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临床试验/EUCTR2012-002553-38-ES
EUCTR2012-002553-38-ES进行中(未招募)不适用

Mesenchymal stem cell based therapy for the treatment of osteogenesis imperfecta - TERCELOI

Itziar Astigarraga Aguirre0 个研究点开始时间: 2013年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.-Patient age: older than 6 months and younger than 12 years old.
  • 2.-Patients with molecular confirmation of mutation in either COL1A1 or COL1A2 genes associated with severe deforming OI (type III).
  • 3.-Patiens with HLA identical (that shared at least 5/6 antigens) siblings willing to donate bone marrow-MSCs.
  • 4.-All patients that fulfil the inclusion criteria regardless of whether or not they are undergoing biphosphonate treatment
  • 5.-Patients whose parents or the legal guardians are willing to sign the consent forms to participate in this clinical trial.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 3
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.-Patient age: older than 12 years old
  • 2.-Patients lacking confirmation of mutation in either COL1A1 or COL1A2 genes associated with severe deforming OI (type III).
  • 3.-Other pathological subtypes of OI.
  • 4.-Patiens lacking of HLA identical (that shared at least 5/6 antigens) siblings willing to donate bone marrow-MSCs.
  • 5.-Immunodeficiencies and any other malignancies
  • 6.-Participation in other clinical trial
  • 7.-Any medical or psychiatric condition that in the researcher?s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial.
  • 8.-Patients whose parents or the legal guardians do not sign the consent forms

研究者

发起方
Itziar Astigarraga Aguirre

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