Overview

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:
Participant gender:
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
Details
Lead Sponsor:
Assistance Publique Hopitaux De Marseille