A randomized, double‐blind, vehicle‐controlled clinical study of hair regeneration using adipose‐der
Abstract
Accumulating evidence suggests that adipose-derived stem cell constituent extract (ADSC-CE) helps hair regrowth in patients with androgenetic alopecia (AGA). However, the e!ects of ADSC-CE have not been demonstrated in a randomized, double-blind, vehicle- controlled clinical trial. In this randomized, double-blind, vehicle-controlled clinical trial, 38 patients (29 men) with AGA were assigned to an intervention group (IG), with twice- daily self-application of the ADSC-CE topical solution over the scalp with #ngers, or to a control group (CG). Changes in hair count and thickness at 16 weeks from the baseline were evaluated using a phototrichogram. Overall, 34 (89%) patients (mean age, 45.3 years) completed the study. The phototrichogram at week 8 showed more increase in hair count in the IG than in the CG, and intergroup di!erences in the change of hair count remained signi#cant until week 16 with overall changes of 28.1% vs 7.1%, respectively. Similarly, a signi#cant improvement in hair diameter was observed in the IG (14.2%) after 16 weeks when compared with hair diameter in the CG (6.3%). Our #ndings suggest that the application of the ADSC-CE topical solution has enormous potential as an alternative therapeutic strategy for hair regrowth in patients with AGA, by increasing both hair density and thickness while maintaining adequate treatment safety.
INTRODUCTION
Androgenetic alopecia (AGA) is the most common type of hair loss and globally a!ects approximately 50% of men and 45% of women by 50 years of age.1 Although it is not a life- threatening condition, hair loss can be a reason for low self-esteem and psychological distress by making the patient look less attractive and older than their actual age.2, 3 However, despite the e!orts of medical experts in seeking e!ective therapeutic agents, only a few Food and Drug Administration (FDA)-approved medications are available for these patients.
Age, genetic predisposition, and androgens are the main known driving factors in AGA progression.1 Dihydrotestosterone (DHT), derived from testosterone, is a major metabolite in hair development.4 DHT stops the growth of the hair follicle cells and shrinks them, leading to hair loss.5 Therefore, 5α-reductase inhibitors that suppress the activity of 5α- reductase, an enzyme that converts testosterone to DHT, have been commonly used in AGA and are regarded the most e!ective medications.6 However, owing to teratogenic risks, 5α- reductase inhibitors are limited to male patients with AGA. Furthermore, they sometimes result in unexpected side e!ects such as decreased libido and ejaculate volume and erectile dysfunction, which greatly a!ects the quality of life in middle-aged men.7 These side e!ects consequently prompt many patients to turn to alternatives with fewer side e!ects.8 Therefore, it is necessary to discover agents with anti-hair loss e!ects and without serious side e!ects to expand the range of treatment in AGA.
Mesenchymal stem cells (MSCs), which are mesoderm-derived immature precursors, have self-renewal potential and multilineage di!erentiation capacity.9 Additionally, as MSCs are found abundantly in the adipose tissue, which is relatively easy to access, recent studies have attempted to identify the medicinal e!ects of MSCs and apply them to regenerative medicine.10, 11 Adipose tissue-derived stem cells (ADSCs) are a type of MSC that secrete several growth hormones that help cells develop and proliferate.9 According to laboratory and experimental studies, growth factors such as hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), and platelet-derived growth factor (PDGF) increase the size of the hair follicle during hair development.11, 12 Recent retrospective human studies have shown that ADSCs promote hair growth in both men and women with alopecia.13, 14
However, no randomized, placebo-controlled trial in humans has explored the e!ects and safety of adipose-derived stem cell constituent extract (ADSC-CE) in AGA. Here, we aimed to assess the e$cacy and tolerability of ADSC-CE in middle-aged patients with AGA. We hypothesized that ADSC-CE is an e!ective and safe agent in the treatment of adults with AGA.
