The Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Isolation and Expansion of Mesenchymal Stem Cells
研究概览
简要总结
This study aims at expanding Umbilical Cord derived Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice and study its efficacy when compared to a Supervised Physical Therapy Program alone.
详细描述
Umbilical cord derived MSCs bank will be generated and all patients given the same cells from the same biological sample.
Thorough clinical, cognitive and motor analysis will be performed at baseline and compared to outcomes at 3 different time points of all enrolled patients.
The study will consist of three arms: 1- Stem cells treatment 2- Stem cells and supervised physical therapy 3- Supervised physical therapy
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
- Single (Investigator)
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
- •A clinical diagnosis of definite MS according to the revised McDonald Criteria.
- •Expanded Disability Status Scale (EDSS) ≤ 7
- •Failure of standard medical therapy
- •Disease duration of at least three years prior to enrollment.
排除标准
- •Pregnant and lactating women
- •Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
- •Recent MS relapse in the month prior to enrollment
- •Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
- •Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
- •Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
- •Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
- •Positive serology for HIV, Hepatitis B or Hepatitis C
- •Any history of malignancy or exposure to radiation at any time prior to enrollment
- •Any contra-indication to lumbar puncture
- •Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.
研究组 & 干预措施
Injection of Umbilical cord derived UC- MSCs
Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients
干预措施: Umbilical cord derived Mesenchymal Stem Cells (Biological)
injection of UC- MSCs and SPT
Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program
干预措施: Umbilical cord derived Mesenchymal Stem Cells (Biological)
injection of UC- MSCs and SPT
Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program
干预措施: Supervised physical therapy (Other)
Supervised Physical Therapy (SPT)
Supervised physical therapy program without stem cells
干预措施: Supervised physical therapy (Other)
结局指标
主要结局
Isolation and Expansion of Mesenchymal Stem Cells
时间窗: 3-6 months
To isolate stem cells from UC: first, the cord will be cut into small pieces around (4-5cm) and washed with phosphate buffered saline, then the umbilical vein and the two arteries will be removed.These pieces will be placed in culture plate and cultured in UC-MSCs medium consist of; alpha modification of Minimum Essential Medium (α-MEM) supplemented with 10% fetal bovine serum, 1% glutamine, 1% penicillin/streptomycin and 1 μg/mL amphotericin B.After incubation period the undigested tissue will be discarded and nucleated cells will be pelleted by centrifugation at 450xg for 10 minutes. Cell pellet will be re-suspended in UC-MSCs culture medium, cultured in tissue culture flasks and placed in CO2 incubator at 37°C, 5% CO2. Cells will be expanded in multilayer cell factory tissue culture flasks to reach an estimated 108 UC-MSCs that will be frozen in bags of 106 cells for subsequent thawing and administration.
次要结局
- Biological Assessments(3-12 months)
- Measuring Non-motor outcomes to assess treatment efficacy.(3-6 months)
- Safety and Efficacy Assessment Pre and Post Treatment(3-12 months)
- Motor Functions Assessments(3-12 months)
研究者
Fatima Jamali
Head of Neuroscience Research
University of Jordan