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Search / Trial NCT02520843

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.

Locations

Marseille, , France

Patients applied

0 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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