Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-175

Primary Outcome Measures :

1. Treatment Success (composite responder analysis of low back pain Visual Analogue Scale (VAS) score, Oswestry Disability Index (ODI) score and no post-treatment interventions) [ Time Frame: 24 Months ]
   • To determine Overall Treatment Success of rexlemestrocel-L alone or rexlemestrocel-L+HA through 24 months based on a composite responder analysis

Secondary Outcome Measures :

1. Effectiveness (Pain Responder analysis) [ Time Frame: 24 months ]
   • To evaluate the effectiveness of rexlemestrocel-L alone or rexlemestrocel-L+HA in reducing chronic low back pain by performing a Pain Responder analysis through 24 months post-treatment
2. Effectiveness (Functional Responder analysis) [ Time Frame: 24 months ]
   • To evaluate the effectiveness of rexlemestrocel-L alone or rexlemestrocel-L+HA in improving function by performing a Functional Responder analysis through 24 months post-treatment
3. Effectiveness (Treatment Success at 24 months) [ Time Frame: 24 months ]
   To determine the Treatment Success at 24 months of rexlemestrocel-L alone or rexlemestrocel-L+HA based upon a composite responder analysis
4. Effectiveness (Minimal Pain Responder at 24 months) [ Time Frame: 24 months ]
   Minimal Pain Responder at 24 Months: Measured as subjects meeting low back pain VAS score threshold
5. Effectiveness (Time to first intervention) [ Time Frame: 24 months ]
   To evaluate the effectiveness of rexlemestrocel-L alone or rexlemestrocel-L+HA on reducing the time to additional interventions at the treated level over 24 months post-treatment.