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Historical Analysis of Changes to StemCells, Inc. Phase 1/2 Stem Cell Clinical Trial NCT01321333:
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
Synopsis (excepted from ClinicalTrials.gov): This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury. Study subjects will receive immunosuppression for nine months following transplantation.

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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3/22
2011
12/31
2015
Rec1-1----First recordGreen Flag - No Issues
11/3
2011
12/31
2015
Rec1-1----Immaterial changesGreen Flag - No Issues
5/23
2012
12/31
2015
Rec1-1----Immaterial changesGreen Flag - No Issues
5/24
2012
12/31
2015
Rec1-1----Immaterial changesGreen Flag - No Issues
9/19
2012
12/31
2015
Rec1-1----Immaterial changesGreen Flag - No Issues
1/18
2013
12/31
2015
Rec1-1----Immaterial changesGreen Flag - No Issues
4/23
2013
12/31
2015
Rec1-1----Immaterial changesGreen Flag - No Issues
10/15
2013
12/31
2015
Rec1-1----Immaterial changesGreen Flag - No Issues
12/13
2013
12/31
2015
Rec3-21---Green Flag - No Issues
1/15
2014
12/31
2015
Rec3-21---Immaterial changesGreen Flag - No Issues
1/21
2014
12/31
2015
Rec3-21---Immaterial changesGreen Flag - No Issues
NOTE: As of today (Oct 16, 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