None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : This clinical study is conducted as a randomized, double-blind, placebo-controlled, parallel-group design. A total of 30 patients with knee osteoarthritis are allocated
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 20 years or older 2. Patients with knee osteoarthritis meeting the clinical and radiographic diagnostic criteria of the American College of Rheumatology (ACR) 3. Kellgren-Lawrence grade 2–3 on X-ray. However, patients diagnosed with knee osteoarthritis may be enrolled even without knee X-ray results performed at this institution. 4. Pain intensity of 70 mm or greater on the 100 mm Visual Analogue Scale (VAS) of the index knee at screening 5. WOMAC function score of 34 or greater in the index knee at screening 6. Medial joint space width (JSW) of 1.5–4 mm in the index knee at screening 7. Patients with clinical symptoms of osteoarthritis such as pain despite conservative treatment 8. Patients who voluntarily provide written informed consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1. BMI > 35 kg/m² 2. Spinal or other lower extremity joint disease significant enough to affect the index knee 3. Lower extremity surgery (e.g., hip, knee) within 6 months prior to screening, or surgery planned during the study period 4. Any other joint condition that may affect the interpretation of clinical efficacy and/or safety data or preclude participation in this study (i.e., currently symptomatic fractures or concomitant rheumatic diseases including, but not limited to, fibromyalgia, rheumatoid arthritis, and Reiter's syndrome) 5. Corticosteroid injection into the index knee within 3 months prior to screening 6. Hyaluronic acid injection into the index knee within 6 months prior to screening 7. Prior administration of cell therapy or gene therapy products 8. Creatinine, bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) exceeding 3.0 times the upper limit of normal (ULN) for any single parameter, or two or more of bilirubin, ALT, or AST exceeding 2.0 times the ULN at screening laboratory tests 9. Participation in another clinical study within 3 months prior to screening 10. Use of psychotropic drugs or narcotic analgesics (morphine, fentanyl, oxycodone, hydromorphone) that may affect pain perception (except for patients who have been stably taking codeine or tramadol without dose change for 4 or more weeks prior to screening, who are eligible for enrollment) 11. Women of childbearing potential who do not agree to use effective contraception during the study period (effective contraception: sterilization, oral contraceptives, intrauterine devices, condoms, barrier methods with spermicide) 12. Pregnant or breastfeeding women 13. Patients diagnosed with malignancy within 5 years prior to screening 14. Patients with clinically significant uncontrolled conditions requiring ongoing treatment, including hypertension, cardiac disease, autoimmune disease, or hepatic impairment, as judged by the investigator 15. Patients with infection or skin disease at the injection site 16. Patients with a history of hypersensitivity to the investigational medicinal product 17. Any other patients deemed ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs); changes from baseline in safety parameters including vital signs, electrocardiogram (EKG), hematology, and clinical chemistry laboratory findings;Assessment of immunogenicity: presence or absence of serum anti-HLA antibody formation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function score of the index knee at 12 months post-administration;Change from baseline in index knee pain Visual Analogue Scale (VAS) score at 12 months post-administration;Change from baseline in WOMAC function score at each visit timepoint;Change from baseline in pain VAS score at each visit timepoint;Change from baseline in KOOS (Knee Injury and Osteoarthritis Outcome Score) at each visit timepoint;Change from baseline in IKDC (International Knee Documentation Committee) score at each visit timepoint;Change from baseline in cartilage volume, cartilage defect size, and T1rho assessed by MRI;Change from baseline in Kellgren-Lawrence (K&L) grade and medial joint space width assessed by knee X-ray;Change from baseline in bone markers (CTX-I, uCTX-II, Osteocalcin, PINP) and blood inflammatory markers (IL-1ß, TNF-a, IL-6, TGF-ß1, ESR, CRP);Change from baseline in exploratory bone markers (PIIANP, PIIBNP, PIINP, COMP, CS846) and blood inflammatory markers;Change from baseline in synovial fluid PIIBNP and MMP-3 levels | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Hyun Hwang
The Catholic University of Korea Catholic Medical Center
Outcome results
None listed