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Historical Analysis of Changes to Osiris Therapeutics Phase 3 Stem Cell Clinical Trial NCT01233960:
Evaluation of PROCHYMAL for Treatment-refractory Moderate-to-severe Crohn's Disease
Synopsis (excepted from ClinicalTrials.gov): To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's disease therapies. Subjects will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells.

Issues Summary:   Potential major issue(s) detected - see table below

Trial-Related Publications: n/a

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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11/2
2010
9/30
2012
Rec4-4----First recordGreen Flag - No Issues
2/8
2011
9/30
2012
Rec14-14----Immaterial changesGreen Flag - No Issues
10/6
2011
9/30
2012
Rec14-14----Immaterial changesGreen Flag - No Issues
1/11
2012
12/31
2012
Rec16-16----Green Flag - No Issues
2/13
2012
12/31
2012
Rec19-19----Green Flag - No Issues
5/15
2012
12/31
2012
Rec20-20----Green Flag - No Issues
11/2
2012
12/31
2012
Rec20-19-1--Green Flag - No Issues
11/21
2012
12/31
2012
Rec20-18-2--Green Flag - No Issues
1/28
2013
12/31
2013
Rec20-18-2--Last follow-up date extended 12 months. Second extension of primary completion date (ex post facto), in aggregate totaling 1+ yearsRed Flag - Serious Issue?
4/30
2013
12/31
2013
Rec20-17-3--Green Flag - No Issues
10/28
2013
12/31
2013
Rec20-17-3--Immaterial changesGreen Flag - No Issues
1/15
2014
1/31
2014
Rec20-17-3--Anticipated primary completion date (Jan 2014) is unfeasible given current status (recruiting) and primary endpoint time frame (180 days post-treatment)Yellow Flag - Minor Issue?
NOTE: As of today (Jan 21, 2019) this trial’s record has not been updated by the sponsor in 5+ years. The trial’s current status is therefore questionable.Red Flag - Serious Issue?

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* Status abbreviations:
NYR: not yet recruiting   Sus: suspended
Rec: recruiting   Ter: terminated
ANR: active, not recruiting   Unk: unknown
Com: completed

** Flags are assigned by our automated analysis to indicate the relative potential of each recorded change to suggest a possible set-back or problem for the trial. They are intended as aids to the scanning of these records, not as predictions regarding the success or failure of a clinical trial.

 No negative implications for this change
 Potentially minor negative implications for this change
 Potentially significant negative implications for this change
n/a: Flags are not assigned to changes dated subsequent to trial completion or termination.

Examples of events that may be viewed as having potentially negative implications include (but are not limited to):

  • Suspension of a trial
  • No record updates for > 1 year
  • Inclusion late in a trial of an additional patient cohort with much less severe disease
  • Significant liberalization of inclusion/exclusion criteria late in a trial
  • Unusually slow rate of progression of trial sites status from "Not yet recruiting" to "Recruiting"
  • Significant over-run of Estimated Primary Completion Date
  • Termination or deletion of a significant fraction of trial sites