JPRN-jRCTb041190097已完成1 期
Treatment of epidermolytic ichthyosis using epidermise sheet (Jace) cultured from autologous revertant somatic mosaic site - epidermise sheet cultured from autologous revertant somatic mosaic site
Akiyama Masashi0 个研究点目标入组 3 人开始时间: 2019年12月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
In this study, cultured epidermal sheets prepared from the revertant site of patients who were diagnosed with epidermolytic ichthyosis and had revertant mosaicism were transplanted to the hyperkeratotic lesions. The primary endpoints, "hyperkeratosis improvement rates at 4 weeks after transplantation," in the three subjects were 39.52%, 100.0%, and 100.0%. The secondary endpoints, "hyperkeratosis improvement rates 24 weeks after transplantation" were 0%, 30.37% and 25.30%.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who are diagnosed with epidermolytic ichthyosis and have a revertant somatic mutation, the responsible gene mutation * was identified by genetic testing.
- •* Heterozygote mutation must be demonstrated in either keratin 1 (KRT1) or keratin 10 (KRT10).
排除标准
- •Patients hypersensitive to penicillin, kanamycin, streptomycin, and amphotericin B antibiotics. Patients with a history of hypersensitivity to penicillin antibiotics and aminoglycoside antibiotics.
- •Patients who are allergic to cattle, mice and pigs.
- •Patients with malignant neoplastic lesions other than the skin, or patients with a history within 3 years prior to enrollment.
研究者
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