臨床研究等提出・公開システム

Japanese

Date of registration	June. 13, 2022
Last modified on	Feb. 02, 2024
Trial ID	jRCTb050220048

Scientific Title	Safety trial for the treatment of knee osteoarthritis using adipose tissue-derived stem cells by automatic culture (ST-KOA-ADSCs)
Public Title	Treatment of knee osteoarthritis using adipose tissue-derived stem cells (KOA-ADSCs)
Manager (representative manager when conducting as a multicenter joint research)	Satoshi Sobajima

Completion date	June. 13, 2023
Result actual enrolment	0
Baseline Characteristics	In this study, regenerative medicine was not provided.
Participant flow	In this study, regenerative medicine was not provided.
Adverse events	In this study, regenerative medicine was not provided.
Outcome measures	In this study, regenerative medicine was not provided.
Brief summary	There were no entries by the end of the research period for this regenerative medicine, etc., and regenerative medicine, etc. was not provided.
Date of posting of results summaries	Sept. 01, 2023
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTb050220048

Contact for Scientific Queries	Name	Satoshi Sobajima
	Affiliation	Sobajima Clinic
	Address	1F,2F,3F, Clinic Court Higashino, 2-2-6 Ara motokita, Higashiosaka City, Osaka
	Telephone	+81-6-4309-5141
	E-mail	orthohealing@soba-cli.com
Contact for Public Queries	Name	Misako Fujii
	Affiliation	Sobajima Clinic
	Address	1F,2F,3F, Clinic Court Higashino, 2-2-6 Ara motokita, Higashiosaka City, Osaka
	Telephone	+81-6-4309-5141
	E-mail	fujii@soba-cli.com

Target sample size		5
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	-Over 20 years old when obtaining consent -No improvement in standard conservative therapy for insurance indication -Don't request surgical treatment at the time of obtaining consent -Obtain written consent sufficient explanation about this study -Able to comply with a fixed schedule
	Exclusion Criteria	-Patients who have difficulty with subcutaneous liposuction -Patients with cancer -Patients who are using anti-cancer drugs, biologics or immunosuppressants -Patients with active infection -Patients who have recieved this treatmentwithin a month -Patients with serious complicaitons such asheart disease, liver diseaes, lung disease, kidny disease, bleeding tendency, uncontroled diabetes, hypertension, etc. -Patients with a history of drug sensitivity to anesthetics -Other patients judged inappropriate by doctors
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Knee osteoarthiritis
Intervention(s) Code
Intervention(s) Keyword
Intervention(s)		Intraarticular administration of A-ADSCs using a 21G needle with echo guide. Dosing at least 20 million cells in one ingection.
Health Condition(s) Code
Health Condition(s) Keyword
Primary Outcome(s)		Presence or absence of advese event
Secondary Outcome(s)		Clinical score evalution such as WOMAC, JKOM, KOOS (4 weeks, 12 weeks, and 24 weeks after treatment) MRI image evaluation (24 weeks after treatment)

Anticipated date of first enrollment	June. 13, 2022
Actual date of first enrollment
Recruitment status	Complete

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Science and Technology Promotion Division
Secondary Sponsor	Not applicable

Name of Certified Review Board	H-CARM Secified Certified Regenerative M edicine Committee
Address	3-198-1 Takabatake, Kanazawa City, Ishikaw a , Ishikawa, Ishikawa
Telephone	+81-76-220-6332
E-Mail	ccrm@h-carm.com
Approval Status	Approval
Date of approval	Feb. 14, 2022

Secondary ID(s)
Issuing Authority

History of Changes

No	Publication date
3	Feb. 02, 2024	(this page)	Changes
2	April. 17, 2023	Detail	Changes
1	June. 13, 2022	Detail

List of change history