Proposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Standard Complication Questionnaire
研究概览
简要总结
The intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) 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 ADSC implantation using an IV delivery system. The study will provide therapies to up to 100 qualified patients who match the inclusion/exclusion criteria, agree to the follow up program and who have provided a signed consent for each procedure.
The treatment is a combination of (a) general detoxification, (b) lymphatic massage/drainage, (c) therapeutic massage, reflexology and acupuncture and (d) cellular infusion therapy in which cells will be deployed via IV injection over two treatments of 60 minutes each during the five (5) day treatment period.
Follow-up data based upon MSIS-29, a modified SF-36 and standard complication questionnaire will be collected at 3, 6 and then annually post treatment by the patients' local physician and reported back to the sponsor where it will be logged into a HIPPA-compliant outcomes database.
Additional safety data, based upon a standard complication questionnaire will be collected via survey of patient at intervals of 3 and 6 months and then annually for a minimum of five (5) years.
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
- •Confirmed Diagnosis of MS
- •Aged 18 - 65 years.
- •Duration of disease: >5 years
- •Signed, written informed consent willing and able to comply with study visits according to protocol for the full study period
- •Physically, mentally and legally capable of international travel for treatment
排除标准
- •Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
- •Patient with any active or chronic infection
- •No life-threatening organ dysfunction.
- •Pregnancy or risk of pregnancy.
- •Severe physical limitations or disabilities
- •Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
- •Patients unable to give written informed consent in accordance with research ethics board guidelines
- •Treatment with any immunosuppressive therapy within the 3 months prior to randomization
- •Current treatment with an investigational therapy
研究组 & 干预措施
Adipose derived mesenchymal cells
Intervention: Autologous adipose derived mesenechymal stem cells, 150 million cells deployed via two (2) treatments via intravenous injection
Other Names:
ADSC, mesenchymal cells, stromal cells
干预措施: Autologous adipose derived mesenchymal cells (Biological)
结局指标
主要结局
Standard Complication Questionnaire
时间窗: 3 months
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
MS Impact Scale - MSIS-29
时间窗: 3 months
Multiple Sclerosis Impact Scale (MSIS-29)
Physical Evaluation
时间窗: 3 Months
Vital signs of sitting blood pressure, temperature and heart rate
Modified SF-36 Cell-Based Therapy Follow Up
时间窗: 3 months
Modified SF-36 for Cell-Based Therapy Follow Up
次要结局
- Standard Complication Questionnaire(5 years)
- MS Impact Scale - MSIS-29(1 year)
- Modified SF-36 Cell-Based Therapy Follow Up(6 months)
- Physical Evaluation(1 Year)
- MS Impact Scale - MSIS-29(6 months)
- Standard Complication Questionnaire(6 months)
- Standard Complication Questionnaire(1 year)
- Standard Complication Questionnaire(2 years)
- Standard Complication Questionnaire(3 years)
- Standard Complication Questionnaire(4 years)
- Physical Evaluation(6 months)