Exosome therapy for male pattern baldness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2, randomized, double-blind study, adult men with Norwood-Hamilton grade III-V AGA will receive local scalp injections of either human umbilical cord mesenchymal stem cell-derived exosomes or placebo saline. Participants will be followed with hair density and thickness assessments, photography, trichoscopy, and quality-of-life questionnaires to monitor safety and efficacy. The goal is to determine if the exosome treatment can improve hair follicle regeneration beyond placebo. Exclusion criteria include other types of hair loss, recent hair treatments, autoimmune or infectious conditions, and contraindications to injections. The study aims to provide regenerative options beyond current therapies that slow progression.

Why it matters

Who can join: the full rules

Inclusion Criteria

Participants must meet all of the following criteria to be eligible for enrollment:

1. Male subjects aged 18 to 55 years;
2. Diagnosis of androgenetic alopecia classified as Norwood-Hamilton grade III-V;
3. Stable pattern of hair loss for at least 6 months prior to screening;
4. Willingness to refrain from using any other hair loss treatments during the study period and for 6 months after completion of treatment.

Exclusion Criteria

Participants meeting any of the following criteria will be excluded:

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

Where it's running

• No.28 Fuxing Road
  Beijing, China Recruiting

Study contacts

• Study coordinator: Han Zhang
• Email: zhang_han_0112@163.com
• Phone: 18510009269

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.