Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Magnetic resonance imaging
研究概览
简要总结
The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell transplantation through percutaneous injection in patients with chronic spinal cord injury.
详细描述
This is a pilot, open, phase I study, in a prospective cohort. The study population will consist of 5 patients who had spinal cord injury for at least 6 months, with complete paraplegia.
A practitioner, a neurosurgeon and a nurse will review the medical records of patients to determine the presence / absence of inclusion / exclusion criteria. If the patient is a potential candidate for the study, an interview will be scheduled with the patient to review and confirm his/her eligibility. If the clinical eligibility is confirmed, the patient will undergo psychosocial evaluation to determine the degree of emotional equilibrium and conditions for participation in the study.
Patients will undergo a series of clinical and neurological evaluations and will also be submitted to the following procedures:
- Cell blood count;
- Biochemical analysis (measurement of electrolytes - sodium, potassium, magnesium);
- Renal function tests (urea and creatinine);
- Liver function tests;
- Coagulation profile;
- Metabolic profile (glucose, total cholesterol and fractions);
- Urine summary and culture;
- Serology required for blood transfusion and marrow transplant in Brasil;
- Electrocardiogram;
- Chest X-Ray, X-ray of knees;
- Bone densitometry;
- Urodynamic studies;
- Somatosensory evoked potential;
- Computed tomography of thoracic and lumbar spine;
- MRI of the thoracic and lumbar spine.
Also as part of the preoperative evaluation, the patients will respond to questions from the SF (Short Form) -36 questionnaire (for assessment of quality of life) and the questionnaires for the assessment of neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Closed spinal cord injury at thoracic or thoracolumbar level bellow T8, or open spinal cord injury, at the same level, provided that the mechanism of the lesion is a spinal shock, ischemia or hematoma
- •ASIA class A
- •Signing the written consent
排除标准
- •Anatomical transection of the spinal cord
- •Spinal cord lesion by sharp objects
- •Ongoing infections
- •Terminal, neurodegenerative or primary hematological diseases
- •Osteopathies which determine a higher risc to the bone marrow puncture
- •Coagulopathies
- •Severe hepatic, renal or heart failure
- •Pregnancy or lactation
- •Clinical conditions that hinder the percutaneous injection of the cells such as arthrodesis
- •Use of metallic implants near vascular structures (such as cardiac pacemaker or aortic prosthesis) which won't allow patients to perform MRI
- •Participation in other clinical trial
结局指标
主要结局
Magnetic resonance imaging
时间窗: Six months
After the transplantation of the cells, patients will be followed up by clinical examinations and will perform laboratorial and radiological exams, in order to search for complications of the procedure.
次要结局
- Improvement in urological function(Six months)
- Sensitivity and motor strength on the inferior limbs(Six months)
- Improvements in sensorial mapping and neuropathic pain(Six months)
研究者
Ricardo Ribeiro dos Santos
PhD
Hospital Sao Rafael