NCT05011474Unknown1 期
Safety and Efficacy Study of Matrilin-3 Pretreated Autologous Adipose Derived Mesenchymal Stem Cells Implantation in Chronic Low Back Pain Patients With Lumbar Intervertebral Disc Degeneration
Inbo Han1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年4月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- 1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection
研究概览
简要总结
To investigate the safety and efficacy of autologous adipose-derived mesenchymal stem cell spheroids pretreated with matrillin-3 in chronic low back pain patients with lumbar intervertebral disc degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 19-70 years
- •Among the subjects with low back pain, conventional conservative treatment is performed, but the back pain or hip pain persists for more than 3 months, and it is determined that the cause of the back pain is a degenerative disc (MRI checks for a degenerative disc)
- •Has Oswestry Disability score(ODI) ≥ 30%
- •Has Visual Analogue Scale(VAS) ≥ 4
- •Between lumbar 1-sacral 1, Magnetic Resonance Imaging (MRI) grade according to the Pfirrmann classification is 3~
- •Has one or two degenerative lumbar discs identified by MRI (Confirmation of low back pain due to disc through various nerve block procedures.)
- •Consent was prepared for stem cell administration
排除标准
- •Patient requiring surgery due to severe pain in lower extremities due to severe nerve compression due to severe lumbar stenosis or prolapse of lumbar nucleus.
- •patient with spinal instability, spondylitis, or vertebral fracture
- •type 3 Modic change is in an endplate
- •Patient whose disc height has decreased by more than 1/2 due to severe disc degenerative change
- •Patient with severe osteoporosis (The average value of the T score in the lumbar spine bone density test is -2.5 or less)
- •has undergone surgery, such as disc resection, on the disc to which the cells will be administered
- •Patient who received lumbar epidural steroid injection 3 weeks before cell administration
- •Pregnant or lactating women
- •Among female patients who are likely to become pregnant during the clinical trial, who do not use medically acceptable methods of contraception
- •medically acceptable methods of contraception: condom, Oral contraception lasting for at least 3 months, Has received an infusion pill before 3 months, using an injectable or implantable contraceptive, or installed an intrauterine contraceptive device
- •has a history of psychiatry or who are currently undergoing treatment, who judged that it is difficult to proceed with the clinical trial under the judgment of the researcher
- •Patient with drug or alcohol addiction who cannot understand the purpose and method of this clinical trial
- •Patient who participated in other clinical trials within 3 months prior to participation in the trial
- •Patient who may affect this clinical trial due to serious medical conditions (hypertension not controlled by drugs, diabetes not controlled by drugs, cirrhosis, kidney failure, tumors)
- •Patient with a history of malignant tumors within the last 5 years
- •has a history of administration of cell therapy products
- •Other persons who have clinically significant findings deemed inappropriate for this clinical trial due to medical judgment by the person in charge of the clinical trial
结局指标
主要结局
1) Adverse reaction and serious adverse reaction evaluation 2) laboratory inspection 3) Vital signs 4) Biochemical examination 5) Lumbar MRI 6) Monitoring systemic infection
时间窗: During Clinical Trial Period
It will be considered safe and tolerated in the absence of the following: * Grade 3 (NCI grading system) or higher adverse reactions related to cell products * Any evidence that the cells are contaminated with infectious substances * Any evidence that cells show tumorigenic potential
次要结局
- Confirmation of the degree of improvement in disability (ODI)(before stem cell injection and at 1 week, 1, 3, and 6 months after injection)
- Confirmation of increase in water content in the nucleus using MRI(before stem cell injection and at 1 and 6 month after injection)
- Confirmation of the degree of pain improvement in VAS(before and at 1 week, 1, 3, 6 months after stem cell injection)
研究者
Inbo Han
Professor, Spine Neurosurgeon, Bundang CHA Hospital
CHA University
研究点 (1)
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