This study intends to evaluate the safety and exploratory efficacy of transplantation therapy using neural precursor cells (PSA-NCAM(+) NPC) derived from the human embryonic stem cell line for the treatment of paralysis and other related symptoms from sub-acute spinal cord injury.
Upon written consent of the patient or the legally acceptable representative of the patient
Male and female patients 18 to 65 years of age
Female patients who showed negative results on the pregnancy test, use an acceptable contraceptive or have no possibility of pregnancy (at least 2 years have elapsed after menopause or have undergone hysterectomy, ovariectomy, or sterilization operation), or male patients who have received vasectomy or are willing to use contraceptives for up to 90 days after administration of the investigational product using a dual contraceptive method*
Patients who are capable of being administered with the investigational product on Day 7 to 60 after spinal cord injury
Patients with spinal cord injury caused by penetrating trauma such as gunshot or stab wounds
Patients with complete transection on the spinal cord
Patients with spinal cord injury that require more than the mono-segment treatment
Patients with other complications, including neurological defects related to peripheral nerve injury (neuromuscular injury or central spinal cord syndrome), or etiological causes of paraplegia or sensorimotor defects related to an additional underlying condition
Single group
Neural precursor cells derived from human embryonic stem cell line
Biological/VaccineWhen the Dose Limiting Toxicity (DLT) is not presented in the first three subjects administered with PSA-NCAM(+) NPC, two additional patients are added to the clinical study.
Changes of occurred adverse events during the clinical study
Assessment of the presentation rate of adverse events occurred from IP administration until the end of the clinical study (Visit 11).
Rate of abnormal signs as assessed through physical examination
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as assessed through physical examination (appearance, skin, head/neck, chest/lung, heart, abdomen, genitourinary system, extremities, musculoskeletal system, nervous system, and lymph nodes).
Measured changes of Systolic blood pressure (mm Hg)
Comparative assessment of measured value using systolic blood pressure (mm Hg) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Measured changes of Body temperature (degrees Celsius)
Comparative assessment of measured value using body temperature (degrees Celsius) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Assessment of Graft survival at the transplant site as observed in MRI examination
Number of participants with measured value(spinal cord changes, spinal cord atrophy far from the lesion, edema, cystic degeneration, spinal sinus, and diameter change) using MRI examination.
Number of participants with Transplant rejection against transplanted cells
Comparative Assessment of PSA-NCAM(+) NPC-specific antibody that may result in transplant rejection in the HLA antigen/antibody reaction test.
Changes in the ASIA Damage Scale
Number of participants with changes in ISNCSCI ASIA at Week 12 (Visit 8) and Week 72 (Visit 11) of administration compared to the baseline (Visit 1).
International standards for neurological classification of spinal cord injury (ISNCSCI) motor index score
Number of participants with motor level recovered\* at Week 4 (Visit 6), Week 12 (Visit 8), Week 24 (Visit 9), Week 48 (Visit 10), and Week 72 (Visit 11) of drug administration compared to the baseline (Visit 1). \* Recovery: Subjects with recovery of at least 2 stages in the upper limb motor score
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