A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intra-Articular Allocetra in Patients with Primary Knee Osteoarthritis

Condition studied

Knee Osteoarthritis

Investigational medicinal product(s)

Eligibility

Primary endpoint

The change from baseline of the WOMAC Pain score at 3 months between Allocetra and Placebo., The change from baseline for the WOMAC Function score at 3 months., Incidence and severity of Adverse Events (AEs), treatment disruptions/ discontinuations and evaluation of safety laboratory values up to 6 months.

Endpoint detail

The change from baseline of the WOMAC Pain score at 6 months., The change from baseline of the WOMAC Function score at 6 months., The change from baseline for the WOMAC Total score at 3 months., The change from baseline of the WOMAC Total score at 6 months., The change from baseline of the Average Daily Pain Numerical Rating Scale (ADP-NRS) at 3 months., The change from baseline of the ADP-NRS at 6 months.