臨床研究等提出・公開システム

Date of registration	May. 07, 2024
Last modified on	May. 07, 2024
Trial ID	jRCT1051240018

Scientific Title	The Study of the Treatment for Erectile Dysfunction with Human Mesenchymal Stem Cell Conditioned Medium
Public Title	A study of treatment of ED with MSC-CM

Contact for Scientific Queries	Name	Hirayama Takashi
	Affiliation	OSAKA UMEDA SHINSHI CLINIC
	Address	Nishi-Hankyu Bldg.B1F,2-1-18,Shibata,kita-ku,Osaka-shi,Osaka
	Telephone	+81-6-6373-0404
	E-mail	hirayama@gents-clinic.com
Contact for Public Queries	Name	Hirayama Takashi
	Affiliation	OSAKA UMEDA SHINSHI CLINIC
	Address	Nishi-Hankyu Bldg.B1F,2-1-18,Shibata,kita-ku,Osaka-shi,Osaka
	Telephone	+81-6-6373-0404
	E-mail	hirayama@gents-clinic.com

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 07, 2024
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	"1. Those for whom satisfactory improvement effects were not observed 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 have been deemed suitable for 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. Users of narcotics or stimulants. 2. Individuals deemed inappropriate by the attending physician"
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		Erectile dysfunction
Primary Outcome(s)		Evaluation by IIEF-5
Secondary Outcome(s)		subjective symptoms, etc.

Primary Sponsor	OSAKA UMEDA SHINSHI 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, 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