Exploratory study of IK-01 for knee osteoarthritis
- Conditions
- Osteoarthritis of the knee
- Registration Number
- JPRN-jRCT2053220084
- Lead Sponsor
- Otsuka Koji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Patients who have provided written informed consent using an IRB-approved explanation/consent form
- Patients aged 20 to less than 75 years at the time of informed consent
- Patients diagnosed with knee osteoarthritis according to the ACR classification criteria for knee osteoarthritis (clinical findings and X-ray imaging findings) during the screening period
- Patients diagnosed with knee osteoarthritis of Kellgren-Lawrence grade 2 or 3 on standing frontal X-ray findings during the screening period
- Patients have multiple arthropathies in the lower extremities
- Patients with a history of or need to undergo surgery such as knee meniscectomy or suturing at the time of informed consent. However, if there is a history of meniscal resection or suturing, patients who have passed a certain period (8 weeks or more) after surgery can be enrolled
- Patients with a history of or need surgery such as ligament reconstruction for ligament damage of the evaluation target knee at the time of informed consent. However, patients who have passed a certain period (8 weeks or more) after surgery can be enrolled
- Patients who are judged to be inappropriate by the principal investigator or sub investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in the WOMAC total score at 52 weeks post-transplantation
- Secondary Outcome Measures
Name Time Method