Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Royan Institute
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- fistula closure
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
mesenchymal cell and fibroblast transplantaion
The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.
Intervention: mesenchymal cell and fibroblast injection (Biological)
mesenchymal cell transplantaion
The patients with Crohn's disease who underwent mesenchymal cell transplantation.
Intervention: mesenchymal cell transplantation (Biological)
Outcomes
Primary Outcomes
fistula closure
Time Frame: 4months
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
Secondary Outcomes
- CDAI(4months)