THIS EXPERIMENTAL FEATURE IS CURRENTLY IN BETA
Information may change without notice  |  Send comments to trials(at)BusaConsultingLLC(dot)com
Historical Analysis of Changes to ThermoGenesis Corp. Phase 1/2 Stem Cell Clinical Trial NCT01472289:
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
Synopsis (excepted from ClinicalTrials.gov): The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients. A total of 15 patients suffering from end stage IV and V Rutherford /CLI in whom all previous therapeutic strategies failed (e.g. surgical revascularization) will be selected and undergo local transplantation of autologous BMMNCs. Cell therapies with mononuclear cells from patients own bone marrow is promising because these stem cells are capable of stimulating and regenerating capillaries and blood vessels (neovascularization).

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

Trial-Related Publications: n/a

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

11/15
2011
8/31
2012
Rec1-1----First record. Primary completion date (Aug 2012) may be unfeasible given current status (recruiting) and primary endpoint time frame (1 year)Yellow Flag - Minor Issue?
9/3
2013
9/3
2013
ANR1-1----Primary completion date extended ex post facto. First extension of primary completion date, totalling 1+ years. Primary completion date changed from Anticipated to ActualRed Flag - Serious Issue?
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?

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