Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic Syringomyelia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia using the ASIA scale (American Spinal Injury Association
研究概览
简要总结
The objective of the study is to determine if the cell therapy NC1 administered in the spinal cord is effective for the treatment of a post-traumatic syringomyelia. The post-traumatic syringomyelia is the development and progression of cyst filled with cerebrospinal fluid (CSF) within the spinal cord. The cell therapy NC1 consist on cells obtained from the bone marrow of the patient, that are cultured in vitro and administered in the spinal cord of the same patient.
详细描述
Phase II, Open, prospective, not controlled, not randomized clinical trial in patients affected by post-traumatic syringomyelia. The trial evaluates the efficacy of the cell therapy NC1 administered via intrathecal in the location of the injury. After the administration of the cell therapy, patients will undergo physiotherapy during the follow-up period (6 months). Patients will be evaluated at month 3 and month 6 after the NC1 administration.
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
- •Patients with traumatic medullar injury (levels A, B, C or D of the ASIA scale) and associated syringomyelia in at least three spinal segments, and with neurological deficit clinically stable at least 6 months prior to treatment.
- •Previous studies in Neurophysiology, MR, Urology (if data on neurogenic bowel exists), defecatory function (if data on neurogenic intestine exists)
- •Age between 18 and 70 years old.
- •Presence of syringomyelia based on a neuro-image (MR)
- •Patients will compromise to use anticonceptive measures from the cell extraction until 6 months after the administration of the treatment.
- •Patients will compromise to a clinical follow-up and to perform physical therapy, one hour daily five days per week during the treatment period.
- •Patients should sign an written informed consent.
- •Haematological and creatinin parameters, SGOT and SGPT into the normal ranges.
排除标准
- •Patients under 18 or above 70 years old
- •Pregnancy or breastfeeding
- •Neoplasia in the last 5 years
- •Patients with systemic diseases that increase the risk of the surgical intervention
- •Genetics alterations that could conduct to cellular transformation during the cellular expansion phase.
- •Patients not really sure of their cooperation to follow the physical therapy or clinical controls during the study.
- •Additional neurodegenerative diseases
- •Drug consuming, psychiatric disease or allergy to proteins used during cellular expansion
- •HIV or syphilis positive serologies
- •Active Hepatitis B or c, based on serologies
- •Any other reasons according to the investigator criteria.
研究组 & 干预措施
NC 1 cell therapy
All patients will be treated with the same treatment: NC1 cell therapy
干预措施: NC 1 cell therapy (Biological)
结局指标
主要结局
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia using the ASIA scale (American Spinal Injury Association
时间窗: Pretreatment, month 3 post treatment, month 6 post treatment
Neurological evaluation is done using ASIA scale (American Spinal Injury Association)
次要结局
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of spams frequency(Pretreatment, month 3 post treatment, month 6 post treatment)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia assessed with the IANR-SCIFRS scale (Injury Functional Rating Scale)(Pretreatment, month 3 post treatment, month 6 post treatment)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia using the Visual Analog Scale(Pretreatment, month 3 post treatment, month 6 post treatment)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of somatosensory or motor evoked potentials(Pretreatment, month 3 post treatment, month 6 post treatment)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in term of spasticity(Pretreatment, month 3 post treatment, month 6 post treatment)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia by electromyography(Pretreatment, month 3 post treatment, month 6 post treatment)
- Safety, by the assessment of the adverse events of the study(1 year)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia using the Behavior Dimensions Scale(Pretreatment, month 3 post treatment, month 6 post treatment)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia studying the spinal cord morphology(Pretreatment, month 3 post treatment, month 6 post treatment)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of bladder functionality(Pretreatment, month 3 post treatment, month 6 post treatment)
- Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of defecatory function(Pretreatment, month 3 post treatment, month 6 post treatment)
研究者
Jesús Vaquero Crespo, M.D.
M.D.
Puerta de Hierro University Hospital