Autologous cell-based therapy for male and female pattern hair loss using dermal sheath cup cells: A randomized placebo-controlled double-blinded dose-finding clinical study

Autologous cell-based therapy for male and female pattern hair loss using dermal sheath cup cells: A randomized placebo-controlled double-blinded dose-finding clinical study
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DOI:
10.1016/j.jaad.2020.02.033
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发表时间:
2020-07-01
影响因子:
13.8
通讯作者:
Kishimoto, Jiro
Kishimoto, Jiro
中科院分区:
医学1区
文献类型:
--
作者:
Tsuboi, Ryoji;Niiyama, Shiro;Kishimoto, Jiro

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背景:目前对于男性型脱发(MPHL),尤其是女性型脱发(FPHL),几乎没有有效的治疗方法。近年来,基于自体或异体细胞的细胞疗法已被应用于临床。目的:探讨真皮鞘杯细胞(DSC)自体细胞为基础治疗MPHL和FPHL的安全性和有效性。方法:从枕骨毛囊中提取DSC,培养DSC细胞。患有MPHL或FPHL的参与者在头皮上4个随机分离的区域接受7.5 × 10(6)、1.5 × 10(6)或3.0 × 10(5) DSC细胞或安慰剂的单次注射,并在3、6、9和12个月内测量头发密度和直径。结果:男性50例,女性15例,年龄33 ~ 64岁。6个月和9个月后,与安慰剂相比,3.0 x 10(5) DSC细胞注射部位的总毛密度和累积毛直径显著增加。男性和女性表现出相似的改善,并且没有严重的不良事件。限制:未检测到较低的细胞数,阳性效果是暂时的,直到9个月。结论:自体DSC细胞的细胞治疗可能是治疗MPHL和FPHL的一种新方法。
Background: Few effective treatments are available for male pattern hair loss (MPHL) or, especially, for female pattern hair loss (FPHL). Recently, cell-based therapies using autologous or allogeneic cells have been used clinically.Objective: We examined the safety and efficacy of autologous cellebased therapy using dermal sheath cup (DSC) cells to treat MPHL and FPHL.Methods: DSCs dissected from occipital hair follicles were cultured to manufacture DSC cells. Participants with MPHL or FPHL received single injections of 7.5 x 10(6), 1.5 x 10(6), or 3.0 x 10(5) DSC cells or a placebo in 4 randomized separate regions on the scalp, and hair densities and diameters were measured for 3, 6, 9, and 12 months.Results: Fifty men and 15 women aged 33 to 64 years were injected with DSC cells. Total hair density and cumulative hair diameter at the 3.0 x 10(5) DSC cells injection site was significantly increased compared with the placebo after 6 and 9 months. Men and women showed similar improvements, and there were no serious adverse events.Limitations: No lower cell numbers were tested, and the positive effect was temporary until 9 months.Conclusion: The results suggest that cell therapy with autologous DSC cells may be useful as a new therapeutic method for treating MPHL and FPHL.