fistulas
Fistulas that do not have an opening inside the anal canal or low rectum
Blind ending sinus tracts (no external opening)
Branching fistulas. A previously performed conversion of a branching fistula tract to a single tract is not exclusionary
>1 internal opening
Moderate or severe proctitis
Severe rectal mucosal fibrosis surrounding the internal opening preventing the securing of the fistula plug cap.
Any anatomical limitation to successfully securing the fistula plug cap
Evidence by colonoscopy of moderately or greater active luminal CD.
Subject with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to screening and baseline study visits.
History of, or concurrent high-grade dysplasia, adenocarcinoma, and carcinoma in situ on colonoscopy within 5 years of screening visit.
Subjects with renal insufficiency (creatinine value > 1.8 mg/dL, eGFR < 44, or patient undergoing dialysis).
Subjects with a hemoglobin less than 8 gm/dL.
Subjects with serum aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the upper limit of normal (ULN).
Subjects with an abscess within the fistula tract that cannot be resolved prior to treatment.
Subjects with known coagulopathy (abnormal INR) or thrombocytopenia as indicated by a platelet count < 75,000.
Subjects with history of substance abuse (drug or alcohol) that would interfere with the ability to comply with the study protocol and study requirements.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

University of Colorado School of Medicine
Aurora, Colorado, 80045
Mass Gen Hospital
Boston, Massachusetts, 02114
UChicago Medicine and Biological Sciences
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Office of Phillip Fleshner, MD
Los Angeles, California, 90048
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone Health
New York, New York, 10016
Weill Cornell Medical College - NY Presbyterian Hospital
New York, New York, 10021
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Stanford University
Redwood City, California, 94063
Mayo Clinic
Rochester, Minnesota, 55905
UC Davis
Sacramento, California, 95817

Other trials in United States

About this study

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.

Read the detailed 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.

Conditions: Perianal Fistula, Crohn's Disease
Being tested: Seton Placement, AVB-114
Keywords: Matrix plug, Mesenchymal stem cells, Fistula plug, Refractory, Recurrent, STOMP, Autologous
Medical subject headings: Crohn Disease, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Seton PlacementProcedure or surgery
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.
AVB-114Drug
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.

Study groups in NCT04847739
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Seton Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in proportions of subjects with combined remission of treated perianal fistula between the AVB-114 and standard of care groups.
Measured: 36 weeks

Secondary outcomes (14)

Change in proportions of subjects with fistula clinical remission between the AVB-114 and standard of care groups.
Measured: Week 12 to Week 104
Change in the means of durability of clinical remission between the AVB-114 and standard of care groups.
Length of time fistula meets clinical remission definition.
Measured: Week 12 to Week 104
Change in means of time to clinical remission between the AVB-114 and standard of care groups.
Measured: Week 12 to Week 104
Change in proportions of subjects with fistula relapse between the AVB-114 and standard of care groups.
Measured: Week 12 to Week 104
Change in means of time to fistula relapse between the AVB-114 and standard of care groups.
Measured: Week 12 to Week 104
Change in proportions of radiologic response of treated fistula between the AVB-114 and standard of care groups.
Measured: Baseline, Week 12 to Week 52
Change in means of disease activity index scores using the Perianal Disease Activity Index (PDAI) between the AVB-114 and standard of care groups.
Perianal Disease Activity Index (PDAI). Possible scores range from 0-20, with a higher score indicating more severe perianal disease activity
Measured: Baseline, Week 36
Change in means of disease activity index scores using the short Crohn's Disease Activity Index (sCDAI) between the AVB-114 and standard of care groups.
Short Crohn's Disease Activity Index (sCDAI). Possible scores range from 44 to >450, with a higher score representing more severe disease activity
Measured: Baseline, Week 36
Change in means of patient quality of life assessment scores using the Euroqol 5 Diumention 5, level measure of health status (Eq-5Q-5L) between the AVB-114 and standard of care groups.
Euroqol 5 Dimension 5, level measure of health status (EQ-5D-5L). The scale ranges in scores from 0 to 100, with a higher score indicating a more severe health status.
Measured: Baseline, Week 36
Change in means of patient quality of life assessment scores using the Inflammatory Bowel Disease Questionnaire (IBDQ) between the AVB-114 and standard of care groups.
Inflammatory Bowel Disease Questionnaire (IBDQ). Possible scores range from 32-224, with a higher score indicating a better health-related quality of life.
Measured: Baseline, Week 36
Change in patient assessment of impact to daily functionality related to treated fistula between the AVB-114 and standard of care groups.
Days of missed work or activity and reason why will be captured.
Measured: Baseline, Week 12 to Week 36
Change in the evaluations of patient care trajectory related to treated fistula between the AVB-114 and standard of care groups.
Number and type of healthcare resources utilized will be captured.
Measured: Week 12 to Week 36
Change in number of adverse events between the AVB-114 and standard of care groups.
Measured: Day 1 to Week 104
Change in number of serious adverse events between the AVB-114 and standard of care groups.
Measured: Day 1 to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 2021Aug 2026

