臨床研究等提出・公開システム

Japanese

Date of registration	July. 22, 2024
Last modified on	Oct. 15, 2024
Trial ID	jRCT1051240098

Scientific Title	The study of the Treatments with Human-Derived Mesenchymal Stem Cell Conditioned Medium for Pains
Public Title	The study of the treatment with MSC-CM for pains

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	To 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 pain relief 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 who do not have pains except nociplastic pain. 3. 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		Pain
Intervention(s)
Health Condition(s) Keyword		Arthritis pain,Back pain,Persistent pain,Neuropathic pain,Musculoskeletal pain
Intervention(s) Keyword
Health Condition(s) Code		D009132
Intervention(s) Code
Primary Outcome(s)		Assessment of pain (ache) in terms of subjective symptoms of the research participants, evaluating the following items: 1)Impact of pain on daily life 2) Pattern of pain 3) Intensity of pain (Numerical Rating Scale; NRS) 4) Location of pain 5)Nature of pain
Secondary Outcome(s)

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. 15, 2024	(this page)	Changes
1	July. 22, 2024	Detail

List of change history