Expanded access to AVB-114 for prior STOMP-II patients
Part of Digestive system, Immune system & allergy clinical trials.
This study provides access to an experimental treatment (AVB-114) for people with Crohn's disease who have an anal fistula and who were previously part of the STOMP-II study but could not get the treatment. The treatment uses fat-derived cells to help heal the fistula, and the goal is to give these patients a chance to receive it.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must have already had fat tissue collected as part of the STOMP-II study, but you were not able to receive the AVB-114 treatment because of a screening issue or a problem with the product.
- You must have Crohn's disease with a perianal fistula that has one opening inside the anal canal and at least one opening on the skin.
- You must sign a consent form to participate.
- You cannot be pregnant, trying to get pregnant, or breastfeeding (and must use birth control if you could become pregnant).
- You must not have allergies to aminoglycoside antibiotics, a history of fat-directed autoimmunity, or an active infection requiring intravenous antibiotics.
- Any abscess seen on an MRI must be drained and resolved before treatment, and your fistula must be of a type that can be safely treated with the plug.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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