Umbilical cord mesenchymal stem cell exosome treatment for male pattern hair loss in young men
A Randomized Controlled Clinical Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
PHASE1; PHASE2 · Shenzhen People's Hospital · NCT07203599
This trial will test whether injections of umbilical cord mesenchymal stem cell exosomes can regrow hair or slow hair loss in men aged 18–35 with androgenic alopecia compared with topical 5% minoxidil.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Male |
| Sponsor | Shenzhen People's Hospital (other) |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07203599 on ClinicalTrials.gov |
What this trial studies
The study has a Phase I dose-escalation portion to identify a safe and tolerable injection dose of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-sEV) and a Phase II randomized controlled portion comparing the selected dose against topical 5% minoxidil. In Phase I, participants are assigned to one of three dosing groups to determine appropriate injection density per square centimeter of hair loss. Phase II randomizes eligible participants to receive either hUCMSC-sEV injections or the comparator and follows hair growth and safety outcomes over a defined follow-up period. Safety monitoring will include adverse event reporting and clinical exams, while efficacy will be measured by standardized hair counts, photographic assessment, and scalp evaluations.
Who should consider this trial
Good fit: Men aged 18–35 with clinically diagnosed androgenic alopecia (Hamilton‑Norwood III–V) who can consent and meet the trial's health and medication restrictions are ideal candidates.
Not a fit: Patients outside the age range, with other scalp diseases, severe systemic illness, recent use of hair-loss drugs, or contraindicated medications are unlikely to qualify or derive benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could offer a new option to stimulate hair regrowth or slow progression of male pattern hair loss with a biologic regenerative approach.
How similar studies have performed: Preclinical studies and small early-phase clinical reports suggest stem cell-derived exosomes may promote hair growth, but large randomized clinical data are currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shenzhen, Guangdong
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Jianglin Zhang, Ph.D
- Email: zhang.jianglin@szhospital.com
- Phone: +86 13873143466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Androgenic Alopecia, androgenic alopecia, human umbilical cord mesenchymal stem cell exosomes