What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, especially those targeting perianal fistulas, include biologic therapies like infliximab and immunosuppressants such as methotrexate and azathioprine. Known side effects of these treatments can include increased risk of infections, infusion reactions, liver toxicity, and bone marrow suppression. Anti-TNF agents like infliximab may also cause injection site reactions, allergic reactions, and a potential increase in the risk of certain cancers. Methotrexate and azathioprine can lead to gastrointestinal upset, liver enzyme abnormalities, and, in rare cases, pancreatitis.

What prior FDA approvals exist?

FDA-approved treatments for Crohn's Disease, particularly for conditions similar to those targeted by AVB-114, include anti-TNF agents such as infliximab and adalimumab. These biologics are effective in treating fistulizing Crohn's Disease, including perianal fistulas. Additionally, immunomodulators like azathioprine and 6-mercaptopurine have been approved for managing Crohn's Disease. These treatments aim to reduce inflammation and promote healing of fistulas, similar to the investigational treatment AVB-114.

What other types of research exist?

Promising novel alternatives to AVB-114 for treating Crohn's perianal fistulas include: 1) Darvadstrocel, which has shown efficacy in achieving combined remission in patients with complex perianal fistulas. 2) AST-120, which has been effective in perianal fistula healing in patients with mild-to-moderate Crohn's disease. 3) Adalimumab, particularly for patients naive to anti-TNF therapy, has shown effectiveness in treating perianal fistulas. 4) Infliximab, which has demonstrated long-term efficacy in closing perianal fistulas and maintaining remission.

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Biological Therapy

Cell Therapy for Crohn's Disease

Phase 2

Waitlist Available

Research Sponsored by Avobis Bio, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, 18-70 years of age

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

Must not have

Genito-urinary fistulization, including rectovaginal (i.e., fistulae that transverse the vaginal canal)

Contraindications to the anesthetic procedure (local and general) or to the adipose tissue collection procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 to week 104

Awards & highlights

No Placebo-Only Group

Summary

This trial tests AVB-114, a new treatment using healing cells, for patients with hard-to-heal anal wounds from Crohn's disease. The treatment places these cells on a special patch to reduce inflammation and promote healing.

Who is the study for?

Adults aged 18-70 with Crohn's Disease who have a single perianal fistula that hasn't improved after biologic or conventional therapy, or if they've had an intolerance to these treatments. Women must not be pregnant and agree to use contraception; men with partners of childbearing potential must use barrier contraception.

What is being tested?

The trial is testing AVB-114 for treating complex Crohn's perianal fistulas compared to standard care. Part 1 involves initial treatment and control groups, while Part 2 allows those in the control group to receive AVB-114 after week 36, following the study protocol.

What are the potential side effects?

Specific side effects are not listed here, but generally, participants may experience risks associated with new medications like allergic reactions, infection risk due to immune system changes, discomfort at injection sites or from procedures involved in the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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My perianal fistula did not improve with previous treatments or I couldn't tolerate the medication.

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I have a fistula with one internal and one external opening.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a fistula involving my urinary or genital tracts.

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I am not allergic or unable to undergo anesthesia or fat tissue collection.

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I haven't had Cx601/Alofisel or stem-cell therapy in the last 6 months.

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I have an ileal anal pouch.

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I am currently on IV antibiotics for an ongoing infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 to week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 to week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in means of disease activity index scores using the Perianal Disease Activity Index (PDAI) between the AVB-114 and standard of care groups.

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.

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.

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care Treatment + AVB-114Experimental Treatment2 Interventions

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.

Group II: Standard of Care TreatmentActive Control1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease include anti-TNF agents, NSAIDs, and other biologics. Anti-TNF agents, such as infliximab and adalimumab, work by inhibiting tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. NSAIDs, like naproxen, reduce inflammation by inhibiting cyclooxygenase enzymes. Other biologics, such as ustekinumab, target interleukins like IL-12 and IL-23 to modulate the immune response. These treatments are crucial for managing inflammation and preventing complications. The investigational treatment AVB-114, used for Crohn's perianal fistulas, likely involves a novel mechanism aimed at promoting healing in fistulizing disease, which is significant for patients with refractory symptoms.

Choosing the right biologic for complications of inflammatory bowel disease.Location is important: differentiation between ileal and colonic Crohn's disease.Mongersen and SMAD-7 Inhibition, Not a Lucky 7 for Patients With IBD: When Trial Design Is as Important as Disease Therapy.