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| ID | Type | Description | Link |
|---|---|---|---|
| CTN2010/0098 | Other Identifier | Therapeutics Good Administration, Government of Australia |
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| Name | Class |
|---|---|
| The Queen Elizabeth Hospital | OTHER |
| Concord Hospital | OTHER |
| Sir Charles Gairdner Hospital | OTHER |
| The Alfred |
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Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using third party human cultured cells will be safe and effective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stromal cells | Experimental | Mesenchymal stromal cells administered weekly for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stromal cells (MSC) for infusion | Drug | MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy | Colonoscopy and biopsy as well as clinical parameters used for the Crohn's disease acivity (www.ibdaustralia.org/cdai/) will be undertaken at screening pre-therapy and at 6 weeks after start of therapy. | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infusional toxicity | Subjects will receive mesenchymal stromal cell therapy, 2X10E6/kg weekly by IV infusion for 4 weeks and will be assessed for 4 hours post infusion | Six weeks |
| Induction of remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoff Forbes, MD | Royal Perth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology, Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23872668 | Derived | Forbes GM, Sturm MJ, Leong RW, Sparrow MP, Segarajasingam D, Cummins AG, Phillips M, Herrmann RP. A phase 2 study of allogeneic mesenchymal stromal cells for luminal Crohn's disease refractory to biologic therapy. Clin Gastroenterol Hepatol. 2014 Jan;12(1):64-71. doi: 10.1016/j.cgh.2013.06.021. Epub 2013 Jul 19. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D007079 | Ileitis |
| D003092 | Colitis |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
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|
Crohn's disease activity index assessed as below 150
| Six weeks |
| Improved quality of life | Increase in IBDQ and SF-36 scores measured at six weeks | Six weeks |
| Endoscopic improvement. | Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment | Six weeks |
| D007410 | Intestinal Diseases |
| D004751 | Enteritis |
| D007077 | Ileal Diseases |
| D003108 | Colonic Diseases |