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Historical Analysis of Changes to Advanced Cell Technology Phase 1/2 Stem Cell Clinical Trial NCT01469832:
Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients With Stargardt's Macular Dystrophy (SMD)
Synopsis (excepted from ClinicalTrials.gov): The purpose of this study is: (1) to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD; (2) to evaluate potential efficacy endpoints to be used in future studies of RPE cellular therapy.

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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11/9
2011
12/31
2013
Rec1-1----First recordGreen Flag - No Issues
1/30
2012
12/31
2013
Rec2-2----Green Flag - No Issues
1/31
2012
12/31
2013
Rec2-2----Immaterial changesGreen Flag - No Issues
7/27
2012
12/31
2013
Rec1-1----One site deleted from trial recordYellow Flag - Minor Issue?
8/22
2012
12/31
2013
Rec2-2----Green Flag - No Issues
1/30
2013
1/31
2014
Rec2-2----Significant liberalization of protocol (added a patient cohort with less advanced disease)Red Flag - Serious Issue?
2/1
2013
1/31
2014
Rec2-2----Immaterial changes. Anticipated primary completion date (Jan 2014) may be unfeasible given current status (recruiting) and primary endpoint time frame (1 year post-treatment)Red Flag - Serious Issue?
NOTE: As of today (Sep 20, 2019) this trial’s record has not been updated by the sponsor in 6+ 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