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Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 52 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Jan 11, 2022, no change to tracked fieldsv51-v52
  2. Interventions: Placebo (Drug), adult human mesenchymal stem cells (Drug) to Placebo (Drug), Prochymal® (Drug)v50
  3. Re-verified, no change to tracked fieldsv49
  4. Lead sponsor: Mesoblast International Sàrl to Mesoblast, Inc. Start date: May 2007 to Sep 17, 2007 · Trial status: Active, Not Recruiting to Completed · Primary completion date changed from estimate of Jul 2018 to Sep 15, 2014 · 2 morev48 Show 5 more changesShow less
    • Start date: May 2007 to Sep 17, 2007
    • Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Jul 2018 to Sep 15, 2014
    • Study completion date changed from estimate of Jul 2020 to Sep 15, 2014
    • Eligibility criteria expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Dec 2016 to Jul 2018 Completion date: Dec 2018 to Jul 2020v47 Show 1 more changeShow less
    • Completion date: Dec 2018 to Jul 2020
Show 44 earlier versionsHide 44 earlier versions
  1. 2 versions Re-verified since May 19, 2015, no change to tracked fieldsv45-v46
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 65 to 56v44 Show 1 more changeShow less
    • Study sites: 65 to 56
  3. Lead sponsor: Osiris Therapeutics to Mesoblast International Sàrl Primary completion date: Jan 2014 to Dec 2016 · Enrollment target: 270 to 330 · Completion date: Dec 2015 to Dec 2018 · 2 morev43 Show 5 more changesShow less
    • Primary completion date: Jan 2014 to Dec 2016
    • Enrollment target: 270 to 330
    • Completion date: Dec 2015 to Dec 2018
    • Study title revised
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 2013 to Jan 2014v42
  5. Re-verified, no change to tracked fieldsv41
  6. Site details revised at 1 of 65 sitesv40
  7. Site details revised at 1 of 65 sites Eligibility criteria expanded, about 1 wordv39 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Primary completion date: Dec 2012 to Dec 2013 Completion date: Dec 2014 to Dec 2015v38 Show 1 more changeShow less
    • Completion date: Dec 2014 to Dec 2015
  9. Site details revised at 1 of 65 sitesv37
  10. Site details revised at 1 of 65 sitesv36
  11. Study sites: 64 to 65v35
  12. Study sites: 61 to 64v34
  13. Study sites: 60 to 61 Eligibility criteria shortened, about 1 wordv33 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  14. Primary completion date: Dec 2011 to Dec 2012 Completion date: Dec 2013 to Dec 2014v32 Show 1 more changeShow less
    • Completion date: Dec 2013 to Dec 2014
  15. Site details revised at 12 of 60 sitesv31
  16. Study sites revised (60)v30 See this version in full on ClinicalTrials.gov ↗
  17. Trial status: Active, Not Recruiting to Recruiting Study sites: 58 to 60v29 Show 1 more changeShow less
    • Study sites: 58 to 60
  18. Primary completion date: Jun 2009 to Dec 2011 Completion date: Dec 2011 to Dec 2013v28 Show 1 more changeShow less
    • Completion date: Dec 2011 to Dec 2013
  19. Trial status: Recruiting to Active, Not Recruiting Study sites: 60 to 58 · Primary completion date: Dec 2008 to Jun 2009 · Completion date: Mar 2009 to Dec 2011v27 Show 3 more changesShow less
    • Study sites: 60 to 58
    • Primary completion date: Dec 2008 to Jun 2009
    • Completion date: Mar 2009 to Dec 2011
  20. Site details revised at 1 of 60 sitesv26
  21. Site details revised at 4 of 60 sitesv25
  22. Site details revised at 1 of 60 sitesv24
  23. Study sites: 59 to 60v23
  24. Study sites: 58 to 59v22
  25. Study sites: 56 to 58v21
  26. Study sites: 54 to 56v20
  27. Study sites: 51 to 54v19
  28. Study sites: 48 to 51v18
  29. Study sites: 46 to 48v17
  30. Study sites: 44 to 46v16
  31. Study sites: 38 to 44v15
  32. Study sites: 37 to 38v14
  33. Study sites: 32 to 37v13
  34. Study sites: 26 to 32 Primary completion date: Dec 2008v12 Show 1 more changeShow less
    • Primary completion date: Dec 2008
  35. Study sites: 24 to 26v11
  36. Study sites: 18 to 24v10
  37. Study sites: 17 to 18 Interventions: adult human mesenchymal stem cells (Drug) to Placebo (Drug), adult human mesenchymal stem cells (Drug) · Study arms: 0 to 3v9 Show 2 more changesShow less
    • Interventions: adult human mesenchymal stem cells (Drug) to Placebo (Drug), adult human mesenchymal stem cells (Drug)
    • Study arms: 0 to 3
  38. Study sites: 13 to 17v8
  39. Study sites: 10 to 13v7
  40. Study sites: 8 to 10v6
  41. Enrollment target: 258 to 270 Study sites: 6 to 8 · Eligibility criteria expanded, about 7 wordsv5 Show 2 more changesShow less
    • Study sites: 6 to 8
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  42. Study sites: 4 to 6 Interventions: ex-vivo cultured adult human mesenchymal stem cells (Drug) to adult human mesenchymal stem cells (Drug) · Eligibility criteria expanded, about 13 wordsv4 Show 2 more changesShow less
    • Interventions: ex-vivo cultured adult human mesenchymal stem cells (Drug) to adult human mesenchymal stem cells (Drug)
    • Eligibility criteria expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  43. Study sites: 2 to 4v3
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Trial Details
NCT Number NCT00482092
Lead Sponsor Mesoblast, Inc.
Conditions Crohn's Disease
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov