臨床研究等提出・公開システム

Date of registration	Sept. 22, 2022
Last modified on	Dec. 12, 2023
Trial ID	jRCT1030220346

Scientific Title	A study of the safety and sustainability of pain therapy with human adipose-derived mesenchymal stem cell cond itioned medium
Public Title	A study of the safety and sustainability of pain therapy with conditioned medium

Contact for Scientific Queries	Name	Ueda Yasuo
	Affiliation	SAWAI Hospital
	Address	Funahasi-cho 8, Nara-shi, Nara 630-8258, Japan
	Telephone	+81-742-23-30861
	E-mail	toukatsu-yo@eos.ocn.ne.jp
Contact for Public Queries	Name	Ueda Yasuo
	Affiliation	SAWAI Hospital
	Address	Funahasi-cho 8, Nara-shi, Nara 630-8258, Japan
	Telephone	+81-742-23-30861
	E-mail	toukatsu-yo@eos.ocn.ne.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 03, 2022
Actual date of first enrollment		Sept. 26, 2022
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients with chronic pain 2. Patients who did not have a satisfactory pain relief effect with standard treatment 3. Patients over 18 years old 4. Patients with normal consent ability 5. Patients who can obtain their free will consent in writing 6. Patients whose doctor recognizes the need for treatment
	Exclusion Criteria	1. Patients with a history or suspicion of malignant tumor or dementia 2. Drug and stimulant users 3. Patients with no pain other than psychogenic pain 4. Patients who do not understand and agree with this treatment 5. Pregnant 6. Patients that the doctor in charge deems inappropriate
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic Pain
Health Condition(s) Code		D059350
Primary Outcome(s)		Subjective symptoms 1. Effect of pain on daily life 2. Pain intensity (Numerical Rating Scale; NRS) 3. Pain area

Primary Sponsor	SAWAI Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Medical Ai Ethics Committee
Address	4-3-11 Tsukiji, Chuo-ku, Tokyo, Tokyo
Telephone	+81-90-3149-7743
E-Mail	magk@magk.co.jp
Approval Status	Approval
Date of approval	June. 03, 2022

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Dec. 12, 2023	(this page)	Changes
2	Oct. 28, 2022	Detail	Changes
1	Sept. 22, 2022	Detail

List of change history