臨床研究等提出・公開システム

An open-label, multi-center exploratory study to investigate the efficacy and safety of autologous chondrocyte processed product (IK-01) for knee osteoarthritis

Exploratory study of IK-01 for knee osteoarthritis

Otsuka Koji

Hirosaki Lifescience Innovation, Inc.

4th Floor, 9-6, Nibancho, Chiyoda Ku, Tokyo 102-0084, Japan

info@hirosaki-li.co.jp

Regenerative medicine Products Development

Hirosaki Lifescience Innovation, Inc.

4th Floor, 9-6, Nibancho, Chiyoda Ku, Tokyo 102-0084, Japan

+81-3-6457-9861

info@hirosaki-li.co.jp

Complete

Sept. 01, 2022

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

Both

Osteoarthritis of the knee

IK-01 is transplanted or IK-01 is transplanted simultaneously with high tibial osteotomy in patients with knee osteoarthritis

Change from baseline in the WOMAC total score at 52 weeks post-transplantation

+81-78-382-5111

Aug. 24, 2022

No

none