Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS) patients.
详细描述
The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 20 patients with MS.
The primary objective of the trial is freedom from treatment associated adverse events at 4,12 and 52 weeks post treatment. Secondary objective will be efficacy as assessed at baseline, week 12 and 52 and will be quantified based on the following: Neurological assessment of the MS functional composite assessment which comprises of Expanded Disability Status Scale (EDSS), the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time. Short-form 36 (SF-36) quality of life questionnaire and gadolinium enhanced MRI scans of the brain and cervical spinal cord will also be performed at the indicated time points.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to sign informed consent and capable of understanding the features of this clinical trial.
- •Willing to keep a weekly diary and undergo observation for 12 months
- •Non-pregnant patients 18-55 years of age with MS according to the revised McDonald criteria and meeting the Poser criteria for clinically defined MS.
- •EDSS scores of 2·0 to 5·5 points assessed at least 3 months after the last acute attack of MS.
- •Must have proof of health insurance in country of residence.
排除标准
- •Patients with evidence of active proliferative retinopathy.
- •Patients with poorly controlled diabetes mellitus (glycated hemoglobin: HbA1C > 8.5%).
- •Patients with renal insufficiency (Creatinine> 2.5) or failure.
- •Infection as evidenced by white blood cell (WBC) count of >15,000 k/cumm and/or temperature > 38 Celsius.
- •History of organ transplant.
- •History of previous or active malignancy, except for localised cutaneous basal or squamous cell carcinoma or carcinoma in situ of the cervix
- •Exercise limiting angina ( Canadian Cardiovascular Society Class 3
- •Congestive heart failure (New York Heart Association class 3
- •Unstable angina
- •Acute ST elevation myocardial infarction (MI) within 1month
- •Transient ischemic heart attack or stroke within 1 month
- •Severe valvular heart disease
结局指标
主要结局
Number of participants with adverse events
时间窗: 12 months
次要结局
- Number of participants with a change in quality of life as measured by the Short form 36 (SF-36) quality of life questionnaire(12 months)
- Number of participants experiencing pulmonary edema as measured by 12-lead electrocardiogram (ECG)(1 month, 3 months)
- Number of participants with a change in disability as measured by Expanded Disability Status Scale (EDSS)(12 months)
- Number of participants with a change in brain or spinal cord lesions as measured by gadolinium-enhanced magnetic resonance imaging (MRI)(12 months)
- Number of participants with a change in cognitive function as measured by the • Paced Auditory Serial Addition Test (PASAT)(12 months)
- Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test(12 months)
- Number of participants with a change in mobility and leg function as measured by the 25 foot walking test(12 months)
- Number of participants with a change in neurological impairment as measured by Scripps Neurological Rating Scale(12 months)