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Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas

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ClinicalTrials.gov Identifier: NCT04847739
Recruitment Status : Not yet recruiting
First Posted : April 19, 2021
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
Alimentiv Inc.
Information provided by (Responsible Party):
Avobis Bio, LLC

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.


Condition or disease Intervention/treatment Phase
Perianal Fistula Crohn's Disease Procedure: Seton Placement Drug: AVB-114 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Standard of Care Treatment + AVB-114
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
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.

Drug: AVB-114
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.

Active Comparator: Standard of Care Treatment
Subjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and then replaced.
Procedure: Seton Placement
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
    Length of time fistula meets clinical remission definition.

  3. Change in means of time to clinical remission between the AVB-114 and standard of care groups. [ Time Frame: Week 12 to Week 104 ]
  4. Change in proportions of subjects with fistula relapse between the AVB-114 and standard of care groups. [ Time Frame: Week 12 to Week 104 ]
  5. Change in means of time to fistula relapse between the AVB-114 and standard of care groups. [ Time Frame: Week 12 to Week 104 ]
  6. 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 ]
  7. 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 ]
    Perianal Disease Activity Index (PDAI). Possible scores range from 0-20, with a higher score indicating more severe perianal disease activity

  8. 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 ]
    Short Crohn's Disease Activity Index (sCDAI). Possible scores range from 44 to >450, with a higher score representing more severe disease activity

  9. 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 ]
    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.

  10. 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 ]
    Inflammatory Bowel Disease Questionnaire (IBDQ). Possible scores range from 32-224, with a higher score indicating a better health-related quality of life.

  11. 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 ]
    Days of missed work or activity and reason why will be captured.

  12. 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 ]
    Number and type of healthcare resources utilized will be captured.

  13. Change in number of adverse events between the AVB-114 and standard of care groups. [ Time Frame: Day 1 to Week 104 ]
  14. Change in number of serious adverse events between the AVB-114 and standard of care groups. [ Time Frame: Day 1 to Week 104 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated ICF.
  2. Ability and willingness to comply with study protocol and study requirements for the duration of the study.
  3. Male or female, 18-70 years of age
  4. Subjects with CD diagnosed at least 6 months prior to screening visit.
  5. Subjects with a single fistula tract with one internal opening and one external opening, including a previously performed conversion of a branching fistula tract to a single fistula tract where the branching occurred outside the sphincter complex.
  6. 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.
  7. 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.

Exclusion Criteria:

  1. 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.
  2. Evidence of hepatitis B, C, or HIV or subjects with congenital or acquired immunodeficiencies.
  3. 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.
  4. History (within previous 5 years of screening visit) of invasive cancer including melanoma (with the exception of localized skin cancers).
  5. Subjects pregnant, trying to become pregnant, or are breast feeding.
  6. Subjects with contraindications to Magnetic Resonance (MR) evaluations and/or to MR contrast.
  7. History of clinically significant fat-directed autoimmunity.
  8. Concomitant recto-vaginal fistula
  9. Concomitant ileal anal pouch perineal fistulas.
  10. Active, unresolved infection requiring parenteral antibiotics.
  11. 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.
  12. 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.
  13. A compromised abdominal region due to a previous cool sculpting procedure, abdominal radiation, chemotherapy, recent tattoos, local infection, or other reasons that may compromise the adipose tissue for study use.
  14. Subjects previously treated with Cx601/Alofisel or other allogeneic or autologous stem-cell therapy within the past 6 months.
  15. Contraindications to the anesthetic procedure (local and general) or to the adipose tissue collection procedure.
  16. Subjects with one or more of the following fistula types or anatomic presentations:

    1. Horseshoe fistulas
    2. Fistulas that do not have an opening inside the anal canal or low rectum
    3. Blind ending sinus tracts (no external opening)
    4. Branching fistulas that involve or are near the sphincter complex and cannot be converted to single tracts without risk to injury to the sphincter complex
    5. >1 internal opening
    6. Moderate or severe proctitis
    7. Severe rectal mucosal fibrosis surrounding the internal opening preventing the securing of the fistula plug cap.
    8. Any anatomical limitation to successfully securing the fistula plug cap
  17. Evidence by colonoscopy of moderately or greater active luminal CD.
  18. Subject with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to screening and baseline study visits.
  19. History of, or concurrent high-grade dysplasia, adenocarcinoma, and carcinoma in situ on colonoscopy within 5 years of screening visit.
  20. Subjects with renal insufficiency (creatinine value > 1.8 mg/dL, eGFR < 44, or patient undergoing dialysis).
  21. Subjects with a hemoglobin less than 8 gm/dL.
  22. Subjects with serum aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the upper limit of normal (ULN).
  23. Subjects with undrained peri-anal sepsis.
  24. Subjects with known coagulopathy (abnormal INR) or thrombocytopenia as indicated by a platelet count < 75,000.
  25. Subjects with history of substance abuse (drug or alcohol) that would interfere with the ability to comply with the study protocol and study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847739


Contacts
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Contact: Louie Cabigao (226) 270-7868 STOMP2PM@alimentiv.com

Sponsors and Collaborators
Avobis Bio, LLC
Alimentiv Inc.
Investigators
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Study Director: Joan Morris Alimentiv Inc.
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Responsible Party: Avobis Bio, LLC
ClinicalTrials.gov Identifier: NCT04847739    
Other Study ID Numbers: STOMP-II
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avobis Bio, LLC:
Matrix plug
Mesenchymal stem cells
Fistula plug
Additional relevant MeSH terms:
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Crohn Disease
Rectal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases