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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Mesenchymal cell transplantation in patients with Crohn's disease.
Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.
Royan Institute
Tehran, Iran
RECRUITINGfistula closure
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
Time frame: 4months
CDAI
Evaluation the decrease of CDAI after mesenchymal cell transplantation.
Time frame: 4months
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