Clinical Trials in South Korea / NCT04812431
Recruiting
Phase 1/2
Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI
NCT04812431 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Spinal Cord Injury, AcuteSpinal Cord Injury at C4 Level With Complete LesionSpinal Cord Injury at C5-C7 Level With Complete Lesion
Investigational drug(s) / intervention(s)
Neural precursor cells derived from human embryonic stem cell line
Neural precursor cells derived from human embryonic stem cell line: When 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.
Study 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.
Eligibility
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 of being administered with the investigational product on Day 7 to 60 after spinal cord injury
5. Patients who have been confirmed to have spinal cord injury classified as AIS-A on ISNCSCI, SCIM and/or MRI by the investigator, physiatrist, or other spinal cord injury specialist
6. Patients whose ASIA Impairment Scale (AIS) satisfies AIS-A criteria (spinal segment within C4-C7, complete injury)
Exclusion Criteria:
1. Patients with spinal cord injury caused by penetrating trauma such as gunshot or stab wounds
2. Patients with complete transection on the spinal cord
3. Patients with spinal cord injury that require more than the mono-segment treatment
4. 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
5. Patients with multiple lesions or lesions longer than 2 cm in length found on MRI examination
6. Patients administered with cells excluding blood transfusion before participating in the clinical study
7. Patients with the following intercurrent diseases or conditions:
1. Coagulopathy with INR\> 1.4 at the time of administration of the investigational product (Day 0)
2. Active infection
3. Active hypotension requiring vasoconstrictor treatment (less than 60 mmHg of diastolic blood pressure)
4. Rupture of the skin on the area of surgery
5. Medical history of malignant tumor
6. Primary or secondary immunodeficiency
7. Clinically significant abnormal values discovered as a result of laboratory tests
* Creatinine \> 1.5 mg/dL
* When the level found in the liver-function examination is more than twice the upper limit of the normal level
* Hematocrit/hemoglobin \<30%/10 g/dL
* Total WBC \< 1000/μL
* Uncontrolled hypertension (systole\> 180 mmHg or diastole\> 100 mmHg)
* Uncontrolled diabetes (HbA1c\> 8%)
* Evidence of GI bleeding on the stool guaiac test
* Positive on tuberculosis test (However, a chest X-ray may be performed if found positive on the TB test, and the patient may be enrolled upon no findings that suggest active tuberculosis on the chest X-ray.)
* Hepatitis B or C
* Human Immunodeficiency Virus (HIV)
8. Substance abuse or alcoholism
9. Unstable or untreated psychiatric disorder
8. Patients with known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, methylprednisolone, or prednisone
9. Patients incapable of receiving physical therapy or combination therapy
10. Patients incapable of going under general anesthesia due to other reasons
11. Patients judged unsuitable for participation in this clinical study by the investigator
Primary outcome measure(s)
- Changes of occurred adverse events during the clinical study — Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks), Telephone visit 1(13 weeks), Telephone visit 2(14 weeks), Telephone visit 3(16 weeks)
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 — Visit 1(Screening), Visit 11(72 weeks)
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) — Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
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) — Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using body temperature (degrees Celsius) from the baseline (Visit 1) to the end of the clinical study (Visit 11). - Measured changes of Heart rate (beats per minute) — Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using heart rate (beats per minute) from the baseline (Visit 1) to the end of the clinical study (Visit 11). - Measured changes of Respiratory rate (breaths per minute) — Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using respiratory rate (breaths per minute) from the baseline (Visit 1) to the end of the clinical study (Visit 11). - Rate of abnormal hematology values — Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using hematology values(WBC, WBC differential, RBC, Hemoglobin, Hematocrit, and Platelet). - Rate of abnormal chemistry values — Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using chemistry values(Sodium, Potassium, Calcium, Chloride, Inorganic Phosphate, SGOT(AST), SGPT(ALT), Alkaline Phosphatase, GGT, Creatinine, BUN, Total Bilirubin, Total Protein, Albumin, and Glucose). - Rate of abnormal urinalysis values — Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Assessment of the normal/abnormal changes at the baseline (Visit 1) and changes at the end of the clinical study (Visit 11) as measured value using urinalysis values(Protein, Glucose, Ketones, and Occult Blood). - Measured changes of diastolic blood pressure (mm Hg) — Visit 1(Screening), Visit 2(-2 Day), Visit 3(Day 0), Visit 4(1 week), Visit 5(2 weeks), Visit 6(4 weeks), Visit 7(8 weeks), Visit 8(12 weeks), Visit 9(24 weeks), Visit 10(48 weeks), Visit 11(72 weeks)
Comparative assessment of measured value using diastolic blood pressure (mm Hg) from the baseline (Visit 1) to the end of the clinical study (Visit 11).
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Ajou University Hospital | Suwon | Gyeonggido | Recruiting |
| Yonsei University Health System, Severance Hospital | Seoul | South Korea | Recruiting |
More S.Biomedics Co., Ltd. trials in South Korea
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04812431 on ClinicalTrials.gov ↗ ← All trials in South Korea