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

Condition(s) studied

Investigational drug(s) / intervention(s)

Human umbilical cord mesenchymal stem cell exosomes: 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.

Minoxidil 5% Topical Solution: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Hair density — From the first treatment to 24 weeks.
  Hair density will be measured by dermoscopy at weeks 0, 8, 12 and 24.
• Hair diameter — From the first treatment to 24 weeks.
  Hair diameter will be measured by dermoscopy at weeks 0, 8, 12 and 24.
• Hair count — From the first treatment to 24 weeks.
  Hair count will be measured by dermoscopy at weeks 0, 8, 12 and 24.

Trial sites (1)

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