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Historical Analysis of Changes to Fate Therapeutics Phase 2 Stem Cell Clinical Trial NCT00890500:
Safety and Efficacy Study of a Single ProHema Modulated Umbilical Cord Blood Unit as Part of a Double Umbilical Cord Transplant in Subjects With Hematological Malignancies
Synopsis (excepted from ClinicalTrials.gov): ProHema modulated cord blood units are being tested to see if they can improve the ability of umbilical cord blood stem cells to grow after transplantation. After transplantation of two umbilical cord blood units, the average time to achieve engraftment is 25 days. In addition, up to 10% of patients who undergo umbilical cord blood transplantation never engraft, a potentially life-threatening condition. In laboratory studies, ProHEma modulated umbilical cord blood stem cells have been shown to enhance engraftment.

Issues Summary:   No issues detected

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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4/28
2009
12/31
2011
Rec211----First recordGreen Flag - No Issues
7/16
2009
12/31
2011
Rec211----Immaterial changesGreen Flag - No Issues
2/2
2010
12/31
2011
Rec211----Immaterial changesGreen Flag - No Issues
2/18
2011
12/31
2011
Rec2-2----Number of study arms reduced from 4 to 3Green Flag - No Issues
10/28
2011
12/31
2011
Rec2-2----Immaterial changesGreen Flag - No Issues
11/7
2011
8/31
2011
ANR2-2----Primary completion date changed from Anticipated to ActualGreen Flag - No Issues
12/13
2011
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
3/7
2013
3/31
2013
ANR2-2----Actual primary completion date changed ex post facto from 8/2011 to 3/2013-
5/30
2013
5/31
2015
ANR2-2----Phase 2 initiated. Number of study arms reduced from 3 to 2. Anticipated enrollment increased from 24 to 60-
10/7
2013
5/31
2013
Com2---2--Primary completion date changed from Anticipated to Actual. Phase changed from 2 to 1. Design changed from Randomized to Non-Randomized. Enrollment changed from Anticipated to Actual and from 60 to 12.-

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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