RecruitingPhase 2NCT07693244

Exosome Therapy for Male Androgenetic Alopecia

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Male Androgenetic Alopecia

Sponsor

Zhang Han

Enrollment

120 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Androgenetic alopecia (AGA)

Summary

The goal of this clinical trial is to learn if local scalp injection of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) can treat androgenetic alopecia (AGA) in male patients with AGA. The main question it aims to answer is: Does hUCMSC-Exos injection improve hair regrowth compared with placebo? Researchers will compare hUCMSC-Exos injection to placebo injection to see if hUCMSC-Exos leads to superior efficacy in hair follicle regeneration, as measured by changes in hair density, hair thickness, and patient-reported outcomes. Participants will: Receive randomized, double-blinded local scalp injections of either hUCMSC-Exos or placebo Attend scheduled follow-up visits for hair assessment and safety monitoring Undergo photography, trichoscopy, and complete quality-of-life or psychosocial burden questionnaires as applicable

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

Participants must meet all of the following criteria to be eligible for enrollment:
Male subjects aged 18 to 55 years;
Diagnosis of androgenetic alopecia classified as Norwood-Hamilton grade III-V;
Stable pattern of hair loss for at least 6 months prior to screening;
Willingness to refrain from using any other hair loss treatments during the study period and for 6 months after completion of treatment.

Exclusion Criteria9

Participants meeting any of the following criteria will be excluded:
Other types of alopecia, including alopecia areata, cicatricial alopecia, or telogen effluvium;
Use of minoxidil, finasteride, spironolactone, or other hair growth-related medications within 1 year prior to screening;
Receipt of platelet-rich plasma (PRP), laser cap therapy, or other scalp procedures within 6 months prior to screening;
History of autoimmune disease, active scalp infection, coagulation disorders, or malignancy;
Known hypersensitivity to the investigational product or any of its components;
Inability to comply with study procedures, incomplete clinical data, or conditions that may interfere with efficacy evaluation;
Participation in another clinical trial within the study period;
Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.

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Interventions

DRUGHuman Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes

Sterile exosome suspension derived from human umbilical cord mesenchymal stem cells (hUCMSC-Exos). Administered via intradermal scalp injection at 0.05 mL per point, 1 cm spacing, approximately 4 mm depth. Treatment repeated once every 4 weeks for a total of 3 sessions.

OTHERNormal Saline (0.9% NaCl)

Sterile 0.9% normal saline injection. Administered via intradermal scalp injection using the same protocol as the experimental group: 0.05 mL per point, 1 cm spacing, approximately 4 mm depth, once every 4 weeks for a total of 3 sessions.