臨床研究等提出・公開システム

Scientific Title	Evaluation of knee function and safety after treatment of articular cartilage damage in knee joints with allogeneic induced pluripotent stem (iPS) cell-derived cartilage.
Public Title	Evaluation of knee function and safety after treatment of knee articular cartilage damage with iPS-cell-derived cartilage.

Contact for Scientific Queries	Name	Matsuda Shuichi
	Affiliation	Kyoto University Hospital
	Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
	Telephone	+81-75-751-3366
	E-mail	seikei@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Kuriyama Shinichi
	Affiliation	Kyoto University Hospital
	Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
	Telephone	+81-75-751-3366
	E-mail	seikei@kuhp.kyoto-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 16, 2022
Actual date of first enrollment
Target sample size		4
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who received and completed knee treatment with iPS-cell-derived cartilage.
	Exclusion Criteria	Patients whom the doctors considered inappropriate for the study. 1) Patients with new-onset systematic diseases unrelated to the surgery that can not come to the hospital.. 2) Patients who have difficulty coming to the hospital due to relocation. 3) Patients with new-onset psychiatric disorders that may influence the conduct and evaluation of this study.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Damage of articular cartilage of the Knee
Intervention(s)
Health Condition(s) Keyword		Articular cartilage damage, Articular cartilage disorder, Osteoarthritis
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Evaluation of clinical outcomes of patients who received treatment with iPS-cell-derived cartilage for at least one year postoperatively.
Secondary Outcome(s)		Evaluation of safety of patients who received treatment with iPS-cell-derived cartilage for at least one year postoperatively.

Primary Sponsor	Kyoto University Hospital

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoecho, Sakyo-ku, Kyoto, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 07, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none