Randomized Clinical Trial for the Evaluation of Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury
研究概览
简要总结
The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete spinal cord injury.
详细描述
This is a randomized, non-placebo controlled, prospective, phase II clinical trial. The study population will consist of 40 patients who had spinal cord injury for at least 12 months, with thoracolumbar chronic and complete spinal cord injury, ASIA grade A.
A practitioner, a surgeon and a nurse will review the medical records of the 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 to review and confirm his/her eligibility. Patients will undergo a series of clinical and neurological assessments 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 Brazil;
- Electrocardiogram;
- Chest X-Ray;
- Bone densitometry;
- Urodynamic studies;
- Somatosensory evoked potential;
- Computed tomography of thoracic and lumbar spine;
- Magnetic resonance imaging 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. Clinical follow-up will be kept for patients who suspend their participation in the study for any adverse event and / or laboratory abnormality, or for the patient's own desire, following insurance protocols. In addition to the clinical and surgical follow-up, specific medical care will be offered to patients who experience adverse events, until stabilization of the patient, even if the target date for completion of the study has been exceeded. The candidates included in the study will be asked to voluntarily participate and give their informed written consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Blunt spinal cord injury at thoracolumbar level, between T1 and L2, or penetrating spinal cord injury, at the same level, provided that the mechanism of injury had been spinal shock, ischemia or hematoma, with at least 12 months of injury;
- •ASIA grade A;
- •Signing of the written consent.
排除标准
- •Spinal cord injuries by sharp objects, firearms, and not traumatic or congenital causes, even if at different levels of the spinal cord;
- •Concomitant brain injuries;
- •Diabetes mellitus type 1 or 2 as defined by fasting glucose above 126 mg / use of medication and medical history;
- •Infectious processes in acute and / or chronic course, confirmed by additional tests and / or medical history;
- •Immunodeficiency, autoimmune diseases and neoplastic processes, confirmed by additional tests and / or medical history;
- •Terminal, neurodegenerative, primary hematologic and musculoskeletal diseases confirmed by additional tests and / or past medical history;
- •Osteopathies reflecting increased risk for bone marrow puncture;
- •Coagulopathies;
- •Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history;
- •Pregnancy or lactation;
- •Clinical complications that hinder or contraindicate the surgical procedure;
- •Use of metallic implants near vascular structures (such as cardiac pacemaker), or other contraindication to magnetic resonance imaging;
- •Psychiatric disorders, psychosocial and cognitive impairment confirmed by medical evaluation;
- •Abusive use of alcohol and / or illegal substances use;
- •Participation in other clinical trial.
研究组 & 干预措施
Treated group
Twenty subjects will be randomly assigned to receive two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
干预措施: Autologous mesenchymal cells transplantation (Biological)
Control group
Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention.
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury
时间窗: 12 months
次要结局
- Functional improvement in ASIA (American Spinal Injury Association) grade(12 months)
- Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)(12 months)
- Improvements in sensorial mapping and neuropathic pain(12 months)
研究者
Ricardo Ribeiro dos Santos
PhD
Hospital Sao Rafael