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.
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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…
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