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Historical Analysis of Changes to Cytori Therapeutics Phase 2 Stem Cell Clinical Trial NCT01216995:
Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (ADVANCE)
Synopsis (excepted from ClinicalTrials.gov): Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI). This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites.

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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10/7
2010
12/31
2012
NYR11-----First recordGreen Flag - No Issues
3/31
2011
12/31
2012
NYR11-----Immaterial changesGreen Flag - No Issues
5/16
2011
6/30
2014
Rec1-1----Significant extension of primary completion date (1+ years)Yellow Flag - Minor Issue?
7/11
2012
9/30
2015
NYR1-1----Number of arms reduced from 3 to 2. Significant reduction of target enrollment (from 360 to 216). Significant extension of primary completion date (1+ years). Record error: trial status changed from "recruiting" to "not yet recruiting." Minor changes to inclusion and exclusion criteriaRed Flag - Serious Issue?
10/23
2012
9/30
2015
Rec431----Green Flag - No Issues
11/20
2012
9/30
2015
Rec413----Rate of new sites entering trial may be insufficient to achieve the anticipated primary completion date.Red Flag - Serious Issue?
8/8
2013
Note: First publication of trial results (see Trial-Related Publications, above) implies that the trial reached its Primary Completion point, although the trial's status was not updated to 'Completed' (this is a common oversight)
Trial changes subsequent to the first results publication (other than a change of status to "Suspended" or "Terminated") are not flagged below
8/12
2013
BREAKING
(News not yet reflected in trial‘s official record)
Cytori announces ADVANCE trial to be terminated [Source]
Red Flag - Serious Issue?
10/5
2013
5/31
2015
ANR4--31--Enrollment changed from Anticipated to Actual and reduced from 216 to 23-
11/25
2013
5/31
2015
ANR4--31--Immaterial changes-

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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