臨床研究等提出・公開システム

Date of registration	Dec. 23, 2022
Last modified on	Dec. 23, 2022
Trial ID	jRCT1010220030

Scientific Title	Analysis of DNA methylation changes in bone marrow mesenchymal stem cell therapy
Public Title	DNA methylation analysis in MSC therapy

Contact for Scientific Queries	Name	Sasaki Masanori
	Affiliation	Sapporo Medical University
	Address	S1W17, Chuo-ku, Sapporo, Hokkaido
	Telephone	+81-116112111
	E-mail	msasaki@sapmed.ac.jp
Contact for Public Queries	Name	Sasaki Masanori
	Affiliation	Sapporo Medical University
	Address	S1W17, Chuo-ku, Sapporo, Hokkaido
	Telephone	+81-116112111
	E-mail	msasaki@sapmed.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 23, 2022
Target sample size		50
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients newly admitted to Sapporo Medical University Hospital for the administration of MSCs who are able to obtain consent will be included. The scope of the study includes physician-initiated clinical trials using MSCs (STR01-01, STR01-02, STR01-03, STR01-04, STR01-05, and STR01-08 studies) and patients undergoing treatment with Stemilac Injection who are judged to be capable of safely obtaining blood samples. Subjects.
	Exclusion Criteria	(1) Cases in which consent to participate in the research could not be obtained. (2). cases in which it is considered difficult to collect specimens safely.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		brain injury etc
Health Condition(s) Code		D001930
Primary Outcome(s)		DNAge (DNAge Epigenetic Aging Clock)

Primary Sponsor	Masanori Sasaki

Secondary Sponsor

Name of Certified Review Board	Sapporo Medical University Hospital Institutional Review Board
Address	S1W17, Chuo-ku, Sapporo, Hokkaido
Telephone	+81-116112111
Approval Status	Approval
Date of approval	July. 14, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none