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Historical Analysis of Changes to Osiris Therapeutics Phase 3 Stem Cell Clinical Trial NCT00482092:
Evaluation of PROCHYMAL Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
Synopsis (excepted from ClinicalTrials.gov): Osiris Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and at least one biologic agent. The protocol investigates the safety and efficacy of using PROCHYMAL[tm] adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time. A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment. PROCHYMAL[tm] adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching.

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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6/1
2007
n/aRec1-1----First recordGreen Flag - No Issues
6/5
2007
n/aRec11-----Green Flag - No Issues
7/24
2007
n/aRec4-4----Green Flag - No Issues
8/8
2007
n/aRec6-6----Green Flag - No Issues
8/28
2007
n/aRec8-8----Enrollment goal increased from 258 to 270Green Flag - No Issues
8/29
2007
n/aRec10-10----Green Flag - No Issues
9/11
2007
n/aRec13-13----Green Flag - No Issues
10/12
2007
n/aRec17-17----Green Flag - No Issues
10/31
2007
n/aRec18-18----Green Flag - No Issues
11/19
2007
n/aRec24-24----Green Flag - No Issues
12/11
2007
n/aRec26-26----Green Flag - No Issues
1/10
2008
12/31
2008
Rec32-32----Green Flag - No Issues
1/17
2008
12/31
2008
Rec37-37----Green Flag - No Issues
1/31
2008
12/31
2008
Rec38-38----Green Flag - No Issues
2/13
2008
12/31
2008
Rec44-44----Green Flag - No Issues
2/19
2008
12/31
2008
Rec46-46----Green Flag - No Issues
2/29
2008
12/31
2008
Rec48-48----Green Flag - No Issues
3/19
2008
12/31
2008
Rec51-51----Green Flag - No Issues
4/16
2008
12/31
2008
Rec54-54----Green Flag - No Issues
6/23
2008
12/31
2008
Rec56-56----Green Flag - No Issues
8/12
2008
12/31
2008
Rec58-58----Green Flag - No Issues
9/2
2008
12/31
2008
Rec59-59----Green Flag - No Issues
9/21
2008
12/31
2008
Rec60-60----Green Flag - No Issues
11/10
2008
12/31
2008
Rec60-59---1One site suspendedYellow Flag - Minor Issue?
12/30
2008
12/31
2008
Rec60-56--13Multiple sites withdrawn, terminated, or suspendedRed Flag - Serious Issue?
2/3
2009
12/31
2008
Rec60-55--23Primary completion date exceeded. One site terminatedRed Flag - Serious Issue?
3/28
2009
6/30
2009
ANR60-55--23Recruitment suspended (see Mar 27 2009 press release)Red Flag - Serious Issue?
7/26
2010
12/31
2011
ANR60-55--23Primary completion date extended 2+ years. No updates in 1+ yearsRed Flag - Serious Issue?
9/27
2010
12/31
2011
Rec6014135-28Multiple sites withdrawn, terminated, or suspended. See May 5 2010 press releaseRed Flag - Serious Issue?
11/3
2010
12/31
2011
Rec6087231417Green Flag - No Issues
2/2
2011
12/31
2011
Rec60213171918One site withdrawnRed Flag - Serious Issue?
1/10
2012
12/31
2012
Rec60213171918Primary completion date extended ex post facto. Third extension of primary completion date, in aggregate totaling 3+ yearsRed Flag - Serious Issue?
1/11
2012
12/31
2012
Rec61-1653019Minor protocol changes. One site withdrawnRed Flag - Serious Issue?
2/13
2012
12/31
2012
Rec64-1953019Green Flag - No Issues
5/15
2012
12/31
2012
Rec65-2013419Green Flag - No Issues
11/2
2012
12/31
2012
Rec65-1913519Green Flag - No Issues
11/21
2012
12/31
2012
Rec65-1813619Green Flag - No Issues
1/28
2013
12/31
2013
Rec65-1813619Primary completion date extended ex post facto. Fourth extension of primary completion date, in aggregate totaling 4+ yearsRed Flag - Serious Issue?
4/30
2013
12/31
2013
Rec65-1713719Minor protocol changesGreen Flag - No Issues
5/15
2013
12/31
2013
Rec65-17-3819Green Flag - No Issues
10/28
2013
12/31
2013
Rec65-17-3819Immaterial changesGreen Flag - No Issues
1/15
2014
1/31
2014
Rec65-17-3819Green Flag - No Issues
NOTE: As of today (Aug 20, 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?

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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