Exosome Therapy for Male Androgenetic Alopecia

ConditionAndrogenetic Alopecia (AGA)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexMale

Age18-55

SponsorZhang Han

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes
Normal Saline (0.9% NaCl)

Treatment groups

120 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Zhang Han

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov