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

Kringle Pharma

Status and phase

Enrolling

Phase 3

Conditions

Acute Spinal Cord Injury

Treatments

Drug: KP-100IT

Study type

Interventional

Funder types

Industry

Identifiers

NCT04475224

KP-100-ND004

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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