Safety and Efficacy of Autologous Neural Stem Cell Transplantation in Patients With Traumatic Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility and safety of autologous Neural Stem Cell transplantation in patients with complete traumatic spinal cord injury as measured by reported side effects and surgery procedure
研究概览
简要总结
This research investigates the use of autologous neural stem cells in patients with complete traumatic spinal cord injury.
详细描述
The aim of this study is to evaluate Mesenchymal Stem Cells [MSC]-derived autologous neural stem cells transplantation as a safe and potentially beneficial treatment for patients with traumatic spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years old
- •Traumatic spinal cord injury at the neck, thoracic or lumbar level
- •Classification ASIA A and B with no significant further improvement with physical therapy/rehabilitation
- •A score of less than 200 in the 324-point ASIA scale
- •Injury duration 1 month to 5 years
排除标准
- •An advanced, severe, or unstable disease of any type that may interfere with primary and secondary variable evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk (e.g., severe liver or kidney disease, malignancies/cancer)
- •Immune system disorder or dysfunction
- •Any major/serious infections up to 2 months prior to inclusion
- •A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty)
- •A current diagnosis of active, uncontrolled peptic ulceration within the last three months
- •A current diagnosis of acute, severe, or unstable asthmatic conditions [e.g., severe chronic obstructive pulmonary disease (COPD)]
- •Participated in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
- •History of regular alcohol intake or drug abuse in the previous 3 months and not able to sustain from alcohol intake during the trial Cardiovascular
- •A current diagnosis of severe or unstable cardiovascular disease
- •A current diagnosis of sick-sinus syndrome or conduction deficits (e.g., sino-atrial block, second or third degree atrio-ventricular block)
- •A current diagnosis of uncontrolled atrial fibrillation (>100 bpm)
- •A current diagnosis of moderate to severe heart failure [New York Heart Association (NYHA), Class III or more]
- •A myocardial infarction (MI) known to have occurred within the last 3 months
- •A current diagnosis of severe or unstable angina
- •Vital signs (supine) outside the following ranges
- •Systolic blood pressure below 90 or above 160 mmHg
- •Diastolic blood pressure below 55 or above 95 mmHg
- •Radial pulse below 50 or above 100 bpm CNS related
- •A recent history of up to one year or currently diagnosed with cerebrovascular disease (e.g., stroke transient ischemic attacks, aneurysms)
- •A current diagnosis of any primary neuro-degenerative disorder [e.g., Huntington's disease, Parkinson's disease etc.]
- •A current diagnosis of an active, uncontrolled seizure disorder Psychiatric
- •A current DSM-IV diagnosis of major depression
- •Any other DSM-IV Axis 1 diagnosis that may interfere with the response of the patient to study medication, including other primary degenerative dementia, schizophrenia, or bipolar disorder Laboratory abnormalities
- •Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis) Concomitant therapy
- •Previous stem cell treatment
- •Ingested any of the following substances
- •An investigational drug during the past 6 months
- •A drug or treatment known to cause effect on the central nervous system [CNS] during the past four weeks
- •A drug or treatment known to cause major organ system toxicity during the past four weeks
- •Anticholinergic drugs at baseline
- •Medication for Parkinson's disease at baseline (e.g., selegiline, levodopa, amantadine, dopamine agonists, COMT inhibitors)
研究组 & 干预措施
Paraplegics Acute
Acute [1-6 mo.] patients (paraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
干预措施: Autologous Stem Cell Transplantation (Biological)
Paraplegics Sub-chronic
Sub-chronic [6-12 mo.] patients (paraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
干预措施: Autologous Stem Cell Transplantation (Biological)
Paraplegics Chronic
Chronic [1- 5 years]) patients (paraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed.
Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
干预措施: Autologous Stem Cell Transplantation (Biological)
Tetraplegics Acute
Acute [1-6 mo.] patients (tetraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
干预措施: Autologous Stem Cell Transplantation (Biological)
Tetraplegics Sub-chronic
sub-chronic [6-12 mo.] patients (tetraplegics) with complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed.
Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
干预措施: Autologous Stem Cell Transplantation (Biological)
Tetraplegics Chronic
Chronic [1- 5 years]) patients (tetraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells Intervention: Autologous Stem Cell Transplantation & Biomatrix
干预措施: Autologous Stem Cell Transplantation (Biological)
结局指标
主要结局
Feasibility and safety of autologous Neural Stem Cell transplantation in patients with complete traumatic spinal cord injury as measured by reported side effects and surgery procedure
时间窗: 24 months
Side effects is recorded by the hospital staff, in the CRF and by the patient. Surgery procedure is documented by video and standard recording
次要结局
- MRI Scan of Spinal Cord(3, 6,12, 24 months and 3 year follow-up)
- 324-point ASIA and other scoring incl. muscle control and voluntary movement and improvement of sphincters control(3, 6,12, 24 months and 3 year follow-up)