None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Injection of CATHOLIC MASTER cells 1 x 108cells/2cc / saline 2cc (placebo) into knee of patents with osteoarthritis
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 20-80 2. diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for knee OA 3. symptomatic OA that lastede for at least 3 months before screening 4. Baseline Pain VAS =50 mm 5. treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due to OA pain 6. X-ray Kellgren-Lawrence grade 1~4 7. volauntarily enrolled with informed consent 8. no improvement with medical treatment for at least 3months
Exclusion criteria
Exclusion criteria: 1. disease in spine or lower extremities that can affect the outcome of index knee 2. surgery on lower extremities within 6month before injection or planned 3. joint symptoms that can affect the interpretation of the trial data or prevent the subject from enrollement including but not limited to symptomatic fracture, fibromyalgia, rheumatoid arthritis, reactive arthritis 4. steroid injection to the index knee within preivious 3months 5. hyaluronic acid injection to the index knee within preivious 6months 6. underwent cell therapy or gene therapy in the past 7. more than 3 times upper normal limit in one or more of the followings: serum creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or more than 3 times upper normal limit in two or more of the followings: bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 8. participation in a different clinical trial other than this within 4 weeks after initiation of the current study 9. use (reccuent use or addiction) of substances that can affect pain sensation such as narcotics 10. females of childbearing age who do not consent to effective contraceptive methods during the study period 11. pregnant or lactating woman 12. malignancy 13. considered to be inappropriate for the trial by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event according to CTCAE 5.0, clinically meaningful abnormalites in laboratory tests (blood/urine) | — |
Secondary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) score;Knee injury and Osteoarthritis Outcome Score (KOOS);international knee documentation committee (IKDC);knee MRI;SF -36 questionnaire;serum inflammatory cytokine, acute phase reactant, bone turnover marker;knee x-ray | — |
Countries
Korea, Republic of
Contacts
Public ContactJooha Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed