Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in Patients Suffering Incomplete Spinal Cord Injury (SCI)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Efficacy- Changes in Functional Independence Measure Scale
研究概览
简要总结
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.
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) .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
- •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.
排除标准
- •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
- •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.
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 Cell
干预措施: Adult Autologous Mesenchymal Bone Marrow Cell (Biological)
结局指标
主要结局
Efficacy- Changes in Functional Independence Measure Scale
时间窗: 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.
Efficacy-Change in Barthel Score
时间窗: 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.
Efficacy-Changes in PENN Score.
时间窗: 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.
Changes in ASHWORTH Score
时间窗: 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
Efficacy-Urodynammic in Terms of Detrusor Pressure
时间窗: 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)
Efficacy-modification of Magnetic Resonance Imaging (MRI)
时间窗: before (baseline visit) and at 12 months
Number of patients with changes in morphology of injury compared with basal images
Efficacy-Urodynamic Studies Maximum Cystometric Capacity
时间窗: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
Urodynamic studies in terms of Maximum cystometric capacity
Efficacy-Sensivity Improvement Using the ASIA Score
时间窗: 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.
Efficacy-IANC-SCIFRS Scale
时间窗: 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.
Efficacy-Changes in EVA Score
时间窗: 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.
Efficacy- Changes in Geffner Score
时间窗: 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
Efficacy- Changes in NBD Score
时间窗: 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.
Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)
时间窗: 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-Urodynamic Studies Bladder Compliance
时间窗: 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.
次要结局
- Number of Adverse Events .(Up to 12 months)
- Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples(Basal and 10 months after the administration)
研究者
Jesús Vaquero Crespo, M.D.
Principal Investigator
Puerta de Hierro University Hospital