Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI

Launched by S.BIOMEDICS CO., LTD. · Mar 22, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of treatment for people with spinal cord injuries who are experiencing paralysis and related symptoms. The treatment involves using special cells called neural precursor cells, which are derived from human embryonic stem cells. The goal is to see if these cells can help improve movement and function after a spinal cord injury that occurred between 7 to 60 days prior to treatment.

To participate in this trial, you need to be between 18 and 65 years old, have a specific type of spinal cord injury classified as AIS-A (which means a complete injury at the C4 to C7 level), and be able to provide informed consent. Women must not be pregnant and should use reliable contraception, while men should also use contraceptives during the trial. Participants will receive the transplant and will be monitored for safety and any potential improvements in their condition. It's important to note that certain medical conditions and previous treatments may make someone ineligible for this study, so discussing your health history with the research team is essential.

Gender

ALL

Eligibility criteria

• 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