Osteoarthritis of the knee
Conditions
Interventions
The investigational extracellular particles (EPs), at a dose of 1x10^10 particles, will be prepared as a 1 mL suspension and administered as a single intra-articular injection into the knee joint.
Sponsors
Ohtake Takayasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be included: 1. Presence of knee osteoarthritis (OA) confirmed by symptoms consistent with the Clinical Practice Guideline for the Management of Osteoarthritis of the Knee (e.g., knee pain, stiffness, discomfort when ascending or descending stairs) and/or by imaging findings. 2. Clinical severity of knee osteoarthritis classified as Kellgren-Lawrence grade II or III 3. Pain intensity of 50 mm or greater on the Visual Analogue Scale (VAS). 4. Age 18 years or older at the time of obtaining consent. 5. Written informed consent voluntarily provided by the subject after receiving a sufficient explanation regarding participation in this study.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this study: 1. Presence or history of malignant tumor within the past 5 years. 2. History of total knee arthroplasty. 3. Presence of local infection in the knee joint. 4. Body mass index (BMI) of 30 or higher. 5. Receipt of intra-articular injection of steroid or hyaluronic acid within one month prior to the date of informed consent. 6. Pregnant or breastfeeding women 7. Any other condition judged by the principal investigator to make the subject inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety from the start of administration to 4 weeks after administration (occurrence of adverse events requiring treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee pain score (Visual Analogue Scale: VAS) and presence or absence of range of motion limitation from the start of administration to 4 weeks after administration. Adverse events observed from the start of administration to 4 weeks after administration. | — |
Contacts
Public ContactTakayasu Ohtake
Shonan Kamakura General Hospital
Outcome results
None listed