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Efficacy of autologous dermal sheath cup cell transplantation in male and female pattern hair loss: A Single-Arm, Multi-Center, phase III equivalent clinical study.
Harada, Kazutoshi; Ohyama, Manabu; Niiyama, Shiro; Irisawa, Ryokichi; Mae, Kenichiro; Mori, Miho; Wakimoto, Hiroko; Kinoshita-Ise, Misaki; Fukuyama, Masahiro; Hayakawa, Reina; Takagi, Masaya; Yamazaki, Masako; Miyoshi, Mami; Nishikawa, Saori; Sato, Seiji; Nakazawa, Yosuke; Sugimoto, Takaki; Ogo, Masashi; Tsuboi, Ryoji.
Afiliación
  • Harada K; Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
  • Ohyama M; Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan.
  • Niiyama S; Department of Dermatology, Toho University Ohashi Medical Center, Tokyo, Japan.
  • Irisawa R; Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
  • Mae K; Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
  • Mori M; Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
  • Wakimoto H; Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
  • Kinoshita-Ise M; Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan.
  • Fukuyama M; Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan.
  • Hayakawa R; Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan.
  • Takagi M; Regenerative Medicine Research & Business. Development Department, Yokohama, Japan.
  • Yamazaki M; Regenerative Medicine Research & Business. Development Department, Yokohama, Japan.
  • Miyoshi M; Regenerative Medicine Research & Business. Development Department, Yokohama, Japan.
  • Nishikawa S; Regenerative Medicine Research & Business. Development Department, Yokohama, Japan.
  • Sato S; Regenerative Medicine Research & Business. Development Department, Yokohama, Japan.
  • Nakazawa Y; Regenerative Medicine Research & Business. Development Department, Yokohama, Japan.
  • Sugimoto T; Regenerative Medicine Research & Business. Development Department, Yokohama, Japan.
  • Ogo M; Regenerative Medicine Research & Business. Development Department, Yokohama, Japan.
  • Tsuboi R; Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
J Dermatol ; 50(12): 1539-1549, 2023 Dec.
Article en En | MEDLINE | ID: mdl-37752738
A previous, proof-of-concept clinical study suggested that dermal sheath cup cell injections into the affected areas of male/female pattern hair loss (PHL) may have some amelioratory effects, the clinical efficacy of which needs further examination. A phase III equivalent clinical study was conducted to further probe the therapeutic potential of this novel approach and verify its safety and efficacy in improving the appearance of PHL. Thirty-six participants with PHL were injected with dermal sheath cup cell harvested from non-affected occipital hair follicles twice in quarterly intervals. Global photographic assessment and phototrichogram were performed in a blinded manner. Patient-reported outcomes were assessed for 12 months. On global photographic assessment, 30% of the participants showed improvement. The analysis of phototricogram data detected the increases in the cumulative hair diameter, hair cross-sectional area, and mean hair diameter of 107.6 ± 152.6 µm/cm2 , 13069.1 ± 10960.7 µm2 /cm2 , and 0.9 ± 0.9 µm (ratios vs. baseline: +1.4%, +3.4%, and +2.2%), respectively. The female and high terminal hair ratio groups achieved better improvement. Of the total participants, 62.9% noted some degree of improvement. No serious adverse events were detected. This novel approach exhibited visible effects while ensuring safety and patient satisfaction. Therefore, it holds promise as a possible therapeutic option for treating PHL, especially in women.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Alopecia / Cabello Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Female / Humans / Male Idioma: En Revista: J Dermatol Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido
Texto completo
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Imprimir
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Alopecia / Cabello Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Female / Humans / Male Idioma: En Revista: J Dermatol Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido