Cell Therapy for Crohn's Disease

Not currently recruiting at 19 trial locations

Overseen By Alimentiv Inc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Avobis Bio, LLC

Must not be taking: Steroids

Disqualifiers: Hepatitis, HIV, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy, AVB-114, to determine its safety and effectiveness in treating difficult cases of Crohn's disease affecting the area around the anus. The focus is on patients whose fistulas (abnormal connections between organs) have not improved with previous treatments. Participants will receive either the standard treatment or the new therapy to compare results. Those whose condition does not improve with the standard treatment may receive the new therapy later in the trial. This trial may suit individuals who have had Crohn's disease for at least six months, have a specific type of fistula, and have not responded to other treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic or rectal steroids for Crohn's disease, you must not have used them in the last 2 weeks before the screening and baseline study visits.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AVB-114, a treatment for Crohn's perianal fistulas, is safe. Studies have found that patients tolerate AVB-114 well. Importantly, no serious side effects linked to the treatment were reported. In a previous study, patients experienced significant healing without any major negative effects from the treatment. This suggests that AVB-114 is a promising and safe option for people with this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Unlike the standard treatments for Crohn's Disease, which often involve medications like corticosteroids and immunosuppressants, AVB-114 offers a different approach by using cell therapy. Researchers are excited about AVB-114 because it involves inserting a specially developed treatment directly into the affected area after removing a seton, which is part of the standard care. This method targets the condition locally and could potentially reduce inflammation and promote healing more effectively than systemic medications. The unique delivery of AVB-114 could lead to faster and more targeted relief for patients with Crohn's Disease.

What evidence suggests that AVB-114 could be an effective treatment for Crohn's perianal fistulas?

Research has shown that AVB-114, a treatment under study in this trial, may help treat complex Crohn's perianal fistulas. In one study, 45.8% of patients treated with AVB-114 experienced combined remission, compared to just 8.3% of those who received standard care, which involves seton placement. This significant difference suggests that AVB-114 can effectively reduce symptoms when other treatments have not worked. Additionally, another study found that 76% of patients stopped experiencing drainage 12 months after receiving AVB-114. These findings offer hope for patients whose fistulas have not improved with conventional therapy. ^{1 2 5 6 7}

Who Is on the Research Team?

Joan Morris

Principal Investigator

Alimentiv Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

WCBP participating in this study must agree to use an adequate method of contraception during the entire duration of the study

I was diagnosed with Crohn's disease more than 6 months ago.

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

Exclusion Criteria

I have a fistula involving my urinary or genital tracts.

Evidence of hepatitis B, C, or HIV or subjects with congenital or acquired immunodeficiencies

Subjects pregnant, trying to become pregnant, or are breast feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AVB-114 or standard of care treatment for Crohn's perianal fistulas

36 weeks

Regular visits as specified in the clinical protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

68 weeks

Open-label extension

Subjects in the control arm may receive AVB-114 treatment following week 36 and will be followed as specified in the clinical protocol

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• AVB-114
• Seton Placement

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of Care Treatment + AVB-114 Experimental Treatment 2 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 Treatment Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Avobis Bio, LLC

Lead Sponsor

Trials

2

Recruited

60+

Alimentiv Inc.

Collaborator

Trials

15

Recruited

3,300+

Published Research Related to This Trial

In a study involving 4 patients with moderate-severe refractory Crohn's disease, autologous hematopoietic stem cell transplantation (HSCT) using unselected peripheral blood stem cells (PBSCs) resulted in clinical remission for all patients by the third month, with significant improvement in disease activity scores.

The treatment was found to be safe, with no deaths or life-threatening infections reported, and 3 out of 4 patients maintained remission for over 16 months, indicating the potential long-term benefits of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous haematopoietic stem cell transplantation without CD34+ cell selection in refractory Crohn's disease. Cassinotti, A., Annaloro, C., Ardizzone, S., et al.[2022]

Citations

1. cgtlive.com cgtlive.com/view/avobis-bio-crohn-disease-cell-therapy-avb-114-garners-fda-rmat-designation

Avobis Bio's Crohn Disease Cell Therapy AVB-114 ... Notably, in STOMP-I, at 12 months post treatment, patients with persistent perianal Crohn disease showed 76% drainage cessation. Avobis also ...

2. biospace.com biospace.com/press-releases/avobis-bio-presents-positive-primary-analysis-results-from-the-randomized-multicenter-stomp2-clinical-trial-at-a-plenary-session-of-the-american-college-of-gastroenterologys-annual-scientific-meeting

Avobis Bio Presents Positive Primary Analysis Results from ... Combined remission was 8.3% (2/24) for SoC and 45.8% (11/24) for AVB-114 (38% difference, 95% confidence interval 11 – 60%, post hoc p-value = ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04847739

NCT04847739 | Seeded Cells on Matrix Plug Treating ... 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.

4. finance.yahoo.com finance.yahoo.com/news/avobis-bio-presents-positive-primary-172800845.html

Avobis Bio Presents Positive Primary Analysis Results from ... Combined remission was 8.3% (2/24) for SoC and 45.8% (11/24) for AVB-114 (38% difference, 95% confidence interval 11 – 60%, post hoc p-value = ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20515459

A Study to Analyze AVB-114 to Treat Complex Crohn's ... The purpose of this study is to determine whether AVB-114 compared to standard of care treatment is effective in inducing remission of the treated complex ...

6. pharmacytimes.com pharmacytimes.com/view/fda-grants-fast-track-designation-to-avb-114-for-crohn-disease-perianal-fistulas

FDA Grants Fast Track Designation to AVB-114 for Crohn ... The phase 1 STOMP-I trial showed AVB-114's safety and efficacy, with significant clinical healing and no treatment-related serious adverse ...

7. empr.com empr.com/news/implantable-stem-cell-therapy-fast-tracked-for-crohn-disease-perianal-fistulas/

Implantable Stem Cell Therapy Fast Tracked for Crohn ... Regarding safety, the 12-month analysis revealed none of the patients experienced a serious adverse event related to AVB-114. A phase 2 trial ( ...