臨床研究等提出・公開システム

Date of registration	Nov. 12, 2024
Last modified on	Nov. 12, 2024
Trial ID	jRCT1051240182

Scientific Title	Research on chronic pain treatment with human-derived mesenchymal stem cell conditioned medium
Public Title	Research on chronic pain treatment with MSC-CM

Contact for Scientific Queries	Name	Takome Shoka
	Affiliation	Seishin Medical Clinic
	Address	Collect Mark Meieki 4-chome 6F, 4-11-1 Meieki Nakamura-ku, Nagoya-shi, Aichi 450-0002
	Telephone	+81-52-462-9838
	E-mail	seishinmedicalclinic@gmail.com
Contact for Public Queries	Name	Takome Shoka
	Affiliation	Seishin Medical Clinic
	Address	Collect Mark Meieki 4-chome 6F, 4-11-1 Meieki Nakamura-ku, Nagoya-shi, Aichi 450-0002
	Telephone	+81-52-462-9838
	E-mail	seishinmedicalclinic@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 24, 2024
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Individuals who did not experience satisfactory pain relief effects with standard therapy. 2. Individuals who do not wish to undergo treatment with drugs commonly used in standard therapy due to concerns about side effects, and whose physicians have determined that treatment with conditioned medium is appropriate for chronic pain relief. <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 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
Health Condition(s) Keyword		Arthritis pain, Back pain, Persistent pain, Neuropathic pain, Musculoskeletal pain
Health Condition(s) Code		D009132
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

Primary Sponsor	Seishin Medical 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	April. 24, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none