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NCT Number: NCT07203599

A Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes

This clinical trial aims to determine the efficacy of human umbilical cord mesenchymal stem cell exosomes (hUCMSC-sEV) in treating androgenic alopecia in young men. It will also investigate the safety of hUCMSC-sEV. The primary inquiry it seeks to address is:

* Do hUCMSC-sEV demonstrate efficacy in the treatment of androgenic alopecia in young men? * Do hUCMSC-sEV safely used to treat androgenic alopecia in young men?

The clinical trial has two parts. The Phase I study is a dose-escalation trial. Researchers will determine the appropriate dosage of hUCMSC-sEV. The Phase II study is a randomized controlled trial. Researchers will evaluate hUCMSC-sEV against a placebo (minoxidil tincture) to determine the efficacy of hUCMSC-sEV in treating androgenic alopecia in young men.

In the phase I study, participants will be categorized into three dosage groups: A, B, and C. In Group A, one injection site will be allocated for each 1 cm² of hair loss area, delivering a dosage of 1.0×10^8 particles per site. In Group B, the dosage will be 1.0×10^9 particles per site. In Group C, the dosage will be 1.0×10^10 particles per site. Participants will attend the clinic at weeks 0, 2, 4, and 6 for treatment and assessments. Participants will also attend the clinic for follow-up examinations at weeks 8, 12, and 24.

In the phase II study, participants will be randomly allocated in a 1:1 ratio to two groups: the hUCMSC-sEV treatment group and the minoxidil treatment group. hUCMSC-sEV treatment group: the appropriate dose of hUCMSC-sEV for the phase II study was determined based on assessments of safety, tolerability, and preliminary efficacy from the phase I study. Participants will receive one injection site for each 1 cm² of hair loss area. Participants will attend the clinic for therapy and assessments at weeks 0, 2, 4, and 6. Minoxidil treatment group: participants will get 1 mL of minoxidil administered daily to the area of hair loss for 12 consecutive weeks. All patients will attend the clinic for follow-up examinations at weeks 8, 12, and 24.

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Key information

Conditions

Androgenic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location status: Recruiting

Location contact

Zhenjun Deng, Ph.D

CONTACT

[email protected]

+86 18487380167

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Male patients aged 18-35 2. Clinically diagnosed with androgenic alopecia, Hamilton Norwood Scale III-V 3. Patients who voluntarily participate in clinical trials and sign informed consent forms

Exclusion criteria

  • 1. Known alcohol allergy 2. Patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine, or hematopoietic system 3. Patients with other scalp diseases or hair loss diseases 4. Patients with severe mental illness and cognitive impairment 5. Patients with poor nutritional status and low immune function 6. Within 1 year, those who have used systemic corticosteroids, immunosuppressants, cytotoxic drugs, and peripheral vasodilators 7. Within 6 months, those who have used systemic or local drugs to treat hair loss, such as finasteride, minoxidil, etc 8. Within 3 months, those who have received other clinical trial drugs 9. Family genetic history or other criteria considered unsuitable by researchers

Treatment and study plan

Human umbilical cord mesenchymal stem cell exosomes

Drug

Human umbilical cord mesenchymal stem cell exosomes are nanoscale vesicles released by mesenchymal stem cells from the umbilical cord. These exosomes act as natural carriers, transferring proteins, microRNAs (miRNAs), and other molecules to recipient cells. This communication helps the exosomes exert therapeutic effects, promoting tissue repair, reducing inflammation, and mediating cell-to-cell interactions in various disease models.

Other names: hUCMSC-sEV

Minoxidil 5% Topical Solution

Drug

Topical minoxidil is a medicine used to help regrow the hair on your scalp. It works by increasing the blood flow to your hair and helps stimulate your hair follicles to grow.

Primary outcomes

  1. Hair density

    Time frame: From the first treatment to 24 weeks.

    Hair density will be measured by dermoscopy at weeks 0, 8, 12 and 24.

  2. Hair diameter

    Time frame: From the first treatment to 24 weeks.

    Hair diameter will be measured by dermoscopy at weeks 0, 8, 12 and 24.

  3. Hair count

    Time frame: From the first treatment to 24 weeks.

    Hair count will be measured by dermoscopy at weeks 0, 8, 12 and 24.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianglin Zhang, Ph.D

CONTACT

[email protected]

+86 13873143466

Zhenjun Deng, Ph.D

CONTACT

[email protected]

+86 18487380167

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study title

A Randomized Controlled Clinical Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes

Acronym: MSCs treatment

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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