EUCTR2013-000906-52-SE进行中（未招募）1 期
An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Human Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects with Traumatic Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioArctic AB
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Traumatic Spinal Cord Injury
- •2. Male or female subjects aged between 18 and 65 years.
- •3. Body Mass Index (BMI) =35, body weight =125 kg and height = 195 cm at Screening.
- •4. Complete spinal cord injury (ASIA Impairment Scale level A, no voluntary bladder function, negative motor and sensory evoked potentials).
- •5. A single spinal cord lesion injury at the neurologic level between T2-T11
- •6. A Baseline MRI that indicates a pathology consistent with a traumatic SCI
- •7. 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 as judged from the MRI assessment.
- •8. Females must not be lactating or pregnant at Screening or pre-surgery (as documented by negative pregnancy tests).
- •9. All females that are 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).
- •10. 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 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 a double-barrier 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.
- •11. Written informed consent obtained prior to any study specific procedures.
- •12. Eligible for surgery and specific walking training as judged by the investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Other life-threatening injury.
- •2. Serious co-existing medical condition or mental disorder.
- •3. Results from neurophysiological examination preoperatively are inconsistent with a spinal cord injury of one thoracic segment or less.
- •4. 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.
- •5. Known hypersensitivity to , FGF1 or heparin
- •6. 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.
- •7. Ongoing drug or alcohol abuse or dependence.
- •8. Positive serology for Hepatitis B or C, or Human Immunodeficiency Virus (HIV) at Screening.
- •9. Positive test for Methicillin-resistant Staphylococcus Aureus (MRSA) at screening.
- •10. Any disease, concomitant injury, condition or treatment that interferes with the specific walking training, the performance or interpretation of the neurological examination.
- •11. Has a condition or has received medical treatment that, in the judgment of the investigator, precludes successful participation in the study.
- •12. Previous radiation treatment (e.g. cancer treatment) in the region of the spinal cord injury.
研究者
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