Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI
Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in Patients Suffering Incomplete Spinal Cord Injury (SCI)
The study goes on 24 months, with recruiting, treatment and follow period for all patients. The first day for each patient will be the first cellular administration. 3 doses will be administrated every 3 months from first dose.
When the clinical trial finishes, it will be done a completed check of all obtained parameters.
研究概览
详细说明
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) .10 patients will be included with this injury.
Primary objective: Analyze the possible clinical efficacy of administration of main adult mesenchymal autologous cells expanded "in vitro" in patients with incomplete and chronically established SCI.
Secondary objectives: Confirm the safety of treatment, and study possible changes in the cerebrospinal fluid (CSF) levels (Brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), ciliary neurotrophic factor (CNTF), Nerve Growth Factor 3 and 4(NT3 and NT4) after subarachnoid administration of BMMC.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Madrid
-
Majadahonda、Madrid、西班牙、28222
- Hospital Puerta de Hierro
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Incomplete SCI
- Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI.
- Neurophysiological confirmation of incomplete SCI.
- The MRI study that morphologically evaluate the SCI.
- Age between 18 and 70 years
- Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration.
- Ability to attend clinical follow-up and perform physical therapy through the treatment period.
- Written and signed informed consent, according to the local regulation.
- Hematologic and creatinin parameters, SGOT and SGPT, within the normal range, according to laboratory standards considering that small variations could be accepted based on clinical study team criteria.
Exclusion Criteria:
- A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.
- Neurophysiological records that confirm the complete SCI.
- Age below 18 years or above 70.
- Pregnancy or lactation.
- Malignancy disease diagnosed or treated within the last 5 years.
- Patients with systemic disease that represents and additional risk to treatment.
- Patients with uncertain commitment to follow the physical therapy and clinical visits as well as patient with a negative input in the previous phycological assessment.
- Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause.
- Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation.
- Neurodegenerative disease additional.
- History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion.
- Positive serology for HIV and syphilis.
- Active Hepatitis B or Hepatitis C.
- With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Autologous Mesenchymal Bone Marrow Cell
All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell
|
Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Efficacy-Sensivity Improvement Using the ASIA Score
大体时间：measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
|
Sensitivity improvement was measured using the ASIA (American Spinal Injury Association) scale to measure the Surface sensitivity (LTS), pain sensitivity (PPS), and the degree of motor function in key muscles (MS).
The sum of MS, LTS, and PPS configure total ASIA score.
A minimum possible score is 0 points.
A maximum possible score is 224 points for a patient with normal sensation.
ASIA score was obtained before surgery, and 3, 6, 9 and 12 months after surgery.
Mean and standard deviation for the 10 patients were obtained at all the time points and statistically analyzed.
|
measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
|
|
Efficacy- Changes in Functional Independence Measure Scale
大体时间：measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
- Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment. Ranges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence. |
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
|
Efficacy-Change in Barthel Score
大体时间：measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
- Changes in Barthel score at the beginning, through and the end of the treatment. Ranges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence. |
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
|
Efficacy-IANC-SCIFRS Scale
大体时间：Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
|
-Changes in IANC-SCIFRS scale Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value. |
Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
|
|
Efficacy-Changes in PENN Score.
大体时间：measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
- Changes in PENN score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour. |
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
|
Changes in ASHWORTH Score
大体时间：measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
- Changes in ASHWORTH score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension |
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
|
Efficacy-Changes in EVA Score
大体时间：measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
• Changes in EVA score at the beginning, through and the end of the treatment Ranges score: 0 to 10. Being 0 absence of pain and 10 the worst pain. |
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
|
Efficacy- Changes in Geffner Score
大体时间：Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
|
changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder |
Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
|
|
Efficacy- Changes in NBD Score
大体时间：measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction. |
measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
|
|
Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)
大体时间：Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
|
Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.
|
Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
|
|
Efficacy-Urodynammic in Terms of Detrusor Pressure
大体时间：Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
|
Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)
|
Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
|
|
Efficacy-Urodynamic Studies Bladder Compliance
大体时间：measure before treatment (baseline visit), 6 and 12 months after surgery
|
Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling . It gives an indication on how the different mechanisms in the bladder wall react on stretching. It is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality. |
measure before treatment (baseline visit), 6 and 12 months after surgery
|
|
Efficacy-Urodynamic Studies Maximum Cystometric Capacity
大体时间：Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
|
Urodynamic studies in terms of Maximum cystometric capacity
|
Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
|
|
Efficacy-modification of Magnetic Resonance Imaging (MRI)
大体时间：before (baseline visit) and at 12 months
|
Number of patients with changes in morphology of injury compared with basal images
|
before (baseline visit) and at 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Adverse Events .
大体时间：Up to 12 months
|
- The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI).
|
Up to 12 months
|
|
Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples
大体时间：Basal and 10 months after the administration
|
Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time.
The mean+SD (standard deviation) at each time point was obtained.
The tested neurotrophins were: BDNF.
|
Basal and 10 months after the administration
|
合作者和调查者
调查人员
- 首席研究员：Jesús JV Vaquero Crespo, M.D.、Hospital Universitario Puerta de Hierro-Majadahonda
出版物和有用的链接
一般刊物
- Vaquero J, Zurita M. Functional recovery after severe CNS trauma: current perspectives for cell therapy with bone marrow stromal cells. Prog Neurobiol. 2011 Mar;93(3):341-9. doi: 10.1016/j.pneurobio.2010.12.002. Epub 2010 Dec 14.
- Otero L, Zurita M, Bonilla C, Aguayo C, Vela A, Rico MA, Vaquero J. Late transplantation of allogeneic bone marrow stromal cells improves neurologic deficits subsequent to intracerebral hemorrhage. Cytotherapy. 2011 May;13(5):562-71. doi: 10.3109/14653249.2010.544720. Epub 2011 Jan 5.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CME-LEM2
- 2011-005684-24 (注册表标识符：2011-005684-24)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.