EUCTR2011-001393-26-ES进行中（未招募）不适用
Phase II clinical trial to evaluate the feasibility and safety of human adipose derived mesenchymal stem cells on chronic ischaemic stroke. - Celictus study
Fundación para la Investigación Biomédica del Hospital Clínico San Carlos0 个研究点开始时间: 2012年3月29日最近更新:
相关药物
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. Capacity for sign and understand the informed consent form
- •2. Age between 25 and 70 years old in the inclusion time
- •3. Man or woman with middle cerebral artery ischemic stroke at least in the 6 months prior to the inclusion
- •4. Image techniques showing injuries consistent with complete infarction of middle cerebral artery
- •5. Patients with severe secuelae verified by a 2 Rankin test level or less
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Patients requiring tracheostomy or non-invasive ventilation for more than 16 hours a day.
- •2. Presence of multiple lacunar infarcts in CT scan or MRI
- •3. History of intracranial hemorrhage or subarachnoid hemorrhage.
- •4. Patients who have used antipsychotics at therapeutic doses in the month prior to inclusion.
- •5. History of cancer in the three years prior to inclusion.
- •6. Previous ideas of suicide
- •7. Patients with known history of alcohol or drugs.
- •8. Patients with a history of heart disease, renal, hepatic, systemic, immune, that can influence patient survival during the test control.
- •9. Patients with chronic neurological disease like Parkinson's, tremor, neurodegenerative disease, etc. ..
- •10. History of uncontrolled hypertension.
- •11. Pregnant or breast-feeding.
- •12. Potentially fertile women (no hysterectomy without bilateral ovariectomy or post-menopausal for 12 months) that were not committed to use a medically approved method of contraception while receiving study medication and until the completion of the trial.
- •13. Patients with planned surgery from any cause.
- •14. Participating in another clinical trial.
- •15. Patients with immunotherapy.
- •16. Patients in a mode of institutionalization on brain injury center.
- •17. Patient location difficult or not possible.
- •18. Inability to cooperate with the rehabilitation treatment
- •19. Any other reason deemed by the researcher can influence the patient or clinical trial for their participation of it.
- •20. Existence of marked cerebral atrophy on brain MRI
- •21. Patients with acute or chronic active infection including patients with hepatitis B, hepatitis C and HIV.
研究者
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