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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2015 (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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090817

Contacts
Contact: Geoff Forbes, MD +61892243348 geoff.forbes@health.wa.gov.au

Locations
Australia, Western Australia
Department of Gastroenterology and Hepatology, Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Geoff Forbes, MD    +61892242171    geoff.forbes@health.wa.gov.au   
Sub-Investigator: Richard P Herrmann, MB, BS         
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

No publications provided by Royal Perth Hospital

Additional 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
Study First Received: March 22, 2010
Last Updated: July 23, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014