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Historical Analysis of Changes to NeoStem Phase 2 Stem Cell Clinical Trial NCT01495364:
AMR-001 Versus Placebo Post ST Segment Elevation Myocardial Infarction (PreSERVE-AMI)
Synopsis (excepted from ClinicalTrials.gov): This study will assess the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial infarction (STEMI). Efficacy will be assessed by evaluating and comparing the autologous stem cell treatment group to the control group via change in myocardial perfusion (RTSS) measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging (gated SPECT MPI) among other secondary endpoints measured by cardiac MRI in addition to clinical endpoints.

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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12/19
2011
7/31
2013
NYR-------First recordGreen Flag - No Issues
1/4
2012
7/31
2013
Rec1-1----Green Flag - No Issues
2/9
2012
7/31
2013
Rec4-4----Green Flag - No Issues
2/21
2012
7/31
2013
Rec6-6----Green Flag - No Issues
3/29
2012
7/31
2013
Rec14-14----Green Flag - No Issues
4/19
2012
7/31
2013
Rec17-17----Green Flag - No Issues
5/7
2012
7/31
2013
Rec19-19----Green Flag - No Issues
5/23
2012
7/31
2013
Rec23-23----Green Flag - No Issues
7/11
2012
7/31
2013
Rec28-28----Green Flag - No Issues
9/13
2012
7/31
2013
Rec35-35----Minor changes to inclusion and exclusion criteriaGreen Flag - No Issues
12/11
2012
7/31
2013
Rec45-45----Green Flag - No Issues
2/11
2013
12/31
2013
Rec53-53----Minor changes to inclusion and exclusion criteriaGreen Flag - No Issues
3/1
2013
12/31
2013
Rec56-56----Green Flag - No Issues
5/2
2013
12/31
2013
Rec57-57----Green Flag - No Issues
6/12
2013
12/31
2013
Rec59-57---2Multiple sites withdrawn, terminated, or suspendedYellow Flag - Minor Issue?
8/8
2013
12/31
2013
Rec61-58---3Continuing site withdrawals. Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (6 months post-treatment)Red Flag - Serious Issue?
12/16
2013
6/30
2014
ANR61-58---3Second extension of primary completion date.Green Flag - No Issues
12/19
2013
6/30
2014
ANR61--58--3Green Flag - No Issues
NOTE: As of today (May 25, 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