Crohn's Disease
Conditions
Keywords
Crohn's disease, mesenchymal stem cell, fistula
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.
Interventions
BIOLOGICALmesenchymal cell transplantation
Mesenchymal cell transplantation in patients with Crohn's disease.
BIOLOGICALmesenchymal cell and fibroblast injection
Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.
Sponsors
Royan Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fistula closure | 4months | Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CDAI | 4months | Evaluation the decrease of CDAI after mesenchymal cell transplantation. |
Countries
Iran
Contacts
Primary ContactNasser Aghdami, MD,PhD
Backup ContactLeila Arab, MD
Outcome results
None listed