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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal cell and fibroblast transplantaion | Active Comparator | The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection. |
|
| mesenchymal cell transplantaion | Active Comparator | The patients with Crohn's disease who underwent mesenchymal cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal cell transplantation | Biological | Mesenchymal cell transplantation in patients with Crohn's disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| fistula closure | Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease. | 4months |
| Measure | Description | Time Frame |
|---|---|---|
| CDAI | Evaluation the decrease of CDAI after mesenchymal cell transplantation. | 4months |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasser Aghdami, MD,PhD | Contact | +9823562000 | 504 | nasser.aghdami@royaninstitute.org |
| Leila Arab, MD | Contact | +9823562000 | 414 | Leara91@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Nasser Aghdami, MD,PhD | Head of Royan department of degenerative medicine,Head of Royan celltherapy center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Recruiting | Tehran | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D045164 | Mesenchymal Stem Cell Transplantation |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
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| mesenchymal cell and fibroblast injection | Biological | Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease. |
|
| Mahdi Mohammad Nejhad, MD |
| TUMS DDRI |
| Study Director |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |