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Historical Analysis of Changes to Cytomedix Phase 1 Stem Cell Clinical Trial NCT01003912:
Fetal Umbilical Cord Blood (UCB) Transplant for Lysosomal Storage Diseases (IUHST-001)
Synopsis (excepted from ClinicalTrials.gov): The purpose of this study is to determine the safety of first trimester fetal stem cell therapy using unrelated donor partially HLA-matched stem and progenitor cells derived from human umbilical cord blood for the treatment of selected lysosomal storage diseases that are known to cause severe and irreversible neurological disability in early infancy and which are lethal in childhood. A suitably matched unrelated umbilical cord blood will be identified and the 20% portion will be manipulated for the isolation of ALD-601 cells. ALD-601 (ALDHbr) cells are isolated by high speed flow sorting.

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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10/28
2009
12/31
2014
Rec2-2----First recordGreen Flag - No Issues
5/25
2010
12/31
2014
Rec2-2----Immaterial changesGreen Flag - No Issues
4/6
2011
12/31
2014
Rec2-2----Immaterial changesGreen Flag - No Issues
8/17
2011
12/31
2014
Rec2-2----Immaterial changesGreen Flag - No Issues
8/6
2012
12/31
2014
Rec2-2----Immaterial changesGreen Flag - No Issues
10/4
2012
12/31
2014
Rec2-2----Immaterial changesGreen Flag - No Issues
11/28
2012
12/31
2014
Rec2-2----Immaterial changesGreen Flag - No Issues
5/9
2013
12/31
2014
Rec2-2----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?
11/5
2013
12/31
2014
Rec2-2----Immaterial changesGreen 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