A randomized, double-blind, vehicle-controlled clinical study of hair regeneration using adipose-derived stem cell constituent extract in androgenetic alopecia

Young Jin Tak, Sang Yeoup Lee, A Ra Cho, Young Sil Kim, Young Jin Tak, Sang Yeoup Lee, A Ra Cho, Young Sil Kim

Abstract

Accumulating evidence suggests that adipose-derived stem cell constituent extract (ADSC-CE) helps hair regrowth in patients with androgenetic alopecia (AGA). However, the effects 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 fingers, 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 differences in the change of hair count remained significant until week 16 with overall changes of 28.1% vs 7.1%, respectively. Similarly, a significant 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 findings 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.

Keywords: adipose-derived stem cell; androgenetic alopecia; hair growth; hair loss; hair regeneration; mesenchymal stem cell.

Conflict of interest statement

The authors declared no potential conflicts of interest.

© 2020 The Authors. STEM CELLS TRANSLATIONAL MEDICINE published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

Figures

FIGURE 1
FIGURE 1
Example of global photographs taken using a phototrichogram at baseline (A), 8 weeks (B), and 16 weeks (C) after ADSC‐CE application in the ADSC‐CE group (left) and the placebo group (right). ADSC‐CE, adipose‐derived stem cell constituent extract
FIGURE 2
FIGURE 2
Flow diagram of the study process. Of the 44 enrolled candidates, 38 participants were randomized in a 1:1 ratio to receive adipose‐derived stem cell constituent extract or vehicle solution
FIGURE 3
FIGURE 3
Percentage change from baseline in hair count (A) and diameter (B) over 16 weeks (intention‐to‐treat analysis). Data are means ± SD (Control group n = 19, ADSC‐CE group n = 19). *P = .002, **P = .008, ***P = .026. ADSC‐CE, adipose‐derived stem cell constituent extract

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