Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old

• Patients who have suffered a cervical spinal cord injury within the past 78 hours whose AIS classification was A at 66 - 78 hours after injury-Written informed consent has been obtained

Exclusion Criteria:

• The injury site is C1-C2 or C2-C3

• The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary

• It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury

• A history of SCI (Spinal cord injury), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI

• Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury

• High dose steroid therapy administered for spinal cord injury

• Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy

• History of malignant tumor

• Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration

• Drug allergies to drugs that will be (or may be) used

• Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass

• Problems with the subject's ability to give informed consent in person

• The subject is breastfeeding or possibly pregnant

• The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator

• It is inappropriate for the subject to be included in the study, in the judgement of the investigator