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Not Yet Recruiting NCT07722962

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

Conditions: Acute Spinal Cord Injury (SCI)

Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 10
Sponsor: Kringle Pharma, Inc.

Location: Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries Center Iizuka Fukuoka

Summary

This is a Phase 3, multicenter, open-label, single-arm additional study to evaluate the efficacy of intrathecal KP-100IT in patients with acute spinal cord injury. Eligible patients will receive KP-100 0.6 mg/body by intrathecal administration once per week for a total of 5 doses and will be followed for approximately 24 weeks after the first dose.

Eligibility Criteria

Inclusion Criteria: * Patients whose AIS grade is A at 72 hours (± 6 hours) after injury * age: 18 years to 89 years * MRI imaging and other tests confirm the continuity of the spinal cord Exclusion Criteria: * The injury site is C1-C2 or C2-C3 * The patient with a spinal crd compression rate of 70% or higher. * The patient in whom a spinal cord rupture is strongle suspected. * The patient cannot start rehabilitation necessary for recovery of function at an early stage. * External trauma or concurrent organ injury. * High dose steroid therapy administered for the treatment of spinal cord injury * History or concurrent presence of malignant tumor. * It is inappropriate for the subject to be included in the study, in the opinion of the investigator.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07722962). StuddyBuddy aggregates publicly available trial information.