Crohn's Disease Clinical Trial
Official title:
Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | February 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fistula closure | Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease. | 4months | |
Secondary | CDAI | Evaluation the decrease of CDAI after mesenchymal cell transplantation. | 4months |
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