An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVF
Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Aug 11, 2015
Trial Information
Current as of July 22, 2025
Completed
Keywords
ClinConnect Summary
Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". Anoperineal lesions are a very frequent entity in this disease (20 to 80%) and a real therapeutic challenge. Among these lesions, we were interested in fistula-in-ano that are currently difficult to treat despite a large therapeutic arsenal.
Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.
Indeed, stem cells have shown some efficacy in several indications through their differentiation potential, inclu...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Disease of Crohn diagnosed for at least 6 months according to the recognized clinical, endoscopic and histological criteria
- • Presence of fistulas died anal complex estimated by clinical examination and MRI. A fistula died anal complex is, by definition, a fistula which answers at least one of the following criteria during its evolution: (1) high, trans-sphincter, extra-sphincter or above sphincter Inter-sphincter. (2) Presence of = 2 external openings. (3) Purulent Collections associated
- • Active or slightly active Crohn luminal, defined by a CDAI (Crohn's Disease Activity Index) = 220
- Exclusion Criteria:
- • - Disease of Crohn activates mainly luminal with a CDAI = 220 requiring an immediate treatment
- • Patients having never received specific treatments of the anal died disease of Crohn with fistula, including by antibiotics
- • Presence of an abscess or collections of more than 2 cms unless this problem is solved during the period of preparation
- • Rectal and/or anal Stenosis and/or active proctitis, if it means a limitation of the surgical procedure
- • Patient having undergone an operation of the fistula other than the drainage
- • Patients under corticoids or by having receiving in the previous four weeks
- • Active Malignant Tumors or history of Malignant tumors
About Assistance Publique Hopitaux De Marseille
Assistance Publique - Hôpitaux de Marseille (AP-HM) is a leading public healthcare institution in France, dedicated to providing high-quality medical care and advancing research in various clinical fields. As a prominent sponsor of clinical trials, AP-HM is committed to fostering innovation and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary approach, the institution collaborates with a network of healthcare professionals, researchers, and academic partners to facilitate cutting-edge studies that address critical health challenges. AP-HM's dedication to ethical standards and patient safety underscores its role as a trusted leader in clinical research and healthcare delivery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Marseille, , France
Patients applied
Trial Officials
Jean-Charles GRIMAUD, MD
Principal Investigator
Assistance Publique Hopitaux De Marseille
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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