An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously Into Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Clinical improvement in disability score compared to baseline
研究概览
简要总结
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes?
详细描述
This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation performed intrathecally and intravenously. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females between Age 18 and 80 years.
- •Duration of disease: >5 years
- •Failure to respond or intolerance to the currently available Multiple Sclerosis (MS) immunomodulatory treatments (ie interferons, Copaxone, immunosuppression): the lack of response to these treatments will be determined/defined by either an increase (deterioration) of at least one degree in the Expanded Disability Status Scale (EDSS) score during the last year or the appearance of at least two major relapses of MS during the same period of time (under treatment) or intolerance to these agents.
- •Up to date on all age and gender appropriate cancer screening per American Cancer Society .
排除标准
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- •Life expectancy < 6 months due to concomitant illnesses.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease. For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Systolic blood pressure (supine) ≤90 mmHg;
- •Resting heart rate > 100 bpm;
- •Active clinical infection.
- •Cerebrovascular accident within 6 months prior to study entry
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Unwilling and/or not able to give written informed consent.
研究组 & 干预措施
Adipose SVF IV Infusion
IV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion
干预措施: Harvesting and Implantation of SVF (Procedure)
结局指标
主要结局
Clinical improvement in disability score compared to baseline
时间窗: 6 months
Number of patients with adverse events
时间窗: up to 6 months
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Clinical improvement in disability score compared to baseline
时间窗: 3 months
次要结局
- Reduced number of relapses or freedom from progression of disease(6 months)
- MS disease activity measured by the number of Gd-enhancing brain MRI lesions(6 months)
- MS disease activity measured by the number of Gd-enhancing brain MRI lesions(3 months)
- Reduced number of relapses or freedom from progression of disease(3 months)