Exploratory study of IK-01 for knee osteoarthritis

JRCT ID: jRCT2053220084

Registered date:02/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoarthritis of the knee
• Date of first enrollment: 01/09/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): IK-01 is transplanted or IK-01 is transplanted simultaneously with high tibial osteotomy in patients with knee osteoarthritis

Outcome(s)

• Primary Outcome: Change from baseline in the WOMAC total score at 52 weeks post-transplantation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Otsuka Koji