臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 26, 2025
Last modified on	July. 22, 2025
Trial ID	jRCTs051240303

Scientific Title	Efficacy of Extracellular Vesicle-Rich Conditioned Medium from Adipose Tissue-Derived Human Mesenchymal Stem Cells for Androgenetic Alopecia: A Single-Center Intervention Study (EVERIMEN Study)
Public Title	EVERIMEN Study (EVERIMEN Study)

Contact for Scientific Queries	Name	Nakayama Hiroyuki
	Affiliation	ELULA CLINIC
	Address	KOWA Higashinotoin Bldg. 1F, 275-1 Ogisakayacho, Ayanokoji-sagaru, Higashinotoin-dori, Shimogyo-ku, Kyoto-shi, Kyoto
	Telephone	+81-75-754-8852
	E-mail	info@elulaclinic.com
Contact for Public Queries	Name	Nakayama Hiroyuki
	Affiliation	ELULA CLINIC
	Address	KOWA Higashinotoin Bldg. 1F, 275-1 Ogisakayacho, Ayanokoji-sagaru, Higashinotoin-dori, Shimogyo-ku, Kyoto-shi, Kyoto
	Telephone	+81-75-754-8852
	E-mail	info@elulaclinic.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 01, 2025
Actual date of first enrollment		June. 06, 2025
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients diagnosed with androgenetic alopecia in males 2) Patients diagnosed with Hamilton-Norwood classification type II Vertex, III Vertex, IV, and V 3) Patients who have used minoxidil, 5-alpha reductase inhibitors, or both in the past (including ongoing use) but are dissatisfied with the results and wish to receive stem cell supernatant fluid 4) Patients aged 18 years or older 5) Patients who have given written informed consent
	Exclusion Criteria	1) Patients undergoing treatment for malignant tumours 2) Patients with concurrent hair loss other than androgenetic alopecia 3) Patients who have previously undergone stem cell supernatant solution treatment for the scalp 4) Patients who have started or changed their treatment for androgenetic alopecia within 6 months prior to obtaining consent 5) Patients currently participating in another clinical trial 6) Patients deemed inappropriate as subjects by the principal investigator (subinvestigator)
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		androgenetic alopecia
Intervention(s)		The investigational drug Stemsap-A will be administered via intradermal injection into the scalp dermis. This will be performed a total of 8 times at 4-week intervals.
Health Condition(s) Keyword		androgenetic alopecia
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change in scalp hair density from baseline to 32 weeks of treatment (strands/cm2)
Secondary Outcome(s)		1) Changes in scalp hair density (strands/cm2) 2) Modified Global Photographic Assessment (MGPA) score at 16, 32 and 52 weeks post-treatment 3) Changes in Dermatology Life Quality Index (DLQI) 4) Subject satisfaction with treatment at 32 and 52 weeks

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Review Board of the Nara Medical University
Address	840 Shijo-cho, Kashihara-shi, Nara
Telephone	+81-744-29-8835
E-Mail	ethics_nara@naramed-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 14, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 22, 2025	(this page)	Changes
2	July. 18, 2025	Detail	Changes
1	Mar. 26, 2025	Detail

List of change history