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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 April 2014
Main ID:  NCT01090817
Date of registration: 22/03/2010
Primary sponsor: R.P.Herrmann
Public title: An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease
Scientific title: A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease
Date of first enrolment: January 2010
Target sample size: 20
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01090817
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: Mesenchymal stromal cells (MSC) for infusion
Primary Outcome(s)
Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy [Time Frame: Six weeks]
Secondary Outcome(s)
Endoscopic improvement. [Time Frame: Six weeks]
Improved quality of life [Time Frame: Six weeks]
Incidence of infusional toxicity [Time Frame: Six weeks]
Induction of remission [Time Frame: Six weeks]
Secondary ID(s)
CTN2010/0098
EC2009/123
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Concord Hospital
Sir Charles Gairdner Hospital
The Alfred
The Queen Elizabeth Hospital
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