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 Pluristem Ltd. Phase 2 Stem Cell Clinical Trial NCT01679990:
Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication (IC)
Synopsis (excepted from ClinicalTrials.gov): The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in Intermittent Claudication subjects.

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

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
BACK TO INDEX

9/5
2012
n/aNYR-------First recordGreen Flag - No Issues
10/22
2012
n/aRec6-6----Start date extended to Oct 2012. Record error: No primary completion date specifiedYellow Flag - Minor Issue?
11/19
2012
n/aRec9-9----Record error: No primary completion date specifiedYellow Flag - Minor Issue?
11/29
2012
12/31
2015
Rec9-9----Green Flag - No Issues
1/14
2013
12/31
2015
Rec1239----Green Flag - No Issues
1/31
2013
12/31
2015
Rec14311----Green Flag - No Issues
3/6
2013
12/31
2015
Rec14212----Green Flag - No Issues
3/20
2013
12/31
2015
Rec16-16----Green Flag - No Issues
12/2
2013
12/31
2015
Rec17-17----Green Flag - No Issues
12/9
2013
12/31
2015
Rec18-18----Added significant new exclusion criteriaGreen Flag - No Issues
NOTE: As of today (Aug 20, 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?

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