4.4. Primary and Secondary end Points
chronic LBP
SECONDARY, DISC DEGENERATION
The primary endpoints were the safety and tolerability of administering matrilin-3-primed ASC spheroids combined with HA to patients with chronic LBP. Comprehensive safety evaluations were performed, encompassing peripheral blood tests, vital sign measurements, physical and neurological assessments, and systemic monitoring. Any AEs and SAEs were diligently recorded throughout the treatment and subsequent follow-up phases. The secondary endpoints included changes in the VAS, ODI, as well as variations in disc degeneration from the baseline to 6 months post-treatment. Scheduled clinical assessments and laboratory tests were conducted at specific intervals: 1 week, 1 month, 3 months, and 6 months after treatment. To evaluate changes in the disc height and hydration, lumbar spine X-ray imaging and T2-weighted MRI scans were performed before the procedure and at the 1- and 6-month marks post-treatment.