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Historical Analysis of Changes to Cytori Therapeutics Phase 1/2 Stem Cell Clinical Trial NCT02045888:
Safety and Feasibility of ADRCs (Adipose Derived Regenerative Cells) in Patients With Grade II Hamstring Tears (RECOVER)
Synopsis (excepted from ClinicalTrials.gov): A prospective, randomized, multi-center device trial intended to assess safety and feasibility, and inform dose selection in preparation for a pivotal trial. Subjects that have Grade II tears of the hamstring will be evaluated for eligibility in this study. Part A of the trial will be an open-label, safety, feasibility and dose-escalation study to assess whether the treatment approach (liposuction, cell processing and injection) is feasible in athletic patients at one or both doses of ADRCs. Part B of the trial is contingent on successful completion of Part A and is a multicenter, randomized, double blind trial of both doses of ADRCs vs. placebo.

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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1/23
2014
12/31
2015
Rec211----First recordGreen Flag - No Issues
NOTE: As of today (Mar 24, 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