臨床研究等提出・公開システム

Scientific Title	The Study of the Treatment for General Fatigue with Human Mesenchymal Stem Cell Conditioned Medium
Public Title	A study of treatment of General Fatigue with MSC-CM

Contact for Scientific Queries	Name	Hori Atsushi
	Affiliation	IGT Clinic
	Address	3-41 Rinkuoraiminami, Izumisano, Osaka 598-0047
	Telephone	+81-72-463-3811
	E-mail	horiat@igtc.jp
Contact for Public Queries	Name	Torii Masahiro
	Affiliation	IGT Clinic
	Address	3-41 Rinkuoraiminami, Izumisano, Osaka 598-0047
	Telephone	+81-72-463-3811
	E-mail	toriim@igtc.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 28, 2024
Actual date of first enrollment
Target sample size
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Individuals who did not experience satisfactory effects with standard therapy. 2. Individuals who are determided by the doctor to be appropriate for receive the treatment with the conditioned medium. <Eligibility Criteria> Patients meeting the following criteria are eligible: 1. Individuals aged 18 years or older. 2. Individuals with normal capacity to consent. 3. Individuals who have been provided with the informed consent document for this treatment, have received sufficient explanation, and are capable of providing written consent freely and voluntarily. 4. Individuals for whom the attending physician has recognized the necessity of treatment.
	Exclusion Criteria	<Exclusion Criteria> Individuals meeting any of the following conditions will be excluded: 1. Users of narcotics or stimulants. 2. Individuals deemed inappropriate by the attending physician.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		General fatigue
Intervention(s)
Health Condition(s) Keyword		Fatigue
Intervention(s) Keyword
Health Condition(s) Code		D015673
Intervention(s) Code
Primary Outcome(s)		Medical examination by interview
Secondary Outcome(s)		subjective symptoms, etc.

Primary Sponsor	IGT clinic

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	IGT Clinic Ethics review committee
Address	3-41 Rinkuoraiminami, Izumisano, Osaka 598-0047, Osaka
Telephone	+81-72-463-0855
E-Mail
Approval Status	Approval
Date of approval	Feb. 28, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 16, 2024	(this page)	Changes
1	July. 22, 2024	Detail

List of change history