An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVF

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". .

Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.

Adipose tissue seems to be an ideal source for cell therapy. This is a prospective, open, non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and will be conducted over a period of 28 month.

This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, the safety and efficacy of local microinjection of autologous adipose tissue and SVF from microaspirate .

The main objective is to assess tolerance and security. The secondary objective is to evaluate the effectiveness of this technique

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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