Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes

    Drug

    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.

  • Normal Saline (0.9% NaCl)

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: hUCMSC-Exosome InjectionExperimental treatment 1 intervention
Group B: Normal Saline InjectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hair Density From Baseline to Week 24

Hair density (hairs/cm²) within a predefined target scalp area will be assessed using digital trichoscopy.

Time frame
Baseline to Week 24
2

Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 24

Global scalp photographs will be evaluated by blinded investigators using the Modified Global Photographic Assessment (MGPA) scale to assess overall improvement in hair growth.

Time frame
Baseline to Week 24

Secondary outcomes

1

Change in Hair Density From Baseline to Week 12

Hair density changes within the predefined target area measured by digital trichoscopy.

Time frame
Baseline to Week 12
2

Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 12

Assessment of global hair growth improvement using standardized photography and MGPA scoring.

Time frame
Baseline to Week 12
3

Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 24

Evaluation of treatment-related quality of life improvement using the Dermatology Life Quality Index questionnaire.

Time frame
Baseline to Week 24
4

Change in Mean Hair Shaft Diameter From Baseline to Week 24

Mean hair shaft diameter will be measured using digital trichoscopic analysis.

Time frame
Baseline to Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhang Han

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now