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Historical Analysis of Changes to Advanced Cell Technology Phase 1/2 Stem Cell Clinical Trial NCT01345006:
Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macular Dystrophy
Synopsis (excepted from ClinicalTrials.gov): A safety and tolerability trial to evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with Stargardt's Macular Dystrophy (SMD).

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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4/28
2011
7/31
2013
Rec1-1----First recordGreen Flag - No Issues
5/16
2011
7/31
2013
Rec2-2----Green Flag - No Issues
11/7
2011
7/31
2013
Rec1-1----One site deleted from trial recordYellow Flag - Minor Issue?
2/14
2012
7/31
2013
Rec2-2----Green Flag - No Issues
7/12
2012
7/31
2013
Rec3-3----Green Flag - No Issues
1/30
2013
7/31
2013
Rec3-3----Significant liberalization of protocol (added a patient cohort with less advanced disease). Anticipated primary completion date (Jul 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (1 year)Red Flag - Serious Issue?
2/1
2013
7/31
2013
Rec3-3----Immaterial changes. Anticipated primary completion date (Jul 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (1 year post-treatment)Red Flag - Serious Issue?
NOTE: As of today (Dec 12, 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