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Historical Analysis of Changes to Athersys, Inc. Phase 2 Stem Cell Clinical Trial NCT01240915:
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
Synopsis (excepted from ClinicalTrials.gov): MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.

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

Trial-Related Publications:

TIMELINE & ANALYSIS OF CHANGES TO THIS TRIAL'S RECORD
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11/12
2010
6/30
2012
NYR11-----First recordGreen Flag - No Issues
3/14
2011
7/31
2012
NYR33-----Green Flag - No Issues
3/22
2011
7/31
2012
Rec321----Green Flag - No Issues
4/8
2011
9/30
2012
Rec817----Minor protocol changesGreen Flag - No Issues
6/7
2011
9/30
2012
Rec11110----Green Flag - No Issues
12/22
2011
6/30
2012
Rec18117----Minor changes to primary and secondary outcome measures. Enrollment increased by 2 (to 128)Green Flag - No Issues
1/18
2012
6/30
2012
Rec18-18----Green Flag - No Issues
2/15
2012
6/30
2012
Rec24618----Green Flag - No Issues
3/20
2012
6/30
2012
Rec28918--1-Green Flag - No Issues
4/16
2012
1/31
2013
Rec311020--1-Green Flag - No Issues
5/18
2012
1/31
2013
Rec35925--1-Green Flag - No Issues
6/18
2012
4/30
2013
Rec381225--1-Green Flag - No Issues
7/19
2012
4/30
2013
Rec411327--1-Green Flag - No Issues
8/29
2012
7/31
2013
Rec5214343-1-Green Flag - No Issues
9/25
2012
7/31
2013
Rec5517343-1-Green Flag - No Issues
1/10
2013
7/31
2013
Rec6012443-1-Green Flag - No Issues
2/14
2013
7/31
2013
Rec6010463-1-Green Flag - No Issues
3/14
2013
7/31
2013
Rec607493-1-Green Flag - No Issues
4/15
2013
7/31
2013
Rec597483-1-Green Flag - No Issues
5/13
2013
10/31
2013
Rec618493-1-Sixth extension of primary completion date, in aggregate totaling 1+ yearsYellow Flag - Minor Issue?
6/13
2013
1/31
2014
Rec667543-2-Seventh extension of primary completion date, in aggregate totaling 1+ yearsYellow Flag - Minor Issue?
7/8
2013
1/31
2014
Rec54644121-Multiple sites deleted from trial recordYellow Flag - Minor Issue?
9/16
2013
1/31
2014
Rec54543-51-Green Flag - No Issues
10/15
2013
1/31
2014
Rec56542153-Green Flag - No Issues
11/18
2013
1/31
2014
Rec56543-53-Anticipated primary completion date (Jan 2014) may be unfeasible given current status (recruiting) and primary endpoint time frame (16 weeks post-treatment)Yellow Flag - Minor Issue?
12/16
2013
1/31
2014
Rec54242-55-Anticipated primary completion date (Jan 2014) is unfeasible given current status (recruiting) and primary endpoint time frame (16 weeks post-treatment). One site deletedYellow Flag - Minor Issue?
1/15
2014
1/31
2014
Rec542291166-Anticipated primary completion date (Jan 2014) is unfeasible given current status (recruiting) and primary endpoint time frame (16 weeks post-treatment). Five sites deletedYellow Flag - Minor Issue?
2/18
2014
4/30
2014
Rec52-221668-Anticipated primary completion date (Apr 2014) is unfeasible given current status (recruiting) and primary endpoint time frame (16 weeks post-treatment). Primary completion date extended ex post factoYellow Flag - Minor Issue?
3/3
2014
4/30
2014
ANR52-112768-Green Flag - No Issues
NOTE: As of today (Dec 11, 2018) this trial’s record has not been updated by the sponsor in 4+ 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