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Historical Analysis of Changes to Capricor Therapeutics Phase 1/2 Stem Cell Clinical Trial NCT01458405:
Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (ALLSTAR)
Synopsis (excepted from ClinicalTrials.gov): The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.

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

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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10/21
2011
n/aNYR-------First recordGreen Flag - No Issues
7/10
2012
8/31
2015
NYR22-----Green Flag - No Issues
10/26
2012
10/31
2015
Rec211----Green Flag - No Issues
11/13
2012
10/31
2015
Rec2-2----Green Flag - No Issues
8/8
2013
10/31
2015
Rec2-2----Immaterial changesGreen Flag - No Issues
2/18
2014
10/31
2015
Rec3-3----Green Flag - No Issues
NOTE: As of today (Aug 20, 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