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Historical Analysis of Changes to Osiris Therapeutics Phase 2 Stem Cell Clinical Trial NCT00690066:
PROCHYMAL (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
Synopsis (excepted from ClinicalTrials.gov): The purpose of this study is to establish the safety and efficacy of multiple administrations of PROCHYMAL® in subjects recently diagnosed with type 1 diabetes mellitus, an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Insulin is the primary method of controlling diabetes by regulating blood glucose levels, but it may not reverse or prevent disease progression. The active ingredient in ROCHYMAL® is adult human mesenchymal stem cells (MSCs). MSCs have been shown to interact with the immune cells in the body, reducing inflammation and assisting in tissue repair. This study will help determine whether MSCs can protect normal pancreatic tissue from autoimmune attack and repair damaged pancreatic tissue, leading to an increase in insulin production and decrease in circulating blood glucose.

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

Trial-Related Publications:

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

6/3
2008
6/30
2010
Rec1-1----First recordGreen Flag - No Issues
7/7
2008
6/30
2010
Rec2-2----Green Flag - No Issues
10/1
2008
6/30
2010
Rec4-4----Green Flag - No Issues
10/21
2008
6/30
2010
Rec8-8----Green Flag - No Issues
12/31
2008
6/30
2010
Rec17512----Green Flag - No Issues
2/4
2009
6/30
2010
Rec17512----Immaterial changesGreen Flag - No Issues
2/18
2009
6/30
2010
Rec17215----Green Flag - No Issues
2/19
2009
6/30
2010
Rec17215----Immaterial changesGreen Flag - No Issues
3/1
2009
6/30
2010
Rec17215----Immaterial changesGreen Flag - No Issues
3/23
2009
6/30
2010
Rec20416----Green Flag - No Issues
4/14
2009
6/30
2010
Rec20317----Green Flag - No Issues
5/9
2009
6/30
2010
Rec20317----Immaterial changesGreen Flag - No Issues
6/22
2009
6/30
2010
Rec20-20----Green Flag - No Issues
9/8
2009
6/30
2010
Rec20-20----Inclusion criteria significantly expandedRed Flag - Serious Issue?
9/14
2009
6/30
2010
Rec20-20----Immaterial changesGreen Flag - No Issues
11/12
2009
6/30
2010
Rec20-20----Immaterial changesGreen Flag - No Issues
1/15
2010
12/31
2010
ANR20-20----Trial status change to "active, not recruiting" may be inconsistent with extension of primary completion dateRed Flag - Serious Issue?
8/30
2010
12/31
2010
ANR20-20----Immaterial changesGreen Flag - No Issues
9/10
2010
12/31
2010
ANR20-20----Immaterial changesGreen Flag - No Issues
2/7
2011
12/31
2010
ANR20-20----Immaterial changes. Primary completion date exceededYellow Flag - Minor 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