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Historical Analysis of Changes to Cytori Therapeutics Phase 1 Stem Cell Clinical Trial NCT00426868:
A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium
Synopsis (excepted from ClinicalTrials.gov): Subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility in this study. Eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRCs or placebo.

Issues Summary:   No issues detected

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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1/24
2007
2/28
2011
NYR11-----First recordGreen Flag - No Issues
1/26
2007
2/28
2011
NYR11-----Immaterial changesGreen Flag - No Issues
1/29
2007
2/28
2011
NYR11-----Immaterial changesGreen Flag - No Issues
1/30
2007
1/31
2011
Rec1-1----Green Flag - No Issues
7/30
2007
1/31
2011
Rec1-1----Immaterial changesGreen Flag - No Issues
8/2
2007
1/31
2011
Rec211----Green Flag - No Issues
2/4
2009
1/31
2011
Rec4-4----Green Flag - No Issues
2/5
2009
1/31
2011
Rec4-4----Immaterial changesGreen Flag - No Issues
6/27
2009
11/30
2009
ANR4-4----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
5/16
2011
11/30
2011
ANR4-4----Immaterial changes-
8/27
2013
3/1
2012
Com4-4----Actual enrollment significantly lower than anticipated (27 versus 36). Primary completion date changed from Anticipated to Actual.-

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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