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Historical Analysis of Changes to Cytori Therapeutics Phase 1/2 Stem Cell Clinical Trial NCT01556022:
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA)
Synopsis (excepted from ClinicalTrials.gov): To assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization. Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. Intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.

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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3/15
2012
7/31
2013
NYR22-----First recordGreen Flag - No Issues
5/24
2012
12/31
2013
NYR22-----Minor protocol changesGreen Flag - No Issues
8/9
2012
12/31
2013
Rec211----Green Flag - No Issues
3/12
2013
12/31
2013
Rec633----Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
4/30
2013
12/31
2013
Rec624----Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
6/5
2013
12/31
2013
Rec624----Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
6/12
2013
12/31
2013
Rec615----Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
8/27
2013
12/31
2013
Rec6-6----Anticipated primary completion date (Dec 2013) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
1/30
2014
5/31
2014
Rec8-8----Primary completion date extended ex post facto. Second extension of primary completion date, totalling 10 months. Anticipated primary completion date (May 2014) may be unfeasible given current status (recruiting) and primary endpoint time frame (one year)Yellow Flag - Minor Issue?
NOTE: As of today (May 25, 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