Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A
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.
| Condition(s) | Spinal Cord Injury, Acute, Spinal Cord Injury at C4 Level With Complete Lesion, Spinal Cord Injury at C5-C7 Level With Complete Lesion |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Upon written consent of the patient or the legally acceptable representative of the patient 2. Male and female patients 18 to 65 years of age 3. 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\* \*Dual contraceptive method: Method of using multiple contraceptives, such as using a cervical cap or contraceptive diaphragm in addition to a condom for males 4. Patients who are capable |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | S.Biomedics Co., Ltd. |
| Locations | Suwon, Gyeonggido, South Korea; Seoul, South Korea |
| Start date | 2021-09-23 |
| NCT ID | NCT04812431 |
| Official listing | https://clinicaltrials.gov/study/NCT04812431 |