THIS EXPERIMENTAL FEATURE IS CURRENTLY IN BETA
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Historical Analysis of Changes to Osiris Therapeutics Phase 2 Stem Cell Clinical Trial NCT00877903:
Prochymal (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Synopsis (excepted from ClinicalTrials.gov): The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction. A therapy that could improve the myocardial remodeling process and reduce the incidence or severity of Congestive Heart Failure following acute myocardial infarction would provide a significant benefit. The characteristics and biologic activity of Prochymal®, along with a good safety profile in human trials to date, suggest that Prochymal® may be a good candidate for addressing this unmet medical need.

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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4/7
2009
3/31
2011
Rec1-1----First recordGreen Flag - No Issues
6/4
2009
3/31
2011
Rec1-1----Immaterial changesGreen Flag - No Issues
7/7
2009
3/31
2011
Rec11-11----Green Flag - No Issues
8/11
2009
3/31
2011
Rec18-18----Green Flag - No Issues
10/15
2009
3/31
2011
Rec26-26----Green Flag - No Issues
11/9
2009
3/31
2011
Rec41-41----Green Flag - No Issues
11/12
2009
3/31
2011
Rec41-41----Immaterial changesGreen Flag - No Issues
2/24
2010
3/31
2011
Rec41-41----Inclusion criteria significantly expanded (from LVEF 30-45% to 20-45%)Green Flag - No Issues
3/12
2010
3/31
2011
Rec37-37----Four trial sites deletedYellow Flag - Minor Issue?
4/5
2010
3/31
2011
Rec36-36----One trial site deletedYellow Flag - Minor Issue?
4/27
2010
3/31
2011
Rec34-34----Two trial sites deletedYellow Flag - Minor Issue?
6/8
2010
3/31
2011
Rec34-34----Last follow-up date extended 9 months. One trial site deletedYellow Flag - Minor Issue?
7/12
2010
3/31
2011
Rec33-33----One trial site deletedYellow Flag - Minor Issue?
8/24
2010
6/30
2011
Rec33-33----Last follow-up date extended 2 monthsGreen Flag - No Issues
3/9
2011
12/31
2011
ANR33-33----Projected enrollment changed from "Anticipated" to "Actual"Green Flag - No Issues
6/5
2012
12/31
2011
ANR33-33----Last follow-up date extended 36 months. Primary completion date changed from "anticipated" to "actual"Green Flag - No Issues
6/6
2012
12/31
2011
ANR33-33----Last follow-up date shortened by 36 monthsGreen Flag - No Issues
7/2
2012
Note: First publication of trial results (see Trial-Related Publications, above) implies that the trial reached its Primary Completion point, although the trial's status was not updated to 'Completed' (this is a common oversight)
Trial changes subsequent to the first results publication (other than a change of status to "Suspended" or "Terminated") are not flagged below
7/2
2012
12/31
2011
ANR33-33----Last follow-up date extended 36 months-

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