A Phase 1/2 interventional study of Human umbilical cord mesenchymal stem cell exosomes and Minoxidil 5% Topical Solution in Androgenic Alopecia, sponsored by Shenzhen People's Hospital. Recruiting at 1 site in China. Open to male participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Shenzhen People's Hospital · Phase 1/2, Interventional, and Treatment
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:
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.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's planned enrollment of 59 is above the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Shenzhen People's Hospital is the lead sponsor of 63 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10\^8 particles of hUCMSC-sEV per site.
Drug: Human umbilical cord mesenchymal stem cell exosomes
Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10\^9 particles of hUCMSC-sEV per site.
Drug: Human umbilical cord mesenchymal stem cell exosomes
Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10\^10 particles of hUCMSC-sEV per site.
Drug: Human umbilical cord mesenchymal stem cell exosomes
Participants will receive one injection site for each 1 cm² of hair loss area with the optimal dose of hUCMSC-sEV.
Drug: Human umbilical cord mesenchymal stem cell exosomes
Participants will get 1 mL of minoxidil administered daily to the area of hair loss.
Drug: Minoxidil 5% Topical Solution
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.
Also known as: hUCMSC-sEV
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.
Hair density
Hair density will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Time frame: From the first treatment to 24 weeks.
Hair diameter
Hair diameter will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Time frame: From the first treatment to 24 weeks.
Hair count
Hair count will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Time frame: From the first treatment to 24 weeks.
Plan to share: No
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Shenzhen People's Hospital