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

NCT ID: NCT01090817

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-06-30

Brief 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

Conditions

Crohn Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesenchymal stromal cells

Mesenchymal stromal cells administered weekly for 4 weeks

Group Type: EXPERIMENTAL

Mesenchymal stromal cells (MSC) for infusion

Intervention Type: DRUG

MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks

Interventions

Mesenchymal stromal cells (MSC) for infusion

MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks

Intervention Type: DRUG

Other Intervention Names

No other names

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Queen Elizabeth Hospital

OTHER

Sponsor Role: collaborator

Concord Hospital

OTHER

Sponsor Role: collaborator

Sir Charles Gairdner Hospital

OTHER

Sponsor Role: collaborator

The Alfred

OTHER

Sponsor Role: collaborator

R.P.Herrmann

OTHER

Sponsor Role: lead

Responsible Party

R.P.Herrmann

Director Cell and Tissue Therapies Western Australia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Geoff Forbes, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Perth Hospital

Locations

Department of Gastroenterology and Hepatology, Royal Perth Hospital

Perth, Western Australia, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 23872668 (View on PubMed)

Other Identifiers

CTN2010/0098

Identifier Type: OTHER

Identifier Source: secondary_id

EC2009/123

Identifier Type: -

Identifier Source: org_study_id