Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02193334
Eligibility Criteria:
Inclusion Criteria:
* Age equal to or greater than 18 years and equal to or less than 75 years
* Cervical spinal cord injury, and Grade A, B1 or B2 in the modified Frankel Scale at 72 hours since the injury
* Subjects able to provide written informed concent, which may require a relative to sign if arm/hand function of the subject is compromised
Exclusion Criteria:
* Spinal cord injury at C1-C2 0r C2-C3 level
* Patients not to able to start rehabilitation within a week by setup of respirator or other reason
* First dose of the study drug will not be given within 78 hours since the injury
* History of spinal cord injury or abnormality in spinal cavity. Or current considerable meningeal damage
* Outcome assessment will not be conducted adequately through damage on injuries other than the injury
* High-dose steroid therapy within 30 days before the entry
* Patients who have diseases such as serious liver disorder, renal disorder, hear disease, blood dyscrasia, metabolism disorder and infections
* History of malignant tumor
* Patients who participated in other clinical study within 30 days before the entry
* Patients who have allergies to drug scheduled to be used in the study
* Administration of the study drug to the area of spinal cord injury is not appropriate for example by intrathecal infections or intrathecal tumor
* Patients not able to understand "informed consent" properly
* Patients who are nursing or may be pregnant
* Investigator considers that the patient is not appropriate for participating in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02193334
Study Brief:
Protocol Section:
NCT02193334