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Historical Analysis of Changes to Fate Therapeutics Phase 2 Stem Cell Clinical Trial NCT01627314:
Trial of a Single ProHema-CB Unit as Part of a Double CB Transplant in Patients With Hematologic Malignancies
Synopsis (excepted from ClinicalTrials.gov): An open-label randomized, prospectively and historically controlled trial of the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant following myeloablative conditioning for subjects age 15-55 years with 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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6/22
2012
9/30
2013
NYR55-----First recordGreen Flag - No Issues
1/8
2013
9/30
2013
Rec725----One site deleted from trial recordYellow Flag - Minor Issue?
5/10
2013
5/31
2013
Com725----Anticipated enrollment decreased from 45 to 10. Primary completion date changed from Anticipated to ActualYellow Flag - Minor Issue?
5/22
2013
8/31
2014
ANR725----Primary completion date extended ex post facto. Primary completion date changed from Actual to Anticipated.Yellow Flag - Minor Issue?
10/7
2013
5/31
2015
ANR8-8----Anticipated enrollment increased from 10 to 60Green Flag - No Issues
10/25
2013
5/31
2015
Rec8-8----Minor protocol change (from 45 treated / 15 control to 40 treated / 20 control)Green Flag - No Issues
NOTE: As of today (May 25, 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