Exosome Therapy for Male Androgenetic Alopecia

Recruiting now · Phase 2

Conditions studied: Androgenetic Alopecia (AGA)

In brief

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

Key facts

Study ID

NCT07693244

Run by

Zhang Han

People needed

120

Starts

2026-04-30

Expected to finish

2026-11-10

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• No.28 Fuxing Road — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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