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

NCT01233960

NCT01233960
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must have already joined and signed consent forms for a related earlier study called "Protocol 603" after August 3, 2010.
  • You must have completed all the required check-up and screening steps in that earlier study (Protocol 603).
  • You must have successfully received all four of the treatment infusions given on Days 0, 3, 7, and 14 in the earlier study (Protocol 603), after August 3, 2010.
  • You must sign up for this trial on or before the 45th day after you received your first infusion in the earlier study.
  • You must sign new consent forms agreeing to take part in this trial and allowing your health information to be used.

Who may not be able to join:

  • You are not willing or able to follow the requirements of this trial.
  • You had confirmed breathing difficulties during any infusion of the study treatment (called PROCHYMAL) in any previous related study.
  • You had a serious health problem in any previous PROCHYMAL study that the study doctor believed was possibly or probably caused by PROCHYMAL, and that problem happened within 48 hours of receiving a PROCHYMAL infusion.

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 3: approximately ~65% 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 3
Sponsor
Mesoblast, Inc.
Registry
clinicaltrials_gov
Start date
29 November 2010
Est. completion
15 September 2014

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand 🇺🇸 United States

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

Primary endpoints

Disease remission

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