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

StatusCompleted
PhasePhase 3
Started

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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.v48 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
  5. Primary completion date: Dec 2016 to Jul 2018
    • Study completion date: Dec 2018 to Jul 2020
    v47
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 56
    v44
  3. Lead sponsor: Osiris Therapeutics to Mesoblast International Sàrlv43 Show 5 more changesShow less
    • Primary completion date: Jan 2014 to Dec 2016
    • Enrollment target: 270 to 330
    • Study completion date: Dec 2015 to Dec 2018
    • Study title revised
    • Study description shortened, about 1 word
  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 word
    v39
  8. Primary completion date: Dec 2012 to Dec 2013
    • Study completion date: Dec 2014 to Dec 2015
    v38
  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 word
    v33
  14. Primary completion date: Dec 2011 to Dec 2012
    • Study completion date: Dec 2013 to Dec 2014
    v32
  15. Site details revised at 12 of 60 sitesv31
  16. Study sites revised (60)v30
  17. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 58 to 60
    v29
  18. Primary completion date: Jun 2009 to Dec 2011
    • Study completion date: Dec 2011 to Dec 2013
    v28
  19. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 60 to 58
    • Primary completion date: Dec 2008 to Jun 2009
    • Study completion date: Mar 2009 to Dec 2011
    v27
  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 2008
    v12
  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 3
    v9
  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 words
    v5
  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 words
    v4
  43. Study sites: 2 to 4v3
  • 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
(from sponsor)		 Crohn's Disease
Related terms Crohn Disease
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov