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Historical Analysis of Changes to Cytori Therapeutics Phase 1 Stem Cell Clinical Trial NCT00442806:
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
Synopsis (excepted from ClinicalTrials.gov): The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction. Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate.

Issues Summary:   No issues detected

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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3/1
2007
6/30
2011
NYR11-----First recordGreen Flag - No Issues
8/2
2007
6/30
2011
NYR22-----Green Flag - No Issues
11/9
2007
6/30
2011
Rec211----Green Flag - No Issues
2/5
2008
6/30
2011
Rec2-2----Green Flag - No Issues
6/27
2009
11/30
2009
ANR2-2----Green Flag - No Issues
5/7
2010
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
3/31
2011
11/30
2009
ANR2-2----Anticipated primary completion date exceeded by 1+ years. Immaterial changes.-
5/16
2011
11/30
2011
ANR2-2----Significant extension of primary completion date (1+ years)-
11/25
2013
4/30
2012
Com2---2--Primary completion date changed from "anticipated" to "actual." Last follow-up date changed from "anticipated" to "actual." Enrollment changed from "anticipated" (48) to "actual" (14).-

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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