Clinical Trial Phase I / II Multicenter, Randomized, Crossover, Double-blind Evaluation of the Safety and Feasibility of Systemic Therapy With Mesenchymal Cells Derived From Autologous Bone Marrow in Patients With Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Absence of unexpected serious adverse reactions as a measure of safety and reduction in number and volumes of the lesions on magnetic resonance image
研究概览
简要总结
This is a phase I / II for the evaluation of the safety and feasibility of intravenous infusion of mesenchymal cells from autologous bone marrow in patients with Multiple Sclerosis.
Intravenous administration of autologous mesenchymal cells of bone marrow is feasible and safe and can be effective in treating patients suffering from multiple sclerosis.
详细描述
The study population will consist of a total of 30 patients diagnosed with multiple sclerosis, who meet all inclusion criteria and none of the exclusion set and express their agreement to participate in the study by signing the informed consent of those whose results can be clinically evaluable.
Selected patients who consent will be enrolled in the trial and randomized to one of the following groups:
- Group 1 receiving a single intravenous administration of cellular product on Day 0 and placebo infusion on day + 180.
- Group 2 receiving a placebo infusion on day 0 and a single cell product administration on day +180.
Randomization will be 1:1, so that 15 patients will receive the cellular product on Day 0 (Group 1) and 15 patients on day +180 (group 2), always maintaining at all times the double-blind status of the test (patients and researchers).
The bone marrow will be extract from all patients immediately after inclusion in the study, under local anesthesia with sedation. For patients in group 1 autologous mesenchymal cells will be obtained from the bone marrow and infuse immediately after the time necessary for their production. For patients in group 2, bone marrow cells will be frozen for later procedure of mesenchymal cells and their infusion after six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •1. Patients diagnosed with MS in their inflammatory forms :
- •Course outbreaks ( relapsing- remitting ) , who have not responded to at least one year of treatment with one or more of the approved therapies (beta - interferon, glatiramer acetate, natalizumab , mitoxantrone, fingolimod ) , confirmed by one or more of the following criteria:
- •( ii ) At least one clinically documented outbreak in the past 12 months. ( iii ) At least two clinically documented outbreaks in the last 24 months ( iv ) At least one lesion with gadolinium on MRI performed in the last 12 months.
- •b . Secondary progressive forms that have not responded to at least one year of treatment with one or more of the approved therapies ( interferon beta , glatiramer acetate, natalizumab , mitoxantrone, fingolimod ) . That meet the following criteria:
- •( i ) Increase of 1 point or more if baseline EDSS score is less than or equal to 5.0 , or 0.5 point increase if the baseline score is greater than or equal to 5.5, in the last 12 months.
- •( ii ) at least one clinically documented outbreak or at least one lesion with gadolinium on MRI within the last 12 months.
- •c . Primary progressive forms that meet the following three criteria:
- •( i ) Increase of 1 point or more if baseline EDSS score is less than or equal to 5.0 , or 0.5 point increase if the baseline score is greater than or equal to 5.5, in the last 12 months.
- •( ii ) At least 1 lesion with gadolinium on MRI within the last 12 months. ( iii ) oligoclonal bands in cerebrospinal fluid (CSF) .
- •2 . Normal laboratory parameters , defined by:
- •Leukocytes ≥ 3000
- •Neutrophils ≥ 1500
- •Platelets ≥ 100,000
- •Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 2.5 standard range institution
- •Creatinine ≤ 2.5 mg / dl
- •3 . Patients of both sexes aged between 18 and
- •4 . Disease duration ≥ 2 years and ≤ 10 years.
- •5 . EDSS (Expanded Disability Status Scale) between 3.0 and 6.5 points.
- •6. Patients give their informed consent for participation in the clinical trial consent.
- •7. Women of childbearing potential must have negative results on a pregnancy test at the time of inclusion in the study and agree to use a medically approved method of contraception while on study
排除标准
- •Any active or chronic infection, including Hepatitis B virus (HBV), Hepatitis C virus (HCV) or HIV .
- •Immunosuppressive therapy in the 3 months prior to randomization (including natalizumab and fingolimod ).
- •Treatment with interferon beta or glatiramer acetate in the 30 days prior to randomization .
- •Corticosteroid therapy in the 30 days prior to randomization.
- •Time since last exceeding 60 days prior to randomization outbreak.
- •History of malignancy ( basal cell carcinoma of skin and carcinoma in situ are excluded in remission for over a year).
- •Life expectancy severely limited by other co - morbidities.
- •Previous history of myelodysplasia or hematological disease , or clinically relevant changes currently in the leukocyte count.
- •Pregnancy / risk of pregnancy (including refusal to use contraception)
- •Renal failure (eGFR <60 mL/min/1.37m2)
- •Inability to undergo MRI scans
- •Inability to give written informed consent.
结局指标
主要结局
Absence of unexpected serious adverse reactions as a measure of safety and reduction in number and volumes of the lesions on magnetic resonance image
时间窗: 12 months
次要结局
- Differences the results obtained in the two groups of patients due to determined parameters.(12 months)