KCT0005628招募中未知
A single center, open label, single group, phase 1/2a clinical study to evaluate the safety and exploratory efficacy of transplantation therapy using neural precursor cells (PSA-NCAM(+) NPC) derived from human embryonic stem cell line in AIS-A level of sub-acute spinal cord injury (from 7 to 60 days)
S.Biomedics0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 5
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
- 18(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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 <30%/10 g/dL
- •-Total WBC < 103/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)
- •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
研究者
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