Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease

Phase 1

• Conditions: Crohn's Disease
• Interventions: Biological: mesenchymal cell and fibroblast injection; Biological: mesenchymal cell transplantation

• Registration Number: NCT01874015
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesenchymal cell and fibroblast transplantaion	mesenchymal cell and fibroblast injection	The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.
mesenchymal cell transplantaion	mesenchymal cell transplantation	The patients with Crohn's disease who underwent mesenchymal cell transplantation.

Primary Outcome Measures

Name	Time	Method
fistula closure	4months	Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.

Secondary Outcome Measures

Name	Time	Method
CDAI	4months	Evaluation the decrease of CDAI after mesenchymal cell transplantation.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of