臨床研究等提出・公開システム

Date of registration	Feb. 25, 2025
Last modified on	Feb. 25, 2025
Trial ID	jRCT1051240277

Scientific Title	A Study on the Treatment of Spinal Canal Stenosis with Human-Derived Mesenchymal Stem Cell Conditioned Medium
Public Title	Spinal Stenosis Treatment with conditioned Medium

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

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 25, 2025
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1.Individuals who have not experienced satisfactory treatment effects with standard treatments for spinal canal stcnosis. 2.Individuals who,due to concerns about side effects,do not with to undergo standard treatments and have been determined by a doctor to be suitable for treatment with conditioned medium from human-derived mesenchymal stem cells. Application Criteria: Patients who meet the following criteria are eligble: 1.Individuals aged 18 years or older. 2.Individuals who possess normal capacity to consent. 3.Individuals who have been given a thorough explanation and have received an informed consent document related to this treatment, and can provide written consent voluntarily.4.4.Individuals whose attending physician recognizes the necessity of the treatment,
	Exclusion Criteria	Exclusion Criteria: Individuals who meet any of ffollowing conditions will be excluded 1.Users of narcotics or stimulants. 2.lndividualls deemed unsuitable by the attending doctor.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		spinal canal stenosis
Health Condition(s) Code		D013123
Primary Outcome(s)		Subjective Symptoms and Blood CRP Measurement
Secondary Outcome(s)		Measurement of S100B.TNF-a.and CRP in Cerebrospinal Fluid

Primary Sponsor	Seihoku Clinic

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	ikami@shhc.jp
Approval Status	Approval
Date of approval	Nov. 01, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none