臨床研究等提出・公開システム

Date of registration	Jan. 04, 2023
Last modified on	Feb. 01, 2024
Trial ID	jRCT2073220083

Scientific Title	A Phase 3 single-arm multicenter study of FF-31501 in meniscus tear patients
Public Title	A Phase 3study of FF-31501 in meniscus tear patients

Contact for Scientific Queries	Name	Sakurai Tsutomu
	Affiliation	FUJIFILM Toyama Chemical Co., Ltd
	Address	2-14-1,Kyoubashi,Chuo-ku,Tokyo,Japan
	Telephone	+81-3-6228-3129
	E-mail	fftc-clinicaltrial-info1@fujifilm.com
Contact for Public Queries	Name	Clinical Trial Information Officer
	Affiliation	FUJIFILM Toyama Chemical Co., Ltd
	Address	2-14-1,Kyoubashi,Chuo-ku,Tokyo,Japan
	Telephone	+81-3-6228-3129
	E-mail	fftc-clinicaltrial-info1@fujifilm.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 04, 2023
Actual date of first enrollment		Jan. 24, 2023
Target sample size		18
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.Patients with suspected meniscus flap tear 2.Patients with knee pain 3.Patients with one or more of the following symptoms Feeling stuck in the knee Instability of the knee Knee range of motion impairment Knee joint edema 4.Other
	Exclusion Criteria	1.Patients with poor knee alignment 2.Patients who underwent meniscus surgery or platelet rich plasma therapy 3.Patients with or history of knee ligament injury 4.Diabetic patients with poor glycemic control 5.Patients with the following complications and poor general condition Severe cardiovascular disease Severe liver disease Severe renal dysfunction Severe anemia uncontrolled mental illness Other diseases for which sudden change or worsening of symptoms can be expected during study participation 6.Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period 7.Other
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Meniscus injuries indicated for meniscectomy
Intervention(s)		A single injection of human autologous synovial stem cells under arthroscopy
Primary Outcome(s)		Changes in Lysholm score after injection
Secondary Outcome(s)		Arthroscopic assesment of the meniscus before and 52 weeks after injection of FF-31501 Changes in KOOS after injection Changes in NRS after injection

Primary Sponsor	FUJIFILM Toyama Chemical Co., Ltd

Name of Certified Review Board	Hospital of the University of Occupational and Environmental Health IRB
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka, Fukuoka
Telephone	+81-93-691-7503
E-Mail	rinken@mbox.clnc.uoeh-u.ac.jp
Approval Status	Approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 01, 2024	(this page)	Changes
2	Aug. 09, 2023	Detail	Changes
1	Jan. 04, 2023	Detail

List of change history