NCT02490501已完成1 期
An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects With Traumatic Spinal Cord Injury
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- BioArctic AB
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of subjects with an Adverse Event
研究概览
简要总结
This is an open, randomized, rehabilitation-controlled study in subjects with complete Traumatic Spinal Cord Injury, where the active treatment consists of a surgical implantation of SC0806 (a biodegradable device with heparin-activated FGF1 and nerve implants).
详细描述
The study is a single dose study in up to 3 sequences in subjects with complete Traumatic Spinal Cord Injury. In each sequence, 6 subjects will be randomized to a surgical procedure where SC0806 will be implanted into the spinal cord and receive specific walking training, and 3 subjects will be randomized to specific walking training only. Interim analyses of safety parameters will be performed. If a positive effect and no major safety concerns have been demonstrated after completion of all sequences, the control subjects will be given the opportunity to receive treatment with SC0806 after completion of their rehabilitation periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic Spinal Cord Injury.
- •Male or female subjects aged between 18 and 65 years.
- •BMI ≤35, body weight ≤125 kg and height ≤ 195 cm at Screening.
- •Complete SCI (ASIA Impairment Scale level A, no voluntary bladder function, negative motor and sensory evoked potentials).
- •A single spinal cord lesion injury at the neurologic level between T2-T
- •A Baseline MRI that indicates a pathology consistent with a traumatic SCI
- •Minimum of 4 months and maximum 10 years post injury with no evidence of neurological improvement prior to implantation surgery unless there is a complete anatomical cut-off of the spinal cord.
- •Females must not be lactating or pregnant at Screening and Baseline (as documented by pregnancy tests).
- •All females that are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- •Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period. If currently abstinent, the subject must agree to use an effective method as described above if she becomes sexually active during the study period. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study.
- •Written informed consent obtained prior to any study specific procedures.
- •Eligible for surgery and specific walking training as judged by the investigator.
排除标准
- •Other life-threatening injury.
- •Serious co-existing medical condition or mental disorder.
- •Results from neurophysiological examination preoperatively are inconsistent with a spinal cord injury of one thoracic segment or less.
- •Current or prior (within the past 8 weeks or within 5 half-lives of use of such a medication prior to screening) participation in any other investigational medication or device trial.
- •Known hypersensitivity to FGF1 or heparin.
- •Subjects unable to tolerate or undergo MRI scanning, including subjects with claustrophobia unless sedation can be used, cardiac pacemaker/defibrillator, ferromagnetic metal implants e.g., in skull, cardiac devices, other than those approved as safe for use in MR scanners.
- •Ongoing drug or alcohol abuse or dependence.
- •Positive serology for Hepatitis B or C, or Human Immunodeficiency Virus (HIV) at Screening.
- •Positive test for Methicillin-resistent Staphylococcus Aureus (MRSA) at screening.
- •Any disease, concomitant injury, condition or treatment that interferes with the specific walking training, the performance or interpretation of the neurological examination.
- •Has a condition or has received medical treatment that, in the judgment of the investigator, precludes successful participation in the study.
- •Previous radiation treatment (e.g. cancer treatment) in the region of the spinal cord injury.
结局指标
主要结局
Proportion of subjects with an Adverse Event
时间窗: 0 - 18 months
Proportion of subjects with an improvement, in the Motor Evoked Potential (MEP) scores
时间窗: 0 - 18 months
次要结局
未报告次要终点
研究者
研究点 (1)
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