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Historical Analysis of Changes to Pluristem Ltd. Phase 1/2 Stem Cell Clinical Trial NCT01525667:
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Synopsis (excepted from ClinicalTrials.gov): Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA). One of the main problems when performing THA via the standard transgluteal approach is the necessary injury of the gluteus medius muscle. The consecutive decrease of contractile muscle substance and the substitution by scar tissue leads to functional deficits of the pelvic-stabilizing musculature with an insufficiency limp in a large number of patients. The present study has the aim of establishing a new therapy for iatrogenic gluteal muscle damage. The hypothesis of the present proposal is that intra-muscular (IM) injection of PLX-PAD into the iatrogenically injured gluteus medius muscle after THA results in an improved regeneration of the skeletal muscle tissue and consecutively in an improved functional outcome.

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

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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2/2
2012
12/31
2013
NYR11-----First recordGreen Flag - No Issues
5/7
2012
n/aNYR11-----Start date extended to Jul 2012Green Flag - No Issues
6/18
2012
n/aNYR11-----Start date extended to Sep 2012Green Flag - No Issues
8/27
2012
n/aNYR11-----Start date extended to Nov 2012Green Flag - No Issues
11/15
2012
3/31
2014
Rec1-1----Green Flag - No Issues
3/20
2013
3/31
2014
Rec1-1----Significant protocol changesGreen Flag - No Issues
4/18
2013
3/31
2014
Rec1-1----Significant protocol changes. Anticipated primary completion date (Mar 2014) may be unfeasible given current status (recruiting) and primary endpoint time frame (104 weeks)Yellow Flag - Minor Issue?
8/27
2013
3/31
2014
ANR1-1----Anticipated primary completion date (Mar 2014) may be unfeasible given current status (recruiting) and primary endpoint time frame (104 weeks)Yellow Flag - Minor 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