ISRCTN46615946已完成1 期
A prospective phase I/II study to evaluate the use of allogeneic mesenchymal stromal cells for the treatment of skin disease in children with recessive dystrophic epidermolysis bullosa
King's College London (UK)0 个研究点目标入组 10 人开始时间: 2012年8月8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
- 10
研究概览
简要总结
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25905587
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subjects who have a diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) characterised by partial or complete collagen VII deficiency
- •2. Subjects who are = 12 months and = 17 years of age at the time of enrolment
- •3. Subjects whose responsible relative/guardian has voluntary signed and dated an Informed Consent Form (ICF) prior to the first study intervention. Whenever the minor child is able to give consent, the minor's assent will be obtained in addition to the signed consent of the minor's legal guardian
排除标准
- •Current exclusion criteria as of 10/09/2013:
- •1. Subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase
- •2. Subjects who have received immunotherapy including oral corticosteroids for more than 1 week (intranasal and topical preparations are permitted) or chemotherapy within 60 days of enrolment into this study
- •3. Subjects with a known allergy to any of the constituents of the investigational product
- •4. Subjects with signs of active infection
- •5. Subjects with a medical history or evidence of malignancy, including cutaneous squamous cell carcinoma
- •6. Subjects with both positive C7 ELISA and a positive indirect immunofluorescence (IIF) with binding to the base of salt split skin
- •7. Subjects who are pregnant or of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase
- •Previous exclusion criteria:
- •1. Subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase
- •2. Subjects who have received immunotherapy including oral corticosteroids for more than 1 week (intranasal and topical preparations are permitted) or chemotherapy within 60 days of enrolment into this study
- •3. Subjects with a known allergy to any of the constituents of the investigational product
- •4. Subjects with signs of active infection
- •5. Subjects with a medical history or evidence of malignancy, including cutaneous squamous cell carcinoma
- •6. Subjects with positive serum antibodies to C7 confirmed by ELISA
- •7. Subjects who are pregnant or of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase
研究者
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