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Historical Analysis of Changes to Cytomedix Phase 1 Stem Cell Clinical Trial NCT00314366:
Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br)
Synopsis (excepted from ClinicalTrials.gov): Recent studies have suggested that it may be possible to grow new blood vessels (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may stimulate the growth of new vessels. The day after a bone marrow harvest, the patient is taken to the cardiac catheterization lab where NOGA mapping is performed and the processed cells or placebo are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day.

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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4/12
2006
9/30
2008
Rec1-1----First recordGreen Flag - No Issues
4/15
2006
9/30
2008
Rec1-1----Immaterial changesGreen Flag - No Issues
9/25
2006
9/30
2008
Rec1-1----Immaterial changesGreen Flag - No Issues
2/4
2008
4/30
2010
Rec1-1----Significant extension of primary completion date. Minor protocol changes.Red Flag - Serious Issue?
6/29
2008
4/30
2010
ANR1-1----Green Flag - No Issues
3/31
2009
4/30
2010
ANR1-1----Significant reduction of target enrollment. Minor protocol changesRed Flag - Serious Issue?
11/18
2009
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
12/1
2009
4/30
2010
ANR1-1-----
7/6
2011
8/31
2009
ANR1--1---Primary Completion Date changed from "Anticipated" to "Actual"-
12/22
2011
8/31
2009
ANR1--1---Immaterial changes-
12/21
2012
8/31
2009
ANR1--1---Immaterial changes-
8/29
2013
8/31
2009
NYR1--1---Immaterial changes-
9/18
2013
BREAKING
(News not yet reflected in trial‘s official record)
Cytomedix shutters stem cell programs [press release]
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