臨床研究等提出・公開システム

Date of registration	April. 03, 2024
Last modified on	April. 03, 2024
Trial ID	jRCT1051240003

Scientific Title	The Study of the treatment for Chronic Pain from knee osteoarthritis with Human Mesenchymal Stem Cell Conditioned Medium
Public Title	A study of treatment of chronic pain 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	+81-3-5962-6485
	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	+81-3-5962-6485
	E-mail	atsu5426@yahoo.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 03, 2024
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Individuals who is diagnosed as knee osteoarthritis. 2. Those for whom satisfactory pain relief effects were not observed with standard therapy. 3. Individuals who do not wish to undergo treatment with drugs commonly used in standard therapy for chronic pain due to concerns about side effects, and have been deemed suitable for chronic pain treatment with conditioned medium by a 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> Individuals meeting any of the following conditions will be excluded from the study: 1. Individuals without pain other than nociplastic pain. 2. Patients with a history or suspicion of dementia 3. Users of narcotics or stimulants. 4. 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		Chronic Pain from knee osteoarthritis
Health Condition(s) Code		D059350
Primary Outcome(s)		1. Effect of pain on daily life 2. Pain intensity (Numerical Rating Scale; NRS) 3. Kellgren-Lawrence grade
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	Mar. 27, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none