A non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT in subjects with acute spinal cord injury - A non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT in subjects with acute spinal cord injury

Kringle Pharma, Inc.0 sites25 target enrollmentJuly 18, 2020

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Kringle Pharma, Inc.
Enrollment: 25
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 18, 2020

End Date

March 30, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Kringle Pharma, Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

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 spinal cord injury (SCI), 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