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Historical Analysis of Changes to StemCells, Inc. Phase 1/2 Stem Cell Clinical Trial NCT01632527:
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration (AMD)
Synopsis (excepted from ClinicalTrials.gov): The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to age-related macular degeneration. HuCNS-SC cells will be transplanted by a board-certified vitreoretinal surgeon. The transplantation will be conducted in the eye with the inferior best-corrected visual acuity. The HuCNS-SC cells will be administered into the subretinal space through a standard surgical approach. Immunosuppressive agents will be administered orally to all subjects for a period of three months after surgery.

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

Trial-Related Publications: n/a

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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7/2
2012
12/31
2013
Rec1-1----First recordGreen Flag - No Issues
9/19
2012
12/31
2013
Rec1-1----Immaterial changesGreen Flag - No Issues
12/19
2012
12/31
2013
Rec1-1----Immaterial changesGreen Flag - No Issues
1/18
2013
12/31
2013
Rec1-1----Immaterial changes. Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
4/23
2013
12/31
2013
Rec2-2----Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
5/15
2013
12/31
2013
Rec2-2----Immaterial changes. Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
10/15
2013
4/30
2014
Rec2-2----Inclusion criteria changed from 20/200 worst vision to 20/320. Anticipated primary completion date extended 4 months to Apr 2014.Green Flag - No Issues
11/8
2013
4/30
2014
Rec3-3----Anticipated primary completion date (Apr 2014) unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
1/21
2014
4/30
2014
Rec3-3----Anticipated primary completion date (Apr 2014) is unfeasible given current status (recruiting) and primary endpoint time frame (1 year post-treatment). Immaterial changesYellow Flag - Minor Issue?
NOTE: As of today (Mar 24, 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