A 3 Months Open Phase I Study to Assess the Safety of the Intrathecal Application of Neuro-Cells in End Stage (Chronic) Traumatic Spinal Cord Injury Patients
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
- Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by blood
研究概览
简要总结
Mono-center, open label study to investigate the safety of Neuro-Cells in 10 end stage (chronic) traumatic spinal cord injury (TSCI) patients, when administered once intrathecally. TSCI is a rare disease without cure perspectives and Neuro-Cells is an autologous fresh stem cells containing product (one batch / one patient).
详细描述
This phase I clinical study is an open clinical trial to investigate the safety of the intrathecal application of Neuro-Cells in the treatment of end stage (chronic), traumatic complete (AIS grade A) and incomplete (AIS grade B/C) SCI patients. To that purpose, after inclusion in this study >1 year and less than 5 years after their SCI-event, 10 patients will be included. All patients are invited to visit the trial hospital every month during this 3-months study for appreciation of their possible (S)AEs and/or SUSARs, for physical examination and a biochemical analysis of their blood/urine. Day 0 and day 90 they also undergo a comprehensive neurological examination, the AISIAms, ASIAss and Pain perception.
Finally, the participants are also invited to undergo neurological examinations at day 360 and 720. The purpose of this neurological assessment is to explore in patients if a late administration of Neuro-Cells may have some beneficial effects on the neurological condition of the chronic SCI patient.
All patients undergo a BM harvesting at the start of their participation in the study and will undergo one LP, performed to administer Neuro-Cells. The study is open and descriptive, and no randomization takes place. All patients are followed up until approximately 3 months after the time of administration. After these 3 months, the safety part of this study ends. Patients are invited for a neurological assessment 9 months later (day 360) to explore if Neuro-Cells may have a beneficial effect when given to end stage patients with a traumatic SCI.
The safety part of the study is completed when the last patient finishes his/her visit at day 90. The explorative part of the study ends approximately one year after the time of inclusion at day 720.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18 - 40 years
- •Complete (AIS grade A) or incomplete (AIS grade B) TSCI (ISNCSCI-assessed) at time of recruitment
- •Level of injury between C5 to T12
- •Voluntary signed informed consent by patients and Investigator before any trial-related procedures are performed
排除标准
- •SCI AIS grade D or E at the start of enrolment
- •Allergic to mice antibodies and/or iron-dextran
- •Level of SCI above C5 or below T12
- •Positive HIV, hepatitis B or C serology
- •Positive Lues test
- •Total Nuclear Cell (TNC) count < 1x109 TNC
- •Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative disorder (e.g. stroke, amyotrophic lateral sclerosis, multiple sclerosis etc), diabetes mellitus type 1, renal or cardiac insufficiency based on anamnesis history and at the investigator's discretion
- •Any concomitant treatment or medication that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (especially methotrexate, cyclosporine, and corticosteroids have to be avoided) known to interact with the anti-inflammatory and immune-modulative actions of stem cells (non-steroid anti-inflammatory drugs (NSAIDs) are allowed)
- •Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g. heroin, cocaine, XTC)
- •Individuals that belong to vulnerable population groups
- •Females with childbearing potential without using adequate birth control methods (e.g. contraceptive pills, intrauterine devices (IUD), contraceptive injections (prolonged-release), subdermal implantation, vaginal ring or transdermal patches), and/or being pregnant or in the lactation period
- •Participation in any clinical trial (with exemption of descriptive studies with questionnaires and no active intervention) within the previous 30 days before enrolment, or simultaneous participation in such trial
- •Patients with extreme comorbidity before or after the TSCI are excluded at discretion of the PI
- •Patients who are unable to comply with the requirements of this clinical trial
研究组 & 干预措施
Neuro-Cell group
Patient receives treatment once at start of study and followed up for safety.
干预措施: Neuro-Cells (Biological)
结局指标
主要结局
Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by blood
时间窗: 3 months
Measuring biochemical blood variables
Characterize and confirm safety of intrathecal administration of Neuro-Cells by ISNCSCI checklist
时间窗: 3 months
checklist in which the physician focusses on the spinal cord
Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by urine
时间窗: 3 months
Measuring biochemical urine variables
Characterize and confirm safety of intrathecal administration of Neuro-Cells by adverse events
时间窗: 3 months
Severity of adverse events (if applicable)
次要结局
- The effect of Neuro-Cells on the daily activity level as measured by the Pain basic data set(24 months)
- The effect of Neuro-Cells on change in pain assessed by the pain basic data set scale.(24 months)
- The effect of late administration of Neuro-Cells by change in American Spinal Injury Association sensory scale score(24 months)
- The effect of Neuro-Cells on pain-reducing medication by looking at change in prescribed medication(24 months)
- The effect of late administration of Neuro-Cells by change in American Spinal Injury Association motor scale score(24 months)
- Investigate the effect of Neuro-Cells on the autonomic neurological dysfunction(24 months)
- The effect of Neuro-Cells on the sensory neurological dysfunction(24 months)