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Historical Analysis of Changes to Cytomedix Phase 2 Stem Cell Clinical Trial NCT00654433:
ALD-101 Adjuvant Therapy of Unrelated Umbilical Cord Blood Transfusion (UCBT) in Patients With Inherited Metabolic Diseases (UCBT-002)
Synopsis (excepted from ClinicalTrials.gov): Eligible research subjects will receive an unrelated umbilical cord blood transfusion as a possible cure for their inherited metabolic disease. Subjects will be hospitalized and undergo high doses of chemotherapy which will destroy the child's normal cells including their bone marrow (which forms blood cells) in order to prepare their body for the umbilical cord blood transplant. The cord blood transplant is intended to rescue the child's bone marrow from the bad effects of the procedure. A portion of cord blood cells (ALD-101) will be separated from the cord blood unit and given approximately 4 hours after the standard cord blood transfusion. The study will test if the supplemental cells will increase the speed at which normal levels of circulating blood cells are re-established after transplant.

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

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
BACK TO INDEX

4/7
2008
11/30
2009
Rec1-1----First recordGreen Flag - No Issues
7/22
2008
11/30
2009
Rec2-2----Green Flag - No Issues
12/10
2008
11/30
2009
Rec3-3----Green Flag - No Issues
1/25
2009
11/30
2009
Rec3-3----Immaterial changesGreen Flag - No Issues
5/13
2009
11/30
2009
Rec3-3----Immaterial changesGreen Flag - No Issues
8/27
2009
11/30
2009
Rec3-3----Immaterial changesGreen Flag - No Issues
9/9
2009
11/30
2009
Rec3-3----Immaterial changesGreen Flag - No Issues
9/11
2009
11/30
2009
Rec3-3----Immaterial changesGreen Flag - No Issues
11/20
2009
7/31
2011
Rec3-3----Green Flag - No Issues
1/7
2010
7/31
2011
Sus3-3----Enrollment suspendedRed Flag - Serious Issue?
1/10
2011
7/31
2011
Sus3-3----No updates in 1+ yearsRed Flag - Serious Issue?
9/17
2013
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
9/18
2013
BREAKING
(News not yet reflected in trial‘s official record)
Cytomedix shutters stem cell programs [press release]
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