臨床研究等提出・公開システム

Date of registration	Feb. 20, 2025
Last modified on	Feb. 20, 2025
Trial ID	jRCT2053240275

Scientific Title	Confirmatory study to investigate the efficacy and safety of autologous chondrocyte processed product (IK-01) for knee osteoarthritis
Public Title	Confirmatory study of IK-01 for knee osteoarthritis

Contact for Scientific Queries	Name	Nagashima Takafumi
	Affiliation	CynosBio, Inc.
	Address	Nihonbashi Horidomecho, 1-3-15, Chuo-ku, Tokyo, 103-0012, Japan
	Telephone	+81-3-6457-9861
	E-mail	info@hirosaki-li.co.jp
Contact for Public Queries	Name	Regenerative medicine Products Development
	Affiliation	CynosBio, Inc.
	Address	Nihonbashi Horidomecho, 1-3-15, Chuo-ku, Tokyo, 103-0012, Japan
	Telephone	+81-3-6457-9861
	E-mail	info@hirosaki-li.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 20, 2025
Target sample size		54
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion Criteria	- 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 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 8 weeks or more after surgery can be enrolled - Patients who are judged to be inappropriate by the principal investigator or sub investigator
	Age Minimum	20age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Osteoarthritis of the knee
Intervention(s)		IK-01 is transplanted or Hyaluronic acid is administered in patients with knee osteoarthritis
Primary Outcome(s)		Change from baseline in the WOMAC total score at 52 weeks post-transplantation of IK-01 or post-treatment of Hyaluronic acid
Secondary Outcome(s)		Lysholm score, Pain VAS score and so on

Primary Sponsor	CynosBio, Inc.

Secondary Sponsor

Name of Certified Review Board	Kobe University Hospital Institutional Review Board
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo, Hyogo
Telephone	+81-78-382-5111
E-Mail	chiken@med.kobe-u.ac.jp
Date of approval	Feb. 12, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none