Intrathecal Administration (Pattern 100/3) of Expanded Autologous Adult Bone Marrow Mesenchymal Stem Cells in Established Chronic Spinal Cord Injuries
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation.
研究概览
简要总结
The purpose of this study is to analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of patients with established chronic spinal cord injury (LEM).
详细描述
This is a clinical trial phase II, single-center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury.
Patients are treated with repeated administrations of in vitro expanded autologous adult bone marrow mesenchymal stem cells.
The expanded cells are administered in the subarachnoid space by lumbar puncture. The minimum duration of the follow-up period for each patient is 10 months after the first administration.
The study duration is 24 months, that include recruiting, treatment and follow period for all patients. For each patient at the first day will be administered the first cellular doses, then 3 doses will be administrated every 3 months. At the end of the clinical trial, a completed check of all obtained parameters will be performed.
It is considered Day 1 for each patient the first day of the first cell administration. The remaining 2 doses will be administered at intervals of 3 months from the first administration (of the treatment period after, months 4 and 7). At the end of the study will be performed a full assessment of the variables collected along the study trial.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury (Level A, B, C or D in ASIA scales), clinically stable for at least 6 months prior to study start.
- •Previous studies of Neurophysiology, MRI and Urology to allow useful baseline, in order that they can be compared with the same scans following treatment, and to obtain objective data of potential efficacy.
- •Age between 18 and 70 years.
- •Men and women of childbearing age must compromise to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the Mesenchymal Stem Cells (MSC) last administration by lumbar puncture.
- •Possibility of follow up and ability to perform ambulatory physical therapy throughout all treatment period.
- •Written informed consent, according to the law in force.
- •Hematologic, creatinine, Serum glutamic oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) parameters, within the normal range, according to laboratory standards. However, slight modifications that are considered significant in the context of treatment to be performed, according to the criterion of the research team, are accepted.
排除标准
- •Age below 18 years or above
- •Pregnancy or lactation.
- •Current neoplastic disease or in the previous 5 years (diagnosed or treated).
- •Patients with systemic disease that represents an added risk to treatment.
- •Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
- •Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study
- •Neurodegenerative disease added.
- •History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion.
- •Positive serology for HIV and syphilis.
- •Active Hepatitis B or Hepatitis C, according to serology analysis.
- •If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.
研究组 & 干预措施
Autologous Mesenchymal Bone Marrow Cell
All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow expanded Stem Cell (CME)
Pharmaceutical form: Suspension in autologous plasma cell Route of administration: Intrathecal in subarachnoid space by lumbar puncture. Dose: Total dose of 300 x 106 CME, given in 3 injections of 100 x 106 CME, at intervals of 3 months between each administration.
干预措施: Autologous Mesenchymal Bone Marrow Cell (Biological)
结局指标
主要结局
Changes in IANR-SCIFRS score are considerate for the motor and sensory functions evaluation.
时间窗: from baseline until the end of the follow up period (24 months)
Efficacy evaluation by measuring the change in motor and sensory functions by using the international Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS). This scale includes 9 categories with 16 items in total (plus one optional category). The maximum possible score is 48; the lowest possible score is 0.
次要结局
- Changes in PENN score are considerate for the motor and sensory functions evaluation(from baseline until the end of the follow up period (24 months))
- Neurotrophic factors levels in Cerebrospinal fluid (CSF) and/ or Number of Adverse Events related to treatment(from baseline to 24 months)
- Changes in GEFFNER score are considerate for the Assessment of the functional status(from baseline until the end of the follow up period (24 months))
- Changes in VAS score are considerate for quantification of pain(from baseline until the end of the follow up period (24 months))
- Changes in BDS score are considerate for the Assessment of the functional status(from baseline until the end of the follow up period (24 months))
研究者
Jesús Vaquero Crespo, M.D.
Principal Investigator
Puerta de Hierro University Hospital