臨床研究等提出・公開システム

Date of registration	Oct. 02, 2024
Last modified on	Oct. 02, 2024
Trial ID	jRCT1051240143

Scientific Title	Study on the Treatment of Chronic Fatigue Using Human-Derived Mesenchymal Stem Cell Conditioned Medium
Public Title	Study on Treatment of Chronic Fatigue with MSC-CM

Contact for Scientific Queries	Name	Atsutomo Morishima
	Affiliation	Omotesando Wellness Clinic
	Address	North Aoyama Building B1, 3-9-8 Kitaaoyama, Minato City, Tokyo 107-0061, Japan
	Telephone	+81-359626485
	E-mail	atsu5426@yahoo.co.jp
Contact for Public Queries	Name	Atsutomo Morishima
	Affiliation	Omotesando Wellness Clinic
	Address	North Aoyama Building B1, 3-9-8 Kitaaoyama, Minato City, Tokyo 107-0061, Japan
	Telephone	+81-359626485
	E-mail	atsu5426@yahoo.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 02, 2024
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Those who have not achieved satisfactory therapeutic effects with standard treatments. 2. Those who do not wish to use existing medications due to concerns about side effects and are deemed suitable for treatment with culture supernatant by their physician.. The patient selection criteria are as follows: <Inclusion Criteria> Patients meeting the following criteria will be considered eligible: 1. Individuals aged 18 and above. 2. Individuals with normal decision-making capacity. 3. Individuals who have been provided with the informed consent document regarding this treatment, received sufficient explanation, and can provide voluntary written consent. 4. Individuals for whom the attending physician has recognized the necessity of treatment.
	Exclusion Criteria	Exclusion Criteria Anyone who meets any of the following conditions will be excluded: 1. Users of narcotics or stimulants. 2. Those deemed unsuitable by the attending physician.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic Fatigue
Health Condition(s) Code		D005600
Primary Outcome(s)		1. atigue Visual Analogue Scale (VAS) 2.Chalder Fatigue Scale
Secondary Outcome(s)		subjective symptoms, etc.

Primary Sponsor	Omotesando Wellness Clinic

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Safety Assessment and Clinical Research in Japan
Address	13-16 Sanjo Minamicho, Ashiya City, Hyogo
Telephone	+81-797-22-5511
E-Mail	jpgh@ace.odn.ne.jp
Approval Status	Approval
Date of approval	July. 24, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none