An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT01090817
• Date of registration: 22/03/2010
• Prospective Registration: No
• 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: 21
• Recruitment status: Completed
• 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
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Geoff Forbes, MD
• Affiliation: Royal Perth Hospital

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)

Induction of remission [Time Frame: Six weeks]

Endoscopic improvement. [Time Frame: Six weeks]

Improved quality of life [Time Frame: Six weeks]

Incidence of infusional toxicity [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)

The Alfred

Sir Charles Gairdner Hospital

Concord Hospital

The Queen Elizabeth Hospital