NCT02520843

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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, including fistula-in-ano in Crohn's disease. 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 Microaspiration is performed by a plastic surgeon under general anesthesia. He performs two types of fat removal : a sample of 120 cc wich is sent to the laboratory of cell therapy to obtain the SVF (5 cc) and a sample of 30 cc. Once treatment obtained (SVF + adipose tissue) it is administered to the patient by local mico reinjection into (SVF) and around (adipose tissue) of the fistula. This administration is made by the surgeon under a second general anesthesia after viewing the fistula and removal of setons. Then the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate tolerance and effectiveness of treatment. At the end of the study, results that are expected are effectiveness of local micro reinjection of autologous adipose tissue and SVF for the treatment of refractory fistula-in-ano in Crohn's disease.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	stromal vascular fraction (SVF)	stromal vascular fraction (SVF) is administered to the patient suffering of Refractory Crohn's disease around of the fistula by local mico injection

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2015-08-13
• Last updated: 2019-01-17

Locations

1 site across 1 country: France