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 2 Stem Cell Clinical Trial NCT01730716:
Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis
Synopsis (excepted from ClinicalTrials.gov): The study is to determine the feasibility, safety, toxicity, and maximum tolerated (safe) dose of human spinal derived neural stem cell transplantation for the treatment of Amyotrophic Lateral Sclerosis (ALS). 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.

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

11/20
2012
n/aNYR-------First recordGreen Flag - No Issues
1/11
2013
n/aNYR-------Immaterial changesGreen Flag - No Issues
5/6
2013
n/aNYR-------Immaterial changesGreen Flag - No Issues
5/7
2013
2/28
2014
ANR2--2---Extensive protocol changesGreen Flag - No Issues
5/9
2013
2/28
2014
ANR2--2---Immaterial changesGreen Flag - No Issues
5/14
2013
2/28
2014
ANR2--2---Immaterial changesGreen Flag - No Issues
6/4
2013
2/28
2014
Rec2--2---Green Flag - No Issues
12/4
2013
2/28
2014
Rec3-3----Anticipated primary completion date (Feb 2014) is unfeasible given current status (recruiting) and primary endpoint time frame (24 months post-treatment)Yellow Flag - Minor Issue?
1/6
2014
2/28
2014
Rec3-3----Immaterial changes. Anticipated primary completion date (Feb 2014) is unfeasible given current status (recruiting) and primary endpoint time frame (24 months post-treatment)Yellow Flag - Minor 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