NL-OMON41470已完成2 期
nrelated cord blood transplantation after reduced toxicity conditioning with mesenchymal stromal cell co-infusion in patients with severe epidermolysis bullosa - CB+MSCforEB
niversitair Medisch Centrum Utrecht0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •(1) Diagnosed genetically & molecularly Epidermolysis Bullosa type recessive dystrofische severe generalized
- •2) having a single matching (* 5/6) umbilical CB unit available with sufficient cell count total NC count > 3 * E7/kg for the 8-10/10 matched units and >5*10e7/kg for the 6-7/10 matched units
- •(3)Lansky,Karnofsky >40
- •(4)Age <18
- •(5) approval of eligibility by international expert panel & UMCU kernteam HCT
- •(6) Signed informed consent
排除标准
- •(1) Creatinine clearance < 40 ml/min
- •(2) Cardiac dysfunction (SF < 30%) (Ejection fraction < 45%), unstable angina, or unstable cardiac arrhythmias
- •(3) Pulmonary function test VC, FEV1 and/ or DCO< 50%
- •(4) Subjects with medical history of evidence of malignancy, including cutaneous squamous cell carcinoma
- •(5) Allergy to any of the known constituents of the investigational product
- •(6) HIV seropositive infection
研究者
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