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Historical Analysis of Changes to BrainStorm Cell Therapeutics Phase 1/2 Stem Cell Clinical Trial NCT01051882:
Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients
Synopsis (excepted from ClinicalTrials.gov): The study will evaluate the safety, tolerability and therapeutic effects of injection of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), as a possible treatment for patients with Amyotrophic Lateral Sclerosis (ALS) at the early and progressive disease stages. Patients will undergo a Bone Marrow Aspiration procedure and MSC-NTF cells will be produced from the bone marrow aspirate based on Brainstorm Cell Therapeutics Ltd proprietary method. MSC-NTF will be transplanted by IM or IT injection to the early and progressive ALS patients respectively.

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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1/19
2010
9/30
2011
NYR11-----First recordGreen Flag - No Issues
6/2
2010
2/28
2012
NYR11-----Extensive protocol changesGreen Flag - No Issues
6/16
2010
12/31
2012
NYR11-----Second extension of primary completion date, in aggregate totaling 1+ years.Yellow Flag - Minor Issue?
4/27
2011
12/31
2012
NYR11-----Recruitment not yet initiated 1+ year after registration. Minor protocol changesYellow Flag - Minor Issue?
6/14
2011
12/31
2012
ANR11-----Trial status change from "not yet recruiting" to "active, not recruiting" with no sites yet recruiting is implausibleYellow Flag - Minor Issue?
6/22
2011
12/31
2012
Rec1-1----Minor changes to inclusion criteriaGreen Flag - No Issues
8/6
2012
12/31
2012
ANR1-1----No updates in 1+ years.Red Flag - Serious Issue?
3/21
2013
Note: First publication of trial results (see Trial-Related Publications, above)
Trial changes subsequent to the first results publication (other than a change of status to "Suspended" or "Terminated") are not flagged below
7/2
2013
12/31
2012
Com1-1----Trial completed. Last follow-up date was March 2013. Actual enrollment (12) significantly less than anticipated enrollment (24). Record error: trial status "completed" but site status "recruiting"-
11/6
2013
12/31
2012
Com1---1---

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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