THIS EXPERIMENTAL FEATURE IS CURRENTLY IN BETA
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Historical Analysis of Changes to NeoStem Phase 1 Stem Cell Clinical Trial NCT00313339:
Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction (AMR-1)
Synopsis (excepted from ClinicalTrials.gov): There is a great potential for stem cell therapy, using a variety of cell precursors (particularly hematopoietic) to contribute to new blood vessel formation (and possibly limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies. Therefore, we propose to evaluate the safety and efficacy of an autologous bone marrow derived CD34+ cell product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement.

Issues Summary:   No issues detected

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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4/11
2006
n/aRec1-1----First recordGreen Flag - No Issues
3/30
2009
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
1/28
2010
3/31
2009
ANR1-1----Primary completion date changed from "anticipated" to "actual." Numerous protocol changes-
4/9
2010
3/31
2009
ANR1-1-----
7/9
2012
3/31
2009
ANR1-1----Last follow-up date extended 1 year-
11/13
2012
3/31
2009
ANR1-1----Immaterial changes-
9/13
2013
3/31
2009
Com1-1----Last follow-up date (3/2013) changed from Anticipated to Actual. Enrollment changed from Anticipated (40) to Actual (31).-
11/15
2013
3/31
2009
Com1-1----Immaterial changes-

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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