Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease

Royan Institute1 site in 1 country10 target enrollmentFebruary 2013

ConditionsCrohn's Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: Royan Institute
Enrollment: 10
Locations: 1
Primary Endpoint: fistula closure
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in fistulizing Crohn's disease.

Detailed Description

In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A receives only autologous MSCs suspended in fibrin glue, group B receives autologous MSCs+ Fibroblasts. Both groups receive 4 injections inside the wall and lumen of the fistula. Injections will be repeated every month.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

February 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Royan Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1- Poor response to routine treatments in refractory Crohn's disease with fistula.
•2- CDAI\>220 3- Age 18 to 60 years 4- GFR\>30, Cr\<2 5- The presence of perinea fistula.