臨床研究等提出・公開システム

Scientific Title	A study of treatment of cancer cachexia and for reducing side effects of standard cancer treatment with human-derived mesenchymal stem cell conditioned medium
Public Title	A study of treatment of cancer cachexia and for reducing side effects of cancer treatment with conditioned medium

Contact for Scientific Queries	Name	Inami Norihito Norihito
	Affiliation	Seihoku Clinic
	Address	775 Takawa, Oshibedani-cho, Nishi-ku, Kobe
	Telephone	+81-78-998-1101
	E-mail	inami@shhc.jp
Contact for Public Queries	Name	Murata Yoshiki
	Affiliation	Seihoku Clinic
	Address	775 Takawa, Oshibedani-cho, Nishi-ku, Kobe
	Telephone	+81-78-998-1101
	E-mail	mochizuki@shhc.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 19, 2022
Actual date of first enrollment
Target sample size		20
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients who want to reduce side effects associated with cancer cachexia and cancer treatment. 2. Patients who have been judged by the doctor to be optimally treated with conditioned medium. <Inclusion criteria> Target patients who meet the following criteria. 1. 18 years old and over 2. Have normal consent ability 3. Patients who can obtain their free will consent in writing 4. Patients whose doctor have recognized the need for treatment
	Exclusion Criteria	<Exclusion criteria> Patient who meet any of the following conditions are excluded 1. Have a history of or suspected of dementia 2. Users of narcotics or stimulants 3. Pregnant, breastfeeding 4. Judged unsuitable by the doctor
	Age Minimum	18age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cancer cachexia, Side effects of cancer treatment
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Common tumor markers tested during previous treatment,high-sensitive CRP, adiponectin, total antioxidant capacity, GDF15, galectin-3, grip strength, body composition, Image diagnosis by CT
Secondary Outcome(s)		subjective symptoms, etc.

Primary Sponsor	Seihoku Clinic

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Seihoku clinic ethics committee
Address	775 Takawa, Oshibedani-cho, Nishi-ku, Kobe, Hyogo
Telephone	+81-78-998-1101
E-Mail	mochizuki@shhc.jp
Approval Status	Approval
Date of approval	Aug. 19, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none