Issues Summary: Potential major issue(s) detected - see table below
- 06/04/2013: Pluristem to receive clinical-hold notice from the U.S. FDA (press release)
- 09/16/2013: FDA Lifts Clinical Hold of Pluristem's Phase II Intermittent Claudication Study (press release)
TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
BACK TO INDEX
|n/a||Rec||6||-||6||-||-||-||-||Start date extended to Oct 2012. Record error: No primary completion date specified|
|n/a||Rec||9||-||9||-||-||-||-||Record error: No primary completion date specified|
|Rec||18||-||18||-||-||-||-||Added significant new exclusion criteria|
|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.|
|* Status abbreviations:|
|NYR:||not yet recruiting||Sus:||suspended|
|ANR:||active, not recruiting||Unk:||unknown|
** 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.
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