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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Royal Perth Hospital
Sponsor:
Collaborators:
The Queen Elizabeth Hospital
Concord Hospital
Sir Charles Gairdner Hospital
The Alfred
Information provided by (Responsible Party):
R.P.Herrmann, Royal Perth Hospital
ClinicalTrials.gov Identifier:
NCT01090817
First received: March 22, 2010
Last updated: July 23, 2014
Last verified: July 2014

March 22, 2010
July 23, 2014
January 2010
June 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01090817 on ClinicalTrials.gov Archive Site
  • Incidence of infusional toxicity [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Crohn's disease activity index assessed as below 150
  • Improved quality of life [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Increase in IBDQ and SF-36 scores measured at six weeks
  • Endoscopic improvement. [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment
Incidence of infusional toxicity [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
 
An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease
A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn Disease
Drug: Mesenchymal stromal cells (MSC) for infusion
MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks
Other Name: No other names
Experimental: Mesenchymal stromal cells
Mesenchymal stromal cells administered weekly for 4 weeks
Intervention: Drug: Mesenchymal stromal cells (MSC) for infusion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2016
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact: Geoff Forbes, MD +61892243348 geoff.forbes@health.wa.gov.au
Australia
 
NCT01090817
EC2009/123, CTN2010/0098
Yes
R.P.Herrmann, Royal Perth Hospital
R.P.Herrmann
  • The Queen Elizabeth Hospital
  • Concord Hospital
  • Sir Charles Gairdner Hospital
  • The Alfred
Principal Investigator: Geoff Forbes, MD Royal Perth Hospital
Royal Perth Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP