A study to evaluate the safety of transplantation therapy using microspheroids assembled by peripheral nerve-derived adult stem cells in acute,sub-acute spinal cord injury patients
- Conditions
- Injury, poisoning and certain other consequences of external causes
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 6
1)Patient or substitute agreed with written consent
2)Patients with more than 19 years old
3)Female patients with negative in pregnancy test, acceptable contraceptive method, being not possible of pregnancy (more than 2 years after menopause, history of hysterectomy, oophorectomy, or sterilization operation) or male patients who underwent vasectomy or are willing to do double block contraceptive method* until 90 days post-administration.
*Double block contraceptive method : complex contraceptive method such as male condom combined with cervix cap or contraceptive diaphragm
4) Patients who are able to get clinical trial of medication at 180 days post-spinal cord injury
5) Patients with spinal cord injury was confirmed as ASIA-A to C with ISNCSCI, SCIM and/or MRI by experimenter, physiatrist, or other specialist in spinal cord injury
6) Patients who meet ASIA criterion
a. Group A : complete spinal cord injury at C4-C7 level, ASIA-A
b. Group C : preserved some motor and sensory function, incomplete spinal cord injury at C4-C7 level, ASIA C, lower extremity total motor score less than 25
1)Spinal cord injury caused by penetrating injuries such as gunshot or stab wound
2)Spinal cord injury with complete cord transection
3)Spinal cord injury including long segments
4)Patients with peripheral nerve injury (neuromuscular injury, central cord syndrome)-related nervous system damage or underlying disease related paraplegia or sensorimotor defect
5)On MRI, lesion confirmed of multiple segmental or more than 2cm
6)Spinal cord injury patient diagnosed with ASIA D on ISNCSSCI, SCIM or MRI
7)Patients who administered cell therapy except transfusion before clinical trial drug
8)Patients who have diseases or conditions followed as
a.Coagulopathy (INR >1.4) at administration of clinical trial drug (Day 0)
b.Active infection
c.Hypotension requiring vasoconstrictor treatment (diastolic BP < 60mmHg)
d.Dermatorrhexis on surgical wound
e.History of malignant tumor
f.Primary or secondary immunodeficiency
g.Clinically abnormal laboratory results
-Serum Cr > 1.5 mg/dL
-If upper-normal value is more than two times on liver function test
* SGOT/SGPT: ~34/46 IU/L, Total Bilirubin: Male ~ 1.8, Female ~ 1.5 mg/dL,
Alk Phos: ~ 147 IU/L
-Hct/Hb < 30%/10 g/dL
-Total WBC < 103/µL
-Uncontrolled hypertension (systolic > 180 mmHg or diastolic > 100 mmHg)
-Uncontrolled diabetes (HbA1c > 8%)
-GI bleeding evidence on stool OB
-Tuberculosis (confirmed by chest X-ray)
-Hepatitis B or C
-Human immunodeficiency virus (HIV)
h. drug abuse or alcoholism
i. unstable or untreated psychiatric disease
9) allergic reaction to Basiliximab, tacrolimus, mycophenolate mofetil, methylprednisolone or prednisone
10) patient who cannot perform physical therapy or combination therapy
11) patient who cannot perform general anesthesia
12) patient who is not suitable for clinical trial participation
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Advers event 2. Phisical Exam 3. Vital Sign 4. Laboratory Test Result
- Secondary Outcome Measures
Name Time Method 1. Remaining of transplatation cells in MRI 2. Rejection response against the transplatation cells 3.Changes of ASIA scale 4. International Standards for neuriloical classification of spinal cord injury(ISNCSCI) motor sensory index score 5. Pain 6. Spinal Cord Independence Measure(SCIM) score