Clinical Trials/JPRN-UMIN000014434

JPRN-UMIN000014434

Completed

Phase 1

Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury - Phase I/II study of KP-100IT in acute spinal cord injury

Kringle Pharma, Inc.0 sites48 target enrollmentJune 30, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Kringle Pharma, Inc.
Enrollment: 48
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 30, 2014

End Date

May 11, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Kringle Pharma, Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•\-Spinal cord injury at C1\-C2 or C2\-C3 level \-Patients not 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, abnormality in spinal cavity, or considerable meningeal damage \-Evaluation of safety and efficacy will not be conducted adequately by damage on brain, organs or multiple injuries \-High\-dose steroid therapy within 30 days before the entry \-Patients who have diseases such as serious liver disorder, renal disorder, heart 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 drugs scheduled to be used in the study \-Administration of the study drug to the area of spinal cord injury is not appropriate because of 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

Outcomes

Primary Outcomes

Not specified

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