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Historical Analysis of Changes to Cytomedix Phase 2 Stem Cell Clinical Trial NCT01774097:
Patients With Intermittent Claudication Injected With ALDH Bright Cells (PACE)
Synopsis (excepted from ClinicalTrials.gov): The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells taken from a patient's bone marrow can be placed safely, via intramuscular injections, into their affected calf and lower thigh muscles and improve blood flow and/or peak walking time in patients experiencing pain associated with blocked blood vessels in the leg.

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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1/18
2013
8/31
2014
NYR77-----First recordGreen Flag - No Issues
6/20
2013
11/30
2014
Rec7-7----Green Flag - No Issues
7/12
2013
11/30
2014
Rec7-7----Immaterial changesGreen Flag - No Issues
8/6
2013
11/30
2014
ANR7--7---Aldagen deleted as sponsorGreen Flag - No Issues
8/9
2013
11/30
2014
ANR7-7----Record changes of 8/6/2013 reversed.Green Flag - No Issues
8/13
2013
11/30
2014
Rec7-7----Record changes of 8/6/2013 reversed.Green Flag - No Issues
9/3
2013
11/30
2014
Rec7-7----Immaterial changesGreen Flag - No Issues
9/18
2013
BREAKING
(News not yet reflected in trial‘s official record)
Cytomedix shutters stem cell programs [press release]
Red Flag - Serious Issue?
12/2
2013
11/30
2014
Rec8-8----Red Flag - Serious Issue?
NOTE: As of today (Jan 21, 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?

BACK TO INDEX

* 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