臨床研究等提出・公開システム

Efficacy and safety of IK-01 for focal cartilage injury and osteochondritis dissecans,Phase 3 study

Phase 3 study for focal cartilage injury of the knee

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

nfo@hirosaki-li.co.jp

completed

Nov. 14, 2018

Interventional

A multicenter, open-label, randomized, parallel-group comparative study

treatment purpose

3

Main study
(1) Patients with localized traumatic cartilage damage in the knee joint
(2) Patients with an IKDC score of less than 60 during screening
(3) Patients with an ICRS or Outerbridge classification of III or IV
(4) Patients with cartilage damage in the knee joint, with the area of cartilage damage judged to be 2 cm2 or more and 9 cm2 or less
(5) Patients who have not received treatment for MF

Sub-study,cohort 1
In addition to the main study criteria above, patients who meet the following criteria:
(1) Patients who received MF treatment more than one year ago at the time of obtaining consent, but still have cartilage damage, or patients who were deemed ineffective in the main study

Sub-study,cohort 2
(1) Patients with localized osteochondritis dissecans in the knee joint
(2) Patients with an IKDC score of less than 60 at the screening stage
(3) Patients with Nelson classification of III or IV on MRI images
(4) Patients with osteochondritis dissecans with cartilage damage area judged to be 2 cm2 or more and 9 cm2 or less

(1) Patients with a history of treatment with human (autologous) cartilage-derived tissue regenerative medicine products or equivalent investigational products in the affected limb
(2) Patients with cartilage damage or osteochondritis dissecans in both knee joints
(3) Patients with knee osteoarthritis
(4) Patients with two or more cartilage damage sites in one knee joint, or patients with localized cartilage damage requiring treatment in both knee joints
(5) Patients with cartilage damage in the opposing joint surfaces

Both

Cartilage damage in the knee joint/osteochondritis dissecans

IK-01 group
General name, etc.: Human (autologous) cartilage cell processed product (IK-01)
Dosage and administration, method of use: Transplantation to damaged area

MF group
General name, etc.: Microfracture (MFx) method
Dosage and administration, method of use: Bone drilling to damaged area

(1) Change in IKDC score at 52 weeks after surgery (after IK-01 transplantation or MF) compared to preoperative values in patients with traumatic cartilage injury who did not undergo MF

(1) For cohort 1 or 2, evaluate the proportion of subjects who achieved an increase of 20 or more in IKDC score at 52 weeks after surgery.

Sept. 05, 2018