Cell Therapy for Crohn's Disease

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment AVB-114, Seton Placement for Crohn's Disease?

Research shows that stem cell therapies, like those used in AVB-114, are promising for treating Crohn's Disease, especially in cases where other treatments have failed. Studies have shown that stem cell treatments can help patients achieve remission by reducing inflammation and promoting healing. ^{1 2 3 4 5}

Is cell therapy for Crohn's disease safe?

Research shows that local injections of mesenchymal stem cells (a type of cell therapy) for Crohn's disease are generally safe, with only 1% of patients experiencing treatment-related side effects, and no severe side effects reported over a 6-month period. ^{1 6 7 8 9}

Research Team

Joan Morris

Principal Investigator

Alimentiv Inc.

Eligibility Criteria

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.

I am between 18 and 70 years old.

Exclusion Criteria

I have a fistula involving my urinary or genital tracts.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Autologous haematopoietic stem cell transplantation without CD34+ cell selection in refractory Crohn's disease. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Stem cell-based therapies in inflammatory bowel disease: promises and pitfalls. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Current status of mesenchymal stem cell therapy and bone marrow transplantation in IBD. [2018]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Cell therapies for IBD: what works? [2021]

5. England pubmed.ncbi.nlm.nih.gov

Stem cell therapy for Crohn's disease: systematic review and meta-analysis of preclinical and clinical studies. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Systematic review with meta-analysis: Safety and efficacy of local injections of mesenchymal stem cells in perianal fistulas. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells for the treatment of complex perianal fistula in Crohn's disease: a pilot study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Improving safety of autologous haematopoietic stem cell transplantation in patients with Crohn's disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Generation of 3 clones of induced pluripotent stem cells (iPSCs) from a patient affected by Crohn's disease. [2020]