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

Royan Institute

Status and phase: Unknown; Phase 1

Conditions: Crohn's Disease

Treatments: Biological: mesenchymal cell transplantation; Biological: mesenchymal cell and fibroblast injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01874015

Royan-GI-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

mesenchymal cell and fibroblast transplantaion

Active Comparator group

Description:

The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.

Treatment:

Biological: mesenchymal cell and fibroblast injection

mesenchymal cell transplantaion

Active Comparator group

Description:

The patients with Crohn's disease who underwent mesenchymal cell transplantation.

Treatment:

Biological: mesenchymal cell transplantation