Status:
RECRUITING
Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI
Lead Sponsor:
S.Biomedics Co., Ltd.
Collaborating Sponsors:
Linical Co., Ltd.
Yonsei University
Conditions:
Spinal Cord Injury, Acute
Spinal Cord Injury at C4 Level With Complete Lesion
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 tre...
Detailed Description
Subjects with damage to C4-C7 cords diagnosed as AIS-A are administered with PSA-NCAM(+) NPC. For evaluation of safety and exploratory efficacy, 2 to 6 subjects will be enrolled depending on the pres...
Eligibility Criteria
Inclusion
- 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\*
- \*Dual contraceptive method: Method of using multiple contraceptives, such as using a cervical cap or contraceptive diaphragm in addition to a condom for males
- Patients who are capable of being administered with the investigational product on Day 7 to 60 after spinal cord injury
- 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
- Patients whose ASIA Impairment Scale (AIS) satisfies AIS-A criteria (spinal segment within C4-C7, complete injury)
Exclusion
- 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
- Patients with multiple lesions or lesions longer than 2 cm in length found on MRI examination
- Patients administered with cells excluding blood transfusion before participating in the clinical study
- Patients with the following intercurrent diseases or conditions:
- Coagulopathy with INR\> 1.4 at the time of administration of the investigational product (Day 0)
- Active infection
- Active hypotension requiring vasoconstrictor treatment (less than 60 mmHg of diastolic blood pressure)
- Rupture of the skin on the area of surgery
- Medical history of malignant tumor
- Primary or secondary immunodeficiency
- 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)
- Substance abuse or alcoholism
- Unstable or untreated psychiatric disorder
- Patients with known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, methylprednisolone, or prednisone
- Patients incapable of receiving physical therapy or combination therapy
- Patients incapable of going under general anesthesia due to other reasons
- Patients judged unsuitable for participation in this clinical study by the investigator
Key Trial Info
Start Date :
September 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04812431
Start Date
September 23 2021
End Date
September 1 2030
Last Update
May 18 2025
Active Locations (2)
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1
Ajou University Hospital
Suwon, Gyeonggido, South Korea, 16499
2
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722