None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : MIUChon is prepared in a 10cc syringe with 5mL of Normal Saline containing 4,700 MIUChon in the cell processing facility according to the administration schedule. It mu
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and 64 years 2. Patients with knee osteoarthritis who meet the clinical and radiological diagnostic criteria of the American College of Rheumatology (ACR) 3. Individuals classified as Kellgren-Lawrence grade 2–3 on X-ray 4. Patients experiencing osteoarthritis symptoms such as pain despite receiving conservative treatment 5. Patients who have voluntarily provided written consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1. Diseases of the spine or other lower limb joints that significantly affect the index knee 2. History of lower limb surgery within 6 months prior to screening or planned surgery during the study period 3. Any other joint symptoms that may affect the interpretation of clinical efficacy and/or safety data or make participation in this clinical study impossible 4. Corticosteroid injection in the index knee within 3 months prior to screening 5. Hyaluronic acid injection in the index knee within 6 months prior to screening 6. History of receiving cell or gene therapy 7. Screening test results showing any of the following: creatinine, bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) exceeding three times the upper limit of normal (ULN), or at least two of bilirubin, ALT, and AST exceeding twice the ULN 8. Participation in another clinical study within 4 weeks prior to screening 9. History of habitual use of psychoactive drugs or narcotic analgesics that may affect pain perception 10. Women of childbearing potential who do not agree to use effective contraception during the clinical study (effective contraception methods include sterilization, contraceptive pills, intrauterine devices, condoms, and spermicidal barrier methods) 11. Pregnant or breastfeeding women 12. History of malignancy diagnosed within 5 years prior to screening 13. Patients with clinically significant diseases such as hypertension, heart disease, or autoimmune diseases requiring ongoing treatment 14. Any other condition deemed inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AE) and serious adverse events (SAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in safety parameters, including vital signs, hematology, and clinical laboratory findings, including clinical chemistry;Changes from baseline in electrocardiogram (ECG);Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score;Visual Analogue Scale ;International Knee Documentation Committee;Short Form 36-Item Survey, Magnetic Resonance Imaging, X-ray | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Hyun Hwang
The Catholic University of Korea Catholic Medical Center
Outcome results
None listed