First posted19 Apr 2021
Study start13 Sep 2021
Primary completionMay 2025 (estimated)
Study completionAug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Perianal FistulaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04847739
Sponsor's protocol ID: STOMP-II
Status last verified: Jul 2024
First submitted: 1 Apr 2021
Last updated: 1 Aug 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Schwartz DA, Dozois E, Ehman E, Faubion W Jr, Hudesman D, Johnson T, Pabla B, Papadakis K, Fleshner P. AVB-114 Demonstrates Clinical Benefit in Persistent Crohn's Perianal Fistulas: Randomized Cohort Results From the Multicenter STOMP2 Trial. Am J Gastroenterol. 2026 Mar 25. doi: 10.14309/ajg.0000000000004005. Online ahead of print.
PubMed 41879234

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
ClinicalTrials.gov ID: NCT04847739
Acronym / sponsor ID: STOMP-II
Conditions: Perianal Fistula, Crohn's Disease
Keywords: Matrix plug, Mesenchymal stem cells, Fistula plug, Refractory, Recurrent, STOMP, Autologous
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Avobis Bio, LLCIndustry (pharma, biotech, devices)
Collaborators: Alimentiv Inc.
Study start: 13 Sep 2021 (actual)
Primary completion: May 2025 (estimated)
Study completion: Aug 2026 (estimated)
First posted: 19 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard of Care Treatment + AVB-114	Experimental	Procedure: Seton Placement, Drug: AVB-114Subjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and the AVB-114 study treatment is inserted.
Standard of Care Treatment	Active comparator	Procedure: Seton PlacementSubjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and then replaced.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (33 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Seton PlacementThis 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.	Procedure or surgery	Standard of Care Treatment, Standard of Care Treatment + AVB-114
AVB-114AVB-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.	Drug	Standard of Care Treatment + AVB-114

Primary outcome

Change in proportions of subjects with combined remission of treated perianal fistula between the AVB-114 and standard of care groups.
Time frame: 36 weeks

14 secondary outcomes

Change in proportions of subjects with fistula clinical remission between the AVB-114 and standard of care groups.
Time frame: Week 12 to Week 104
Change in the means of durability of clinical remission between the AVB-114 and standard of care groups.
Time frame: Week 12 to Week 104
Change in means of time to clinical remission between the AVB-114 and standard of care groups.
Time frame: Week 12 to Week 104
Change in proportions of subjects with fistula relapse between the AVB-114 and standard of care groups.
Time frame: Week 12 to Week 104
Change in means of time to fistula relapse between the AVB-114 and standard of care groups.
Time frame: Week 12 to Week 104
Change in proportions of radiologic response of treated fistula between the AVB-114 and standard of care groups.
Time frame: Baseline, Week 12 to Week 52
Change in means of disease activity index scores using the Perianal Disease Activity Index (PDAI) between the AVB-114 and standard of care groups.
Time frame: Baseline, Week 36
Change in means of disease activity index scores using the short Crohn's Disease Activity Index (sCDAI) between the AVB-114 and standard of care groups.
Time frame: Baseline, Week 36
Change in means of patient quality of life assessment scores using the Euroqol 5 Diumention 5, level measure of health status (Eq-5Q-5L) between the AVB-114 and standard of care groups.
Time frame: Baseline, Week 36
Change in means of patient quality of life assessment scores using the Inflammatory Bowel Disease Questionnaire (IBDQ) between the AVB-114 and standard of care groups.
Time frame: Baseline, Week 36
Change in patient assessment of impact to daily functionality related to treated fistula between the AVB-114 and standard of care groups.
Time frame: Baseline, Week 12 to Week 36
Change in the evaluations of patient care trajectory related to treated fistula between the AVB-114 and standard of care groups.
Time frame: Week 12 to Week 36
Change in number of adverse events between the AVB-114 and standard of care groups.
Time frame: Day 1 to Week 104
Change in number of serious adverse events between the AVB-114 and standard of care groups.
Time frame: Day 1 to Week 104

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
Derived from this study: PubMed 41879234Schwartz DA, Dozois E, Ehman E, Faubion W Jr, Hudesman D, Johnson T, Pabla B, Papadakis K, Fleshner P. AVB-114 Demonstrates Clinical Benefit in Persistent Crohn's Perianal Fistulas: Randomized Cohort Results From the Multicenter STOMP2 Trial. Am J Gastroenterol. 2026 Mar 25. doi: 10.14309/ajg.0000000000004005. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joan Morris study director

Alimentiv Inc.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Seton Placement and AVB-114 in people with Perianal Fistula and Crohn's Disease, run by Avobis Bio, LLC at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in proportions of subjects with combined remission of treated perianal fistula between the AVB-114 and standard of care groups. (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04847739, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.