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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01090817

NCT01090817
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have Crohn's disease affecting the large bowel (colon) or small bowel, confirmed by camera examination (endoscopy) and tissue samples (biopsy)
  • You have tried the biologic medicines infliximab or adalimumab, but they stopped working, caused side effects that prevented continued use, or never worked for you
  • If one of these biologic medicines stopped working, you must have also tried the other one before being eligible
  • Your Crohn's disease is currently quite active, measured by a scoring system called the CDAI (score of 250 or above)
  • A blood test shows a raised level of inflammation in your body (C-reactive protein above 10mg/L)
  • Surgery has been discussed with you as an option and you have chosen not to have it (if surgery was considered appropriate for your situation)
  • You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • You currently have an active infection or a hole/tear in your bowel (perforating disease) — though anal fistulas are allowed, as long as there has been no related infection in the past 4 weeks
  • Your Crohn's disease causes only narrowing (strictures) of the bowel, with no other features
  • You have an active CMV (cytomegalovirus) infection alongside your Crohn's disease
  • You have a history of cancer at any point in the past
  • You are pregnant, breastfeeding, or not willing to use contraception during the trial
  • Your last biologic medicine was taken less than 4 weeks ago, or your steroid or immunosuppressant doses (such as azathioprine) have not been stable for at least 14 days before, during, and after treatment (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
R.P.Herrmann
Registry
clinicaltrials_gov
Start date
1 January 2010
Est. completion
1 June 2014

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov