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临床试验/EUCTR2011-004801-25-ES
EUCTR2011-004801-25-ES进行中(未招募)不适用

A PHASE I/II CLINICAL TRIAL OF THE BONE MARROW'S AUTOLOGOUS STEM CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS

Fundación Sanitaria para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO)0 个研究点开始时间: 2013年1月11日最近更新:

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

  • - Aged between 18 and 70 years.
  • - Diagnosis of definite or probable ALS according to the criteria
  • established by the World Federation of Neurology.
  • - Patient providing sufficient guarantees of adherence to protocol.
  • - Neurophysiological data confirming lower motor neuron involvement of lumbar level.
  • - No motor deficit in dorsiflexion of both feet (4 + or 5 points on the MRC)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 15
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • - Diabetes Mellitus.
  • - Other diseases that may occur with polyneuropathy.
  • - A previous history of stroke.
  • - A previous pathology of peripheral nervous system that affects one or both lower limbs with or without clinically evident neurologic sequelae.
  • - Patients who are pregnant or breastfeeding active
  • - Patients physiologically capable of becoming pregnant, unless they are using reliable contraception (Annex III)
  • - Patients with heart, kidney, liver, systemic immune that may influence patient survival during the test.
  • - Positive serology for hepatitis B, hepatitis C or HIV.
  • - Clinical criteria and anesthesia sedation contraindicating either itself or extraction MO (Altered coagulation system or anticoagulated patient inability to withdraw anticoagulation, hemodynamic instability, altered skin puncture area, etc.)
  • - Included in other clinical trials in the last 6 months.
  • - Inability to understand informed consent.

研究者

发起方
Fundación Sanitaria para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO)

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