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

NCT02520843 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-01-17

No results posted yet for this study

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

Conditions

  • Crohn Disease

Interventions

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

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Jean-Charles GRIMAUD, MD · Assistance Publique Hopitaux De Marseille

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520843 on ClinicalTrials.gov