臨床研究等提出・公開システム

Japanese

Date of registration	July. 12, 2024
Last modified on	May. 12, 2025
Trial ID	jRCT2032240214

Scientific Title	A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction
Public Title	A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction

Contact for Scientific Queries	Name	Okazaki Ken
	Affiliation	Tokyo Women's Medical University Hospital
	Address	8-1,Kawada-cho,Shinjuku-ku,Tokyo,Japan
	Telephone	+81-3-3353-8111
	E-mail	okazaki.ken@twmu.ac.jp
Contact for Public Queries	Name	Kanemoto Mitsuhide
	Affiliation	CoreTissue BioEngineering Inc.
	Address	Life Science Research Center 301 Suehirocho 1-1-43, Tsurumi-ku, Yokohama, Kanagawa JAPAN
	Telephone	+81-45-642-5455
	E-mail	mitsuhide.kanemoto@coretissue.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 15, 2024
Actual date of first enrollment		Nov. 25, 2024
Target sample size		64
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Age: 18 years old or older and under 45 years old. Patients with anterior cruciate ligament injury who are candidates for reconstruction surgery.
	Exclusion Criteria	Chronic anterior cruciate ligament injury (injury occurred more than 12 months ago). History of knee surgery, including anterior cruciate ligament surgery on the index side. Complication or history cruciate ligament injury on the opposite side, history of total knee arthroplasty, osteotomy around the knee, or osteosynthesis around the knee on the opposite side. Meniscus injury that requires extensive resection and is impossible to suture on the index side, collateral ligament injury or posterior cruciate ligament injury of 2 or more on the index side. Complication of osteoarthritis of the knee on the index side, KL classification 2 or higher. Complications of cartilage damage that cannot be treated by drilling or microfracture on the index side. Patients with infection in the index knee or inflammatory joint disease such as rheumatoid arthritis. Patients undergoing radiation therapy, chemotherapy, or both. Patients currently receiving treatment with systemic steroids, immunosuppressants, or both. Patients who are allergic to bovine products (e.g. meat). Patients who cannot discontinue returning to sports until 9 months after reconstruction surgery. Pregnant, breastfeeding and possibly pregnant patients. Female patients of childbearing potential and male patients who cannot agree to contraception for at least one year after reconstruction surgery. Patients who participated in other clinical trials within 4 weeks prior to reconstruction surgery.
	Age Minimum	18age old over
	Age Maximum	45age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients with anterior cruciate ligament injury who are candidates for reconstruction surgery
Intervention(s)		Anterior cruciate ligament reconstruction using the investigational device or autologous tendon (hamstring tendon)
Health Condition(s) Keyword		Anterior cruciate ligament injury, anterior cruciate ligament rupture, anterior cruciate ligament reconstruction
Intervention(s) Keyword		Anterior cruciate ligament reconstruction, CT-ACL001
Health Condition(s) Code		C26.558.554.213
Intervention(s) Code		E04.555.110.026
Primary Outcome(s)		IKDC Subjective Score
Secondary Outcome(s)		Anterior tibial translation. Donor site morbidity. Knee flexion strength. Tegner activity score. Incidence of additional surgery on the affected side. Graft rupture rate. Joint effusion. Adverse events/malfunction rates.

Primary Sponsor	CoreTissue BioEngineering Inc.

Name of Certified Review Board	Tokyo Women's Medical University Institutional Review Board
Address	8-1,Kawada-cho,Shinjuku-ku,Tokyo,Japan, Tokyo
Telephone	+81-3-3353-8111
E-Mail	chiken.bm@twmu.ac.jp
Approval Status	Approval
Date of approval	Oct. 11, 2024

Name of Certified Review Board	Hokkaido University Hospital Institutional Review Board
Address	Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan, Tokyo
Telephone	+81-11-706-7061
E-Mail	tiken@med.hokudai.ac.jp
Approval Status	Approval
Date of approval	Oct. 11, 2024

Name of Certified Review Board	Institutional Review Board of Hirosaki University Hospital
Address	53 Honcho, Hirosaki, Aomori, Japan, Tokyo
Telephone	+81-172-39-5295
E-Mail	cksenta@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 11, 2024

Name of Certified Review Board	Kobe University Hospital Institutional Review Board
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo Prefecture, JAPAN, Tokyo
Telephone	+81-78-382-5652
E-Mail	chiken@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 11, 2024

Name of Certified Review Board	Hiroshima University hospital IRB
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan, Tokyo
Telephone	+81-82-257-5596
E-Mail	hugcp@hiroshima-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 11, 2024

Name of Certified Review Board	Juntendo University Hospital Institutional Review Board
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-3814-5672
Date of approval	Oct. 11, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	May. 12, 2025	(this page)	Changes
2	Aug. 31, 2024	Detail	Changes
1	July. 12, 2024	Detail

List of change history