Crohn DiseasePhase 2NCT01090817
An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease
A Phase 2 study testing Mesenchymal stromal cells (MSC) for infusion in people with Crohn Disease, run by R.P.Herrmann at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Mesenchymal stromal cells (MSC) for infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2010to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Department of Gastroenterology and Hepatology, Royal Perth Hospital
Perth, Western Australia, 6000
About this study
Official title: A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease
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
- Being tested
- Mesenchymal stromal cells (MSC) for infusion
- Keywords
- mesenchymal stromal cells, ileitis, colitis
- Medical subject headings
- Crohn Disease, Ileitis, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stromal cells (MSC) for infusionDrug
Also called No other names
MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stromal cells | Experimental | Mesenchymal stromal cells administered weekly for 4 weeks Receives: Drug: Mesenchymal stromal cells (MSC) for infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks
Secondary outcomes (4)
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
Measured: Six weeks
Induction of remission
Crohn's disease activity index assessed as below 150
Measured: Six weeks
Improved quality of life
Increase in IBDQ and SF-36 scores measured at six weeks
Measured: Six weeks
Endoscopic improvement.
Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- R.P.Herrmann
- Sponsor type
- University, hospital or other
- Collaborators
- The Queen Elizabeth Hospital, Concord Hospital, Sir Charles Gairdner Hospital, The Alfred
- Responsible party
- Sponsor-investigator, R.P.Herrmann, Royal Perth Hospital
- Investigators
- Geoff Forbes, MD, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090817
- Sponsor's protocol ID
- EC2009/123
- Other IDs
- CTN2010/0098
- Status last verified
- Jun 2015
- First submitted
- 22 Mar 2010
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23872668
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease
- ClinicalTrials.gov ID
- NCT01090817
- Acronym / sponsor ID
- EC2009/123
- Conditions
- Crohn Disease
- Keywords
- mesenchymal stromal cells, ileitis, colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- R.P.HerrmannUniversity, hospital or other
- Collaborators
- The Queen Elizabeth Hospital, Concord Hospital, Sir Charles Gairdner Hospital, The Alfred
- Study start
- Jan 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stromal cells | Experimental | Drug: Mesenchymal stromal cells (MSC) for infusionMesenchymal stromal cells administered weekly for 4 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stromal cells (MSC) for infusionAlso: No other namesMSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks | Drug | Mesenchymal stromal cells |
Primary outcome
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.
4 secondary outcomes
Incidence of infusional toxicity
Time frame: Six weeks
Induction of remission
Time frame: Six weeks
Improved quality of life
Time frame: Six weeks
Endoscopic improvement.
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Derived from this study: PubMed 23872668Forbes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoff Forbes, MD principal investigator
Royal Perth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stromal cells (MSC) for infusion in people with Crohn Disease, run by R.P.Herrmann at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.