Crohn Disease
Conditions
Keywords
mesenchymal stromal cells, ileitis, colitis
Brief summary
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
Interventions
DRUGMesenchymal stromal cells (MSC) for infusion
MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks
Sponsors
The Queen Elizabeth Hospital
Concord Hospital
Sir Charles Gairdner Hospital
The Alfred
R.P.Herrmann
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Colonic or small bowel Crohn's disease based on endoscopic appearances and histology * Refractory to induction with infliximab or adalimumab; or have lost response to these agents; or have had side effects precluding their further use * Where there has been loss of response to one of these agents, the other must be tried before being eligible * Crohn's disease activity score (CDAI) 250 or more. * C-reactive protein \>10mg/L * Surgery must have been offered to the subject (if appropriate) and declined * Signed informed consent
Exclusion criteria
* Active sepsis, perforating disease. Coexistent perianal fistulous disease is permitted, providing no co-existent infection within previous 4 weeks * Chronic stricturing disease in isolation * Coexistent CMV disease * Prior history of malignancy * Pregnant or unwilling to practice contraceptive therapy or breast feeding females * Last biologic therapy must be greater than 4 weeks prior, must be on stable corticosteroid dose for 14 days prior, during therapy and for 14 days after therapy, must be on stable immunomodulator dose (eg, azathioprine) for 14 days prior, during therapy and for 14 days after.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy | Six weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infusional toxicity | Six weeks | 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 |
| Induction of remission | Six weeks | Crohn's disease activity index assessed as below 150 |
| Improved quality of life | Six weeks | Increase in IBDQ and SF-36 scores measured at six weeks |
| Endoscopic improvement. | Six weeks | Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment |
Countries
Australia
Outcome results
None listed