臨床研究等提出・公開システム

Date of registration	Aug. 03, 2026
Last modified on	Aug. 03, 2026
Trial ID	jRCT1051260123

Scientific Title	Research on the Treatment of Diabetes and Diabetic Complications with Human-Derived Mesenchymal Stem Cell Conditioned Medium
Public Title	Research on the Treatment of Diabetes and Diabetic Complications with MSC-CM

Contact for Scientific Queries	Name	Shen Zhuo
	Affiliation	Heiwa Clinic
	Address	VORT Kamiyacho II 2F, Azabudai 1-7-3, Minato-ku, Tokyo
	Telephone	+81-80-3697-0369
	E-mail	shenzhuojapan@hotmail.com
Contact for Public Queries	Name	Shen Zhuo
	Affiliation	Heiwa Clinic
	Address	VORT Kamiyacho II 2F, Azabudai 1-7-3, Minato-ku, Tokyo
	Telephone	+81-80-3697-0369
	E-mail	shenzhuojapan@hotmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 24, 2024
Target sample size		20
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Individuals who did not experience satisfactory effects in the treatment of diabetes or diabetic complications 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. <Inclusion Criteria> Patients meeting the following criteria will be included: 1. Individuals aged 18 years or older. 2. Individuals who have undergone at least two tests showing fasting blood glucose levels of >= 126 mg/dl, 75g OGTT 2-hour values of >= 200 mg/dl, or random blood glucose levels of >= 200 mg/dl. 3. Individuals with normal capacity to consent. 4. 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. 5. Individuals for whom the attending physician has recognized the necessity of treatment.
	Exclusion Criteria	<Exclusion Criteria> Individuals meeting any of the following conditions should 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		Diabetes and Diabetic Complications
Health Condition(s) Keyword		Diabetes, Diabetic Retinopathy, Diabetic Nephropathy, Diabetic Neuropathy, Diabetic Foot Complications, Cardiovascular Diseases
Health Condition(s) Code		D003920
Primary Outcome(s)		Conduct blood tests, including blood glucose, HbA1c, renal function, blood pressure, etc., based on the diagnostic criteria for diabetes. Assess the severity of symptoms if values exceed reference ranges. 1. Perform necessary blood tests according to symptoms. Simultaneously, store a 2 mL serum sample. 2. Approximately one month after administration, evaluate the chief complaints of symptoms and conduct blood tests to assess improvements in symptoms, impact on daily life, etc.

Primary Sponsor	Heiwa Clinic

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