KCT0007731尚未招募未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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