Recruitment Details 30 patients were included between 26/Jul/2012 (Pat. 01) and12/Dic/2012 (Pat. 30).
Pre-assignment Details All patients fulfilled the selection criteria, were randomized and received the assigned medication.
Efficacy evaluable patients (EEP): A patient has been considered evaluable whenever it has undergone the specified interventions (injection of hyaluronic acid or allogeneic MSC).
Safety population (SP): The population that includes all evaluable patients who have undergone one of the two study treatments.
The efficacy endpoint analysis will be based on all patients who have not committed major protocol violations, and have at least one assessment of efficacy of the end graft. 3 patients of the allogenic MSC treatment group were excluded from this analysis because of incomplete measurements.
MRI.Nº of values between 50-90 per visit.12.
Adverse Event Reporting Description All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.
The only disclosure restriction on the PI is that the sponsor must review results communications prior to public release.