Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease
Recruiting
Phase 1
Phase 2
Interventional Study
Crohn Disease (CD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 25 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Other
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About This Trial
The ADICROHN-3 study is a prospective, multicenter, open-label cohort study.
Its design is supported by the following elements:
* The results of the ADICROHN pilot study (EudraCT No. 2013-002602-31) and our 3-year study, which demonstrate an excellent safety profile with a promising efficacy signal.
* Data from the literature confirming that cryopreservation of FVS does not compromise the clonog…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* (1) Signing of a consent form.
* (2) Patients with Crohn's disease diagnosed at least 6 months prior, in accordance with clinical, endoscopic, histological, and/or radiological criteria.
* (3) Patients previously enrolled in or treated as part of the ADICROHN 2 study.
* (4) No…
Contacts
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