About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Neural precursor cells derived from human embryonic stem cell line