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 Neuralstem Inc. Phase 1 Stem Cell Clinical Trial NCT01772810:
Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI
Synopsis (excepted from ClinicalTrials.gov): This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury. The treatment will consist of laminectomy or laminoplasty of 1-4 vertebral segments overlying the region of spinal cord injury. The dura will be opened midline and direct injections into spinal parenchyma performed. 6 HSSC injections will be administered bilaterally.

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

Trial-Related Publications: n/a

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

1/18
2013
12/31
2013
NYR44-----First recordGreen Flag - No Issues
9/9
2013
12/31
2013
Rec44-----Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (6 months post-treatment)Yellow Flag - Minor Issue?
1/3
2014
2/28
2016
Rec44-----Primary completion date extended ex post facto. First extension of primary completion date, totalling 2+ yearsRed Flag - Serious Issue?
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