Evaluating Safety and Effectiveness of Stem Cell-Derived Exosomes Delivered by Microneedles for Male Androgenic Alopecia Treatment

What this Trial Is About

Androgenic Alopecia AGA is a common hereditary hair loss condition with limited current treatments that often cause side effects or have high costs and complications. Researchers are studying human umbilical cord mesenchymal stem cell-derived exosomes hUCMSC-Exos as a new, safer option. These exosomes are tiny, cell-free particles rich in bioactive components, without tumor risks or significant toxicity, making them promising for hair regeneration when combined with advanced delivery methods. This trial compares three groups one using standard topical minoxidil twice daily, another combining minoxidil with traditional exosome lyophilized powder applied after electric microneedling, and a third using minoxidil with an innovative exosome powder prepared by a novel lyophilization method and delivered similarly. The microneedling uses precise, automated needles for uniform scalp penetration, aiming to improve the delivery of exosomes into scalp tissues. Participants will be monitored before treatment and at 4, 12, and 24 weeks after starting. Evaluations include hair density, hair shaft thickness, hair type ratios, photographic scores, physician assessments, patient satisfaction, pain levels, and adverse event monitoring. The study runs from late 2025 until 2027, with visits scheduled to assess treatment effects and safety over this period.

Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia