PLX-PAD has demonstrated a favorable safety profile and regenerative potential across multiple clinical trials. In a global Phase III study evaluating PLX-PAD in muscle recovery following hip fracture surgery (n=240), patients treated with PLX-PAD showed a statistically significant increase in Hip Abduction Strength (HAS) at both 26 and 52 weeks compared to placebo. These findings reinforce earlier Phase I/II data, which demonstrated that intramuscular injection of PLX-PAD led to marked improvements in muscle force in both the operated and contralateral legs. Notably, the Phase I/II trial showed a ~40-fold greater improvement in the non-operated leg with 150M cells vs. placebo (p=0.0114), and a 5.8-fold greater force improvement in the operated leg (p=0.0067), with an excellent safety profile at 12 months.
Together, these results suggest PLX-PAD may exert both localized and systemic therapeutic effects on muscle regeneration, supporting its continued development for orthopedic indications and broader musculoskeletal applications.