Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury
- Conditions
- Spinal Cord Injury
- Registration Number
- JPRN-UMIN000014434
- Lead Sponsor
- Kringle Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 48
Not provided
-Spinal cord injury at C1-C2 or C2-C3 level -Patients not 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, abnormality in spinal cavity, or considerable meningeal damage -Evaluation of safety and efficacy will not be conducted adequately by damage on brain, organs or multiple injuries -High-dose steroid therapy within 30 days before the entry -Patients who have diseases such as serious liver disorder, renal disorder, heart 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 drugs scheduled to be used in the study -Administration of the study drug to the area of spinal cord injury is not appropriate because of 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method