Phase I Pilot Study to Evaluate the Security of Local Administration of Autologous Stem Cells Obtained From the Bone Marrow Stroma, in Traumatic Injuries of the Spinal Cord
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety-Number of Adverse Events
研究概览
简要总结
The purpose of this study is to confirm the security, and detect the effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells.
详细描述
It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury (SCI) who were treated with autologous stromal cells of the bone marrow administrated locally (subarachnoid and intramedullar) by intrathecal microinjection and three months later, by lumbar subarachnoid administration. The minimum follow-up duration for each patient is 12 months after the first administration, or until death, if it occurs it before.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with ages between 18 years and 60 years with of age or older functional sequelae chronically established by traumatic injury of the spinal cord (spinal segments between the vertebral bodies C6 and L1) and considered irreversible (not respond to any other treatment). In this study, the lesion is considered chronically established, when there are no signs of functional recovery after a minimum follow-up period of 6 months after the spinal cord injury. The upper age limit is justified by the low potential of in vitro expansion of bone marrow stromal cells over 60 years.
- •Complete paraplegia, with loss of motor and sensory function below the lesion (grade A in the American Spinal Injury Association Impairment (ASIA) Scale .
- •Spinal injury MRI morphologically visible, and without images that suggest spinal cord transection, with separation of the both ends of the spinal cord.
- •Tracking evolutionary possibility after treatment protocol and to comply physiotherapy maintained throughout the follow up period.
- •Written informed Consent according to good clinical practice (GCP) and local regulations, obtained before any study procedure.
- •Hematological parameters and creatinine, serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) in normal range according to laboratory standards, are accepted, however, small non-significant deviations according to the investigator.
排除标准
- •Pregnancy and lactation
- •Systemic disease represents an added risk to treatment
- •Patients with questions about their possible cooperation in rehabilitation-physiotherapy treatments later, or negative report psychological assessment prior.
- •Neuroimaging data showing spinal cord section with separation of the terminal portion of the spinal cord
- •Current neoplastic disease diagnosed or treated in the previous five years
- •Patients treated with hematopoietic growth factors or requiring stable anticoagulation
- •Added neurodegenerative disease
- •History of substance abuse, psychiatric illness or allergy to protein products used in the process of cell expansion
- •HIV positive serology and syphilis
- •Hepatitis B or Hepatitis C active According to the investigator's opinion if there are findings on physical examination, abnormal clinical test results or other medica relevant entries, social or psychosocial factors which might influence negatively the study.
研究组 & 干预措施
Mesenchymal stromal cell therapy
Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later
干预措施: Mesenchymal stromal cell therapy (Biological)
结局指标
主要结局
Safety-Number of Adverse Events
时间窗: Up to 12 months
Clinical evaluation of possible adverse effects is performed daily at the first week after the first administration of stem cells and weekly until the 6 months follow-up visit and then at month 9 and 12. . * During the first stem cells administration (during surgery): Changes in vital signs (ECG, Blood Pressure (BP), Heart Rate (HR) were evaluated * During the second stem cells administration: Changes in vital signs (BP, HR), headache and meningeal irritation were evaluated * During the first weeks, after the first and the second administrations, the possibility of meningeal irritation, headache and infectious complications were considerate. MedDRA stardards are followed
次要结局
- Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials)(Changes in the level neurophysiological parameters improvement (baseline visit) and 6, 12 months after surgery (follow-up period))
- Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section)(Changes in the level of Chronic pain before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period))
- Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity(Urodynamic studies before surgery and 12 months after surgery (follow-up period))
- Efficacy-modification of Magnetic Resonance Imaging (MRI)(changes in the spinal cord morphology on neuroimaging studies before surgery and 12 months after surgery (follow-up period))
- Efficacy-Sensitivity Recovery Using ASIA Scale(sensitivity before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period))
研究者
Jesús Vaquero Crespo, M.D.
Doctor on neurosurgery
Puerta de Hierro University Hospital