Phase I/II Study of KP-100IT in Acute Spinal Cord Injury

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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 injection, as a treatment for acute spinal cord injury. The study is conducted at two clinical sites in Japan.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kringle Pharma, Inc.
• Treatments: Mitogens

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