(1) To be eligible for the Expanded Access Program, the patient must have a ① serious or life-threatening condition (e.g., Knee Osteoarthritis of K-L grade 3), ② a condition that does not have satisfactory alternative treatment options available, ③ and be unable to participate in ongoing clinical trials. This Expanded Access Program aims to provide a treatment opportunity with JointStem—an autologous adipose-derived mesenchymal stem cell product (1×10^8 cells/3 mL)—to patients with K-L grade 3 knee osteoarthritis whose symptoms have persisted for more than 3 months despite SOC treatment.
(2) This Expanded Access Program is intended for patients with osteoarthritis of the knee to assess the symptom-relieving effect of JointStem. Only patients who have received sufficient explanation of the program and voluntarily signed the informed consent form will be evaluated for patient eligibility during the screening phase. If eligible, they will undergo fat tissue and blood collection. Once the JointStem product is manufactured, patients will visit the site to receive a single dose of JointStem and will undergo regular follow-up evaluations for safety and efficacy over 24 weeks.