THIS EXPERIMENTAL FEATURE IS CURRENTLY IN BETA
Information may change without notice  |  Send comments to trials(at)BusaConsultingLLC(dot)com
Historical Analysis of Changes to Cytomedix Phase 2 Stem Cell Clinical Trial NCT01273337:
Study of ALD-401 Via Intracarotid Infusion in Ischemic Stroke Subjects
Synopsis (excepted from ClinicalTrials.gov): The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by intracarotid infusion and to assess efficacy of treatment in subjects who have had unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA). ALD-401 is made from the stroke patient's bone marrow. Bone marrow cells are processed, sorted and formulated into a 3 mL suspension of ALD-401. Two days after harvest, subjects in the ALD-401 group will have their processed bone marrow cells (ALD-401) injected via intracarotid/MCA infusion.

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

1/7
2011
5/31
2013
NYR-------First recordGreen Flag - No Issues
1/10
2011
5/31
2013
NYR-------Immaterial changesGreen Flag - No Issues
3/10
2011
5/31
2013
NYR11-----Green Flag - No Issues
3/17
2011
5/31
2013
Rec1-1----Green Flag - No Issues
6/3
2011
5/31
2013
Rec312----Green Flag - No Issues
7/11
2011
5/31
2013
Rec3-3----Green Flag - No Issues
9/22
2011
5/31
2013
Rec3-3----Minor protocol changesGreen Flag - No Issues
5/30
2012
5/31
2013
Rec4-4----Immaterial changesGreen Flag - No Issues
9/20
2012
5/31
2013
Rec8-8----Anticipated primary completion date (May 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (1 year post-treatment). Minor changes to inclusion criteria. Minor changes to exclusion criteriaYellow Flag - Minor Issue?
12/14
2012
5/31
2013
Rec10181---Anticipated primary completion date (May 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (1 year post-treatment). Minor changes to inclusion criteria. Minor changes to exclusion criteriaYellow Flag - Minor Issue?
7/29
2013
7/31
2014
Rec12291---Primary completion date extended ex post facto. First extension of primary completion date, totalling 1+ yearsRed Flag - Serious Issue?
9/18
2013
BREAKING
(News not yet reflected in trial‘s official record)
Cytomedix shutters stem cell programs [press release]
Red Flag - Serious Issue?
1/15
2014
7/31
2014
ANR14--9--5Green Flag - No Issues
NOTE: As of today (Dec 11, 2018) this trial’s record has not been updated by the sponsor in 4+ years. The trial’s current status is therefore questionable.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