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Historical Analysis of Changes to Advanced Cell Technology Phase 1/2 Stem Cell Clinical Trial NCT01344993:
Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age Related Macular Degeneration (Dry AMD)
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 dry Age Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies of retinal pigment epithelium (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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11/10
2011
12/31
2013
Rec1-1----First recordGreen Flag - No Issues
11/10
2011
12/31
2013
Rec1-1----Immaterial changesGreen Flag - No Issues
1/17
2012
12/31
2013
Rec2-2----Green Flag - No Issues
1/20
2012
12/31
2013
Rec2-2----Immaterial changesGreen Flag - No Issues
1/31
2012
12/31
2013
Rec2-2----Immaterial changesGreen Flag - No Issues
4/2
2012
12/31
2013
Rec3-3----Inclusion criteria significantly broadened. Exclusion criteria significantly narrowedYellow Flag - Minor Issue?
5/17
2012
12/31
2013
Rec4-4----Green Flag - No Issues
9/7
2012
12/31
2013
Rec4-4----Immaterial changesGreen Flag - No Issues
1/30
2013
1/31
2014
Rec4-4----Significant liberalization of protocol (added a patient cohort with less advanced disease)Red Flag - Serious Issue?
2/1
2013
1/31
2014
Rec4-4----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 (Jan 21, 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