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

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Mesenchymal stromal cells (MSC) for infusion
Sponsored by
R.P.Herrmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring mesenchymal stromal cells, ileitis, colitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Gastroenterology and Hepatology, Royal Perth Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal stromal cells

Arm Description

Mesenchymal stromal cells administered weekly for 4 weeks

Outcomes

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
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
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
Crohn's disease activity index assessed as below 150
Improved quality of life
Increase in IBDQ and SF-36 scores measured at six weeks
Endoscopic improvement.
Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment

Full Information

First Posted
March 22, 2010
Last Updated
June 7, 2015
Sponsor
R.P.Herrmann
Collaborators
The Queen Elizabeth Hospital, Concord Hospital, Sir Charles Gairdner Hospital, The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT01090817
Brief Title
An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease
Official Title
A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
R.P.Herrmann
Collaborators
The Queen Elizabeth Hospital, Concord Hospital, Sir Charles Gairdner Hospital, The Alfred

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
mesenchymal stromal cells, ileitis, colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stromal cells
Arm Type
Experimental
Arm Description
Mesenchymal stromal cells administered weekly for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Mesenchymal stromal cells (MSC) for infusion
Other Intervention Name(s)
No other names
Intervention Description
MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks
Primary Outcome Measure Information:
Title
Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy
Description
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.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Incidence of infusional toxicity
Description
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
Time Frame
Six weeks
Title
Induction of remission
Description
Crohn's disease activity index assessed as below 150
Time Frame
Six weeks
Title
Improved quality of life
Description
Increase in IBDQ and SF-36 scores measured at six weeks
Time Frame
Six weeks
Title
Endoscopic improvement.
Description
Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoff Forbes, MD
Organizational Affiliation
Royal Perth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology and Hepatology, Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23872668
Citation
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.
Results Reference
derived

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

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