Clinical Safety Study of the Application of CRIS100 in Participants With Acute Spinal Cord Injury
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 5
- 主要终点
- Hemoglobin
研究概览
简要总结
The goal of this clinical trial is to test CRIS100 treatment in participants with acute thoracic spinal cord injury. The main questions it aims to answer are:
- safety of CRIS100
- efficacy of CRIS100
Participants will receive 100 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.
详细描述
Participants with complete spinal cord injury between T2 and T10 (ASIA A, according to ISNCSCI, 2019 revision) and:
- occurred less than 72 hours ago
- with surgical indication
- bulbocavernous reflex present
- who can receive treatment with CRIS100 within 72 hours after the trauma (preferably within 24 hours)
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
- •Signature of the Free and Informed Consent Term by the participant or legal guardian
- •Age between 18 and 70 years old;
- •Thoracic spinal cord injury between T2 and T10, with surgical indication, occurred less than 72 hours before surgery;
- •Presence of bulbo cavernosum reflex;
- •Patients with a lesion classified as ASIA A according to the ISNCSCI (2019 revision);
排除标准
- •Absence of bulbocavernous reflex up to 72 hours after the trauma.
- •Presence of severe brain trauma.
- •Patients with lesions above T2 or below T
- •More than one site of spinal cord injury.
- •History of alcohol or illicit drug abuse, as defined by DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition or later).
- •Patients who need permanent mechanical respiratory support.
- •Polytraumatized patients who, in the investigator's assessment, compromise the neurological evolution.
- •Neurological diseases or functional dependence of any etiology prior to the trauma.
- •Any other comorbidity that, at the discretion of the investigator, makes it impossible to include the patient in the study.
研究组 & 干预措施
CRIS100 treatment
Administration of a single dose of CRIS100
干预措施: CRIS100 (Drug)
结局指标
主要结局
Hemoglobin
时间窗: 6 months
Decrease in hemoglobin concentration greater than 20% of the lower limit of normal
Imaging exams
时间窗: 6 months
Changes in spinal cord imaging (MRI or CT) that indicate worsening of the primary lesion
Anti-drug antibodies (ADA)
时间窗: 6 months
Developing anti-CRIS100 antibodies
Liver function
时间窗: 6 months
Liver enzyme values more than 2 times higher than the upper limit of normal.
Serious adverse events (SAE)
时间窗: 6 months
Possible, probable, or definitely CRIS 100-related SAE
Kidney function
时间窗: 6 months
Plasma urea and/or creatinine concentration above 2 times the upper limit of normality
White blood cell (WBC)
时间窗: 6 months
Increase in WBC count greater than 20% of the upper limit of normal
次要结局
- Efficacy of CRIS100(6 months)