| 专利名称 | DOSAGE UNIT FORMULATIONS OF AUTOLOGOUS DERMAL FIBROBLASTS | ||
| 申请号 | EP11720666 | 申请日 | |
| 公开(公告)号 | EP2566489B1 | 公开(公告)日 | |
| 申请(专利权)人 | Fibrocell Technologies Inc | 发明人 | MASLOWSKI John |
| 专利来源 | 国家知识产权局 | 转化方式 | |
| 摘要 |
Dosage units consist of an autologous cell therapy product composed of fibroblasts grown for each individual to be treated. The suspension of autologous fibroblasts, grown from a biopsy of each individual' s own skin using current good manufacturing practices (CGMP), and standard tissue culture procedures, is supplied in vials containing cryopreserved fibroblasts or precursors thereof, having a purity of at least 98% fibroblasts and a viability of at least 85%, for administration of from one to six mL, preferably two mL, of cells at a concentration of from 1.0-2.0?07 cells/mL. When injected into the nasolabial fold wrinkles (creases on the sides of the nose that extend to the corners of the mouth), the autologous fibroblasts are thought to increase the synthesis of extracellular matrix components, including collagen, reducing the severity of these wrinkles. Dosage and timing of administration have been demonstrated to be critical to achieving clinically significant outcomes. |
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