NCT01874015

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	mesenchymal cell transplantation	Mesenchymal cell transplantation in patients with Crohn's disease.
BIOLOGICAL	mesenchymal cell and fibroblast injection	Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-12-01
• Completion: 2018-02-01
• First posted: 2013-06-10
• Last updated: 2017-04-27

Locations

1 site across 1 country: Iran