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Historical Analysis of Changes to Neuralstem Inc. Phase 1 Stem Cell Clinical Trial NCT01348451:
Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Synopsis (excepted from ClinicalTrials.gov): This is a first-in-human trial of spinal derived stem cells transplanted into the spinal cord of patients with Amyotrophic Lateral Sclerosis (ALS). The goal of the study is to see if the cells and the procedure to transplant them are safe. These stem cells are called Human Spinal Stem Cells (HSSC) and have been engineered from the spinal cord of a single fetus electively aborted after 8 weeks of gestation. The tissue was obtained with the mother's consent. The cells will be transplanted into the ALS patient's spinal cord after laminectomy, an operation that removes bone surrounding the spine. Because the HSSC are human in origin, their transplantation will be handled in some ways like other organ transplants in that patients will receive immunosuppressive medications to prevent the rejection of the cells.

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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5/4
2011
11/30
2011
ANR1--1---First record. Record error: trial status (active, not recruiting) is not valid for a first record.Yellow Flag - Minor Issue?
10/25
2011
4/30
2012
Rec1-1----Green Flag - No Issues
12/21
2011
4/30
2012
Rec1-1----Trial status changed to "enrolling by invitation"Green Flag - No Issues
5/7
2012
12/31
2012
Rec1-1----Green Flag - No Issues
6/14
2012
12/31
2012
ANR1-1----Green Flag - No Issues
11/7
2012
12/31
2012
ANR1-1----Immaterial changesGreen Flag - No Issues
1/11
2013
4/30
2013
ANR1-1----Extension of primary completion date appears inconsistent with trial status (active, not recruiting)Yellow Flag - Minor Issue?
5/9
2013
6/30
2013
ANR1-1----Primary completion date extended ex post facto. Fourth extension of primary completion date, in aggregate totalling 1+ yearsRed Flag - Serious Issue?
1/6
2014
6/30
2014
ANR1-1----Primary completion date extended ex post facto. Fifth extension of primary completion date, totalling 2+ yearsRed Flag - Serious Issue?
NOTE: As of today (Jan 22, 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