臨床研究等提出・公開システム

Scientific Title	Retrospective Study on the Safety and Therapeutic/Improvement Effects of Intravenous Administration of SHED-CM in ALS Patients
Public Title	Retrospective Study on the Safety and Therapeutic/Improvement Effects of Intravenous Administration of SHED-CM in ALS Patients

Contact for Scientific Queries	Name	Seta Yasuhiro
	Affiliation	Hitonowa Medical
	Address	K-PLAZA 2F 1-7 Rokubancho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6272-8181
	E-mail	info@smartcl-medical.jp
Contact for Public Queries	Name	Sekine Midori
	Affiliation	Hitonowa Medical
	Address	K-PLAZA 2F 1-7 Rokubancho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6272-8181
	E-mail	info@smartcl-medical.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 25, 2023
Actual date of first enrollment
Target sample size		28
Study Type		Observational
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 who visited our clinic between January 1, 2022 and November 30, 2023 and have been diagnosed with ALS 2. male and female patients aged between 16 and 90 years old 3. ALSFRS-R score of 12 or more at the time of initial visit
	Exclusion Criteria	1. Patients who have a tracheostomy at the time of visit. 2. Patients who have expressed their refusal to participate in this study.
	Age Minimum	16age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		amyotrophic lateral sclerosis (ALS)
Intervention(s)
Health Condition(s) Keyword		ALS
Intervention(s) Keyword
Health Condition(s) Code		8B60.0
Intervention(s) Code
Primary Outcome(s)		Adverse Events
Secondary Outcome(s)		1. check the amount and rate of change in each ALSFRS-R score and the total ALSFRS-R score 2. respiratory function test 3. grip strength

Primary Sponsor	Hitonowa Medical Seta Yasuhiro

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	JSCSF Ethics Review Committee
Address	Shimmakichobiru 6F 1-8-16 Yaesu, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-5542-1597
E-Mail	mail@jscsf.net
Approval Status	Approval
Date of approval	Dec. 25, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)	無し
Issuing Authority	None

Countries of Recruitment（Except Japan）	none