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

Crohn Disease Clinical Trial

Official title:

A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090817
• Other study ID #: EC2009/123
• Secondary ID: CTN2010/0098
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2010
• Last updated: June 7, 2015
• Start date: January 2010
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Royal Perth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Mesenchymal stromal cells (MSC) for infusion
MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks

Locations

Country	Name	City	State
Australia	Department of Gastroenterology and Hepatology, Royal Perth Hospital	Perth	Western Australia

Sponsors (5)

Lead Sponsor	Collaborator
R.P.Herrmann	Concord Hospital, Sir Charles Gairdner Hospital, The Alfred, The Queen Elizabeth Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy	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.	Six weeks	No
Secondary	Incidence of infusional toxicity	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	Six weeks	Yes
Secondary	Induction of remission	Crohn's disease activity index assessed as below 150	Six weeks	No
Secondary	Improved quality of life	Increase in IBDQ and SF-36 scores measured at six weeks	Six weeks	No
Secondary	Endoscopic improvement.	Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment	Six weeks	No