Status:
COMPLETED
Phase I/II Study of KP-100IT in Acute Spinal Cord Injury
Lead Sponsor:
Kringle Pharma, Inc.
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is randomized, double-blind, placebo-controlled Phase I/II study designed to evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation for intrathecal inj...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02193334
Start Date
June 30 2014
End Date
July 31 2018
Last Update
June 5 2019
Active Locations (2)
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1
Spinal Injuries Center
Iizuka, Fukuoka, Japan, 820-8508
2
Hokkaido Chuo Rosai Hospital Sekison Center
Bibai, Hokkaido, Japan, 072-0015