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Historical Analysis of Changes to Fate Therapeutics Phase 1 Stem Cell Clinical Trial NCT01527838:
Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit
Synopsis (excepted from ClinicalTrials.gov): A prospective, open-label, single-arm trial of the safety of a single FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity conditioning regimen for hematologic malignancies.

Issues Summary:   Potential major issue(s) detected - see table below

Trial-Related Publications: n/a

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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2/6
2012
3/31
2013
Rec3-3----Green Flag - No Issues
12/12
2012
3/31
2013
ANR3-3----Anticipated enrollment increased from 24 to 40Green Flag - No Issues
1/8
2013
3/31
2013
ANR3-3----Immaterial changesGreen Flag - No Issues
5/10
2013
4/30
2013
Com3-3----Enrollment decreased from 40 to 10. Primary completion date changed from Anticipated to Actual. Enrollment changed from Anticipated to ActualYellow Flag - Minor Issue?
5/30
2013
8/31
2013
ANR3-3----Trial status changed from Completed to Active, Not Recruiting. Primary completion date changed from Actual to AnticipatedYellow Flag - Minor Issue?
10/7
2013
10/31
2013
Com3---3--Green Flag - No Issues
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?

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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