Phase I/II study of KA-301 for acute spinal cord injury

JRCT ID: jRCT2043230067

Registered date:08/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute spinal cord injury
• Date of first enrollment: 10/08/2023
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Administer investigational product within 128-144 hours after injury.

Outcome(s)

Primary Outcome

General safety
Change from Day 1 in ASIA exercise score (score at 24 weeks - Day 1 score)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

(1)Patients who are between 18 and 75 years of age at the time consent is obtained
(2)Patients with cervical spinal cord injury within 144 hours of injury whose severity at screening was determined to be B on the ASIA impairment scale.
(3)Patients whose severity at the time of enrollment (128-144 hours after injury) is the same as the ASIA impairment scale at the time of selection criteria (2) screening, and who can start receiving the investigational product within 144 hours after injury
(4)Patients with neurological injury levels C4 to C7 according to the ISNCSCI (C4 patients must have at least 1 point of motor activity between C5 and C7)
(5)Patients whose consent to participate has been obtained in writing from the individual (or a substitute, if necessary)
(6)Patients able to be evaluated at 12, 24 and 52 weeks

Exclude criteria

(1) Patients with hypersensitivity to any of the components of the investigational product, concomitant succinate (or phosphate) ester hydrocortisone sodium or chlorpheniramine maleate
(2) Patients with concomitant or pre-existing hematopoietic malignant diseases such as leukemia
(3)Patients with concomitant cancers or with a history of cancers within 3 years
(4)Patients who have undergone invasive treatment for myocardial infarction or angina pectoris within 24 weeks
(5)Patients with a history of thrombosis or embolism
(6)Patients with splenomegaly requiring medical treatment
(7) Patients with impaired consciousness or respiratory impairment requiring ventilator management
(8)Patients with respiratory complications such as chronic obstructive pulmonary disease or interstitial lung disease requiring management such as oxygen inhalation
(9)Patients with chronic systemic fungal or viral infections
(10)Women who are pregnant, of childbearing potential, intending to become pregnant during the study, or breast-feeding
(11)Patients with neurological, cerebrovascular, or musculoskeletal disorders that may affect the evaluation of neurological symptoms
(12)Patients who have received methylprednisolone succinate sodium (MPSS) high-dose therapy (a high-dose regimen for spinal cord injury) after injury
(13)Patients whose symptoms are expected to deteriorate rapidly during this study
(14)Patients who cannot start rehabilitation early due to complications
(15)Patients with severe dementia or psychiatric disorders
(16)Patients with multiple traumatic injuries or organ damage and unstable general condition.
(17)Patients with fractures of the extremities, spine, or other parts of the body, or high-energy trauma that may affect the evaluation
(18)Patients who are currently participating in another study or have received an investigational drug or treatment with an investigational device within 12 weeks of participating in another study
(19)Patients weighing less than 30 kg or more than 120 kg
(20)Other patients who are judged to be inappropriate for participation in this study by the investigator and sub-investigator

Related Information

• Primary Sponsor: Maeda Takeshi