Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
Published: 10/13/2021
General Information:
Primary: To determine whether AVB-114 compared to standard of care treatment is effective in inducing remission of the treated complex perianal fistula in patients with Crohn’s Disease.
Secondary: To assess clinical and radiologic components of fistula remission, safety of treatment, disease activity, patient Quality of Life, and patient care journey, between AVB-114 and standard of care treatment.
Eligibility:
- You may be able to participate in the STOMP-2 Study if you meet the following key inclusion criteria*:
- Male or female, 18-70 years of age
- Crohn's disease diagnosed at least 6 months prior to screening visit
- A single fistula tract with one internal opening and one external opening, and that crosses the anorectal musculature ("complex")
- Previously treated with either biologic or conventional therapy whose fistula has demonstrated a failed response or who have documented medication intolerance
- You will not be able to participate in the STOMP-2 Study if you meet any of the following key exclusion criteria*:
- Additional/multiple fistulas
- Unable to undergo the anesthetic procedure (local and general) or to the adipose tissue collection procedure
- Moderate or severe proctitis
- Evidence by colonoscopy of moderately or greater active luminal Crohn's disease
- Ongoing systemic or rectal steroids for Crohn's disease
- Undrained peri-anal sepsis
*Other inclusion and exclusion criteria apply
Study Details:
Study Description:
Study intervention begins with collection of a small piece of fat (about the size of an olive, similar to a biopsy) from your abdomen or thigh which will be used to create the study treatment (AVB-114, a stem cell therapy). Following preliminary treatment of your fistula, you will be randomly assigned to either standard of care treatment (control) or AVB-114 treatment. If you decide to take part, your participation may last up to 28 months (112 weeks). If you are randomized to the standard of care treatment group, at Week 36 post-treatment you may elect to receive AVB-114 treatment if deemed eligible by the study doctor (and would subsequently be followed for 52 weeks post- AVB-114 treatment).
Description of treatment or intervention (mechanism of action):
Stem cells function to regulate the immune and inflammatory systems in response to their microenvironment and have been extensively studied in human clinical trials. It is hypothesized that growing a patient's own stem cells with a bioabsorbable scaffold (non-permanent / dissolves by the body) and subsequently tailoring the product intraoperatively to the patient's fistula geometry may promote healing and closure of the fistula. The therapy is experimental and has not been proven safe or effective.
Patient Participation Requirements:
Participants will be asked to provide their medical and surgical history. The study requires several clinic visits where clinical examination, blood sampling, magnetic resonance imaging (MRI), medication review, and completion of quality of life and symptom questionnaires will occur. Exam under anesthesia will be required during screening, day 0 treatment, and as deemed necessary by the study doctor. Participants will be in this study for up to 28 months.
Possible risks and side effects:
In a Phase I clinical trial, no adverse events were attributed to AVB-114 although 2 adverse events were related to fat collection (1 occurrence of biopsy site reopening and stitch infection, 1 occurrence of biopsy site stitch fluid build-up). AVB-114 is still being studied so not all adverse effects are known, and as with any clinical trial there is the potential for adverse effects.