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Historical Analysis of Changes to Aastrom Biosciences Phase 2 Stem Cell Clinical Trial NCT01670981:
An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM) (ixCELL DCM)
Synopsis (excepted from ClinicalTrials.gov): This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit. The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, all-cause hospital admissions, and unplanned outpatient or emergency department visits for intravenous administration of inotropic, vasoactive, or diuretic medications to treat acute worsening heart failure.

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

Trial-Related Publications: n/a

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

8/22
2012
8/31
2015
NYR1414-----First recordGreen Flag - No Issues
8/29
2012
8/31
2015
NYR1414-----Immaterial changesGreen Flag - No Issues
9/17
2012
8/31
2015
NYR1414-----Immaterial changesGreen Flag - No Issues
10/1
2012
8/31
2015
NYR1414-----Immaterial changesGreen Flag - No Issues
10/26
2012
8/31
2015
Rec14131----Green Flag - No Issues
12/3
2012
8/31
2015
Rec16142----Green Flag - No Issues
1/8
2013
8/31
2015
Rec17143----Green Flag - No Issues
1/22
2013
8/31
2015
Rec17125----Green Flag - No Issues
2/5
2013
8/31
2015
Rec17116----Green Flag - No Issues
2/20
2013
8/31
2015
Rec19136----Green Flag - No Issues
3/5
2013
8/31
2015
Rec22157----Green Flag - No Issues
3/12
2013
8/31
2015
Rec22148----Green Flag - No Issues
4/4
2013
8/31
2015
Rec24159----Green Flag - No Issues
4/10
2013
8/31
2015
Rec29209----Green Flag - No Issues
4/16
2013
8/31
2015
Rec301911----Green Flag - No Issues
5/9
2013
8/31
2015
Rec311912----Green Flag - No Issues
6/18
2013
8/31
2015
Rec311714----Green Flag - No Issues
7/18
2013
8/31
2015
Rec352114----Green Flag - No Issues
7/23
2013
8/31
2015
Rec352015----Green Flag - No Issues
7/24
2013
8/31
2015
Rec352015----Immaterial changesGreen Flag - No Issues
7/30
2013
8/31
2015
Rec351916----Green Flag - No Issues
8/13
2013
8/31
2015
Rec351817----Green Flag - No Issues
8/26
2013
8/31
2015
Rec351817----Significant liberalization of exclusion criteriaGreen Flag - No Issues
9/5
2013
8/31
2015
Rec351718----Green Flag - No Issues
10/30
2013
8/31
2015
Rec361224----Green Flag - No Issues
11/26
2013
8/31
2015
Rec361026----Green Flag - No Issues
1/21
2014
8/31
2015
Rec36828----Green Flag - No Issues
2/25
2014
8/31
2015
Rec38830----Minor protocol and inclusion/exclusion criteria changesGreen Flag - No Issues
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