4.1. Study Design
ADVERSE EVENTS
The study protocol received approval from the Institutional Review Boards and Ethical Committees at CHA Bundang Medical Center (approval number 2018-10-013-034, October 2018) and the Ministry of Food and Drug Safety of Republic of Korea (approval number 202100348, March 2021). The study rigorously followed the principles stated in the Declaration of Helsinki and adhered to the guidelines of good clinical practice (ISO 14155). This clinical trial was registered with the ClinicalTrials.gov database under the identifier: NCT05011474. All study participants gave their written informed consent. The study was designed as a single-arm, open-label, phase I clinical trial carried out at CHA Bundang Medical Center with a follow-up duration of 6 months. We used a range of metrics to assess treatment outcomes, including the VAS, ODI, and lumbar spine MRI. The assessment schedule for the study is provided in Our primary goals centered on evaluating the safety and tolerability of intradiscal administration of matrilin-3 primed ASC spheroids combined with HA. We determined this through physical and neurological examinations, recording of adverse events (AEs), and observing shifts in laboratory values. Regarding treatment results, we noted changes in patient-reported VAS and ODI scores, as well as MRI findings. Additionally, our study protocol included follow-up appointments post-treatment at intervals of 1 week, and then at 1, 3, and 6 months, ensuring thorough clinical, laboratory, and imaging assessments. Regarding sample size estimation, Phase 1 trials do not require formal calculations as needed in Phase 2 and 3 studies. Given that standard Phase 1 clinical trials commonly include 6–10 participants, we determined that enrolling 8 subjects will sufficiently meet the objectives of our trial [