Osteoarthritis of the Knee Osteoarthritis, Knee
Conditions
Interventions
A single dose of either a mixture of 1.5 mL of saline and 1.5 mL of PSO17J or 3.0 mL of PSO17J is administered into the knee joint cavity.
D007719
knee joint
Sponsors
Onodera Tomohiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy adult males between the ages of 18 and under 60 at the time of consent (2)No symptoms of knee joint pain within 4 weeks prior to enrollment (3)Subjects with no previous trauma to the knee joint. (4)Subjects who do not have grade 2 or higher Kellgren-Lawrence classification knee osteoarthritis of the tibiofemoral joint on radiographs. (5) Subjects who have been fully informed of the details of this clinical trial and have given their written consent.
Exclusion criteria
Exclusion criteria: (1) Subjects who have medical devices implanted or placed that contain metal (except for medical devices that have been conditionally approved as compatible with the MRI system), have tattoos (including art makeup), or are unable to undergo MRI examination due to claustrophobia, etc. (2)Subjects whose lesions are detected in the MRI scan at screening and who are judged by the investigator or subinvestigator to have problems participating in the study. (3)Subjects who have undergone surgical treatment of the cartilage of knee joint in the subject area (4)Obese with a BMI of 30 or more (5)Subjects with complications or history of the following diseases Autoimmune diseases such as gout, pseudogout, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, autoimmune thyroid disease, polyarteritis, scleroderma, ulcerative colitis, Crohn's disease, Sjogren's syndrome, Reiter's syndrome, mixed connective tissue disease (6)Those who have undergone treatment of arthrocentesis or intra-articular injection within 4 weeks prior to registration (7)Received blood transfusion within 12 weeks prior to enrollment, had a whole blood collection of 400 mL or more within 12 weeks or 200 mL or more within 4 weeks, or had a blood component donation within 2 weeks (8) Subjects with a history of drug allergy symptoms that may affect the conduct of this study. (9)Have used drugs (over-the-counter drugs and ethical drugs) or supplements within 1 week prior to registration (10)Subjects with acute infectious diseases within 4 weeks prior to registration (11)Participated in another clinical trial or clinical research (with intervention) within 12 weeks prior to registration (12)Those who deviated from the clinical laboratory standards of the investigational site in the screening test and the clinical examination on the day prior to administration. However, this excludes cases in which the investigator judges that there is no problem with participation in the clinical trial due to physiological fluctuations, etc. (13)Employees of the site, their family members, or persons in a dependent relationship (e.g., husband and wife, parents, children, siblings) with employees of the site involved in this clinical trial, or persons who may consent under coercion. (14)Persons who are dependent on drugs or who are alcoholics (15)Persons with a history of hepatic, renal, or cardiac disease, etc., for which the investigators determines that the conduct of the clinical trial is problematic for ensuring the safety of the subject (16)The subject's partner wishes to become pregnant during the study period or is unable to use a highly effective contraceptive method. (17)Other subjects whom the investigators determines to have problems in participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safty | — |
Secondary
| Measure | Time frame |
|---|---|
| Temporal changes in MRI measurements | — |
Contacts
Public ContactTomoko Terada
Hokkaido University Hospital
Outcome results
None listed