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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090817
First Posted: March 23, 2010
Last Update Posted: June 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Queen Elizabeth Hospital
Concord Hospital
Sir Charles Gairdner Hospital
The Alfred
Information provided by (Responsible Party):
R.P.Herrmann, Royal Perth Hospital
  Purpose
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

Condition Intervention Phase
Crohn Disease Drug: Mesenchymal stromal cells (MSC) for infusion Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease

Resource links provided by NLM:


Further study details as provided by R.P.Herrmann, Royal Perth Hospital:

Primary Outcome Measures:
  • 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 ]
    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 Outcome Measures:
  • Incidence of infusional toxicity [ Time Frame: 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 [ Time Frame: Six weeks ]
    Crohn's disease activity index assessed as below 150

  • Improved quality of life [ Time Frame: Six weeks ]
    Increase in IBDQ and SF-36 scores measured at six weeks

  • Endoscopic improvement. [ Time Frame: Six weeks ]
    Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment


Enrollment: 21
Study Start Date: January 2010
Study Completion Date: June 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal stromal cells
Mesenchymal stromal cells administered weekly for 4 weeks
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090817


Locations
Australia, Western Australia
Department of Gastroenterology and Hepatology, Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
R.P.Herrmann
The Queen Elizabeth Hospital
Concord Hospital
Sir Charles Gairdner Hospital
The Alfred
Investigators
Principal Investigator: Geoff Forbes, MD Royal Perth Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: R.P.Herrmann, Director Cell and Tissue Therapies Western Australia, Royal Perth Hospital
ClinicalTrials.gov Identifier: NCT01090817     History of Changes
Other Study ID Numbers: EC2009/123
CTN2010/0098 ( Other Identifier: Therapeutics Good Administration, Government of Australia )
First Submitted: March 22, 2010
First Posted: March 23, 2010
Last Update Posted: June 9, 2015
Last Verified: June 2015

Keywords provided by R.P.Herrmann, Royal Perth Hospital:
mesenchymal stromal cells
ileitis
colitis

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases