None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : This is Single group and open label in phase 1/2a clinical study. Cells are administered through intrathecal injection. Injection is administered to a total of five are
one injection each on both sides of the injured area 5 mm from the upper boundary 10 mm center line, one injection each on both sides of the injured area 5 mm from the lower 10 mm center line, and one
Sponsors
S.Biomedics
Eligibility
Sex/Gender
All
Inclusion 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 Patients whose ASIA Injury Scale (AIS) satisfies AIS-A criteria (spinal segment within C4-C7, complete injury)
Exclusion criteria
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: a. Coagulopathy with INR> 1.4 at the time of administration of the investigational product (Day 0) b. Active infection c. Active hypotension requiring vasoconstrictor treatment (less than 60 mmHg of diastolic blood pressure) d. Rupture of the skin on the area of surgery e. Medical history of malignant tumor f. Primary or secondary immunodeficiency g. 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 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) h. Substance abuse or alcoholism i. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant rejection against transplanted cells;Changes in the ASIA Damage Scale;International standards for neurological classification of spinal cord injury (ISNCSCI) motor and sensory index score;Pain;Spinal Cord Independence Measure (SCIM) score;Adverse Event;Vital Signs;Graft survival at the transplant site as observed in MRI examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical Examination;Laboratory Test | — |
Countries
Korea, Republic of
Contacts
Public ContactDong Shin
Yonsei University Health System, Severance Hospital
Outcome results
None listed