The Safety/Efficacy Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Lumbar Discogenic Pain
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Validity evaluation by detection the change of the VAS pain score relief rate for Lumbar disc pain of participants in different time point and compare with the VAS pain score before treatment
研究概览
简要总结
This experimental use umbilical cord mesenchymal stem cells in treatment of the early stage of lumbar discogenic pain (endogenous pain of the disc) to evaluate its safety and efficacy.
This experimental is mainly aimed at over 18years old people, regardless of gender, with refractory and persistent back pain for more than 6 months.
The efficacy and safety of mesenchymal stem cells (MSCS) were evaluated by low-temperature plasma ablation and intravertebral disc injection, which were divided into treatment group and control group.
详细描述
This experimental use umbilical cord mesenchymal stem cells in treatment of the early stage of lumbar discogenic pain (endogenous pain of the disc) to evaluate its safety and efficacy.
This experimental is mainly aimed at over 18years old people, regardless of gender, with refractory and persistent back pain for more than 6 months.
The straight leg elevation test was 70 degrees negative. Magnetic Resonance Imaging (MRI) of the lumbar spine showed herniated disc < 6 mm, no obvious compression of spinal cord and nerve roots. T2-weighted mri of the lumbar spine showed decreased single/multisegment signal in the intervertebral disc (black disc sign) or High intensity zone (HIZ) in the posterior part of the intervertebral disc annulus. The clinical signs of nerve localization were consistent with MRI changes.
The efficacy and safety of mesenchymal stem cells (MSCS) were evaluated by low-temperature plasma ablation and intravertebral disc injection, which were divided into treatment group and control group.
The safety evaluation including:physical examination, vital signs, routine hematuria and faeces, liver and kidney function, blood lipids, electrolytes, coagulation, rapid virus detection, tumor markers, electrocardiogram and adverse reaction records at the 3, 6, 12 and 24 weeks before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18
- •refractory and persistent lumbago pain for more than 6 months, with/without radiation pain in lower limbs, and poor conservative treatment effect;
- •the straight leg elevation test was 70 degrees negative;
- •MRI of lumbar spine showed herniated disc < 6 mm, no obvious compression of spinal cord and nerve roots; T2-weighted mri of the lumbar spine showed decreased single/multi-segment signal (black disc sign) or High signal zone (HIZ) in the posterior part of the intervertebral disc annulus.
- •clinical signs of nerve localization were consistent with MRI changes;
- •subject gives informed consent and signs informed consent.
排除标准
- •coagulation dysfunction or anticoagulant therapy;
- •intervertebral space infection, puncture site infection or systemic infection;
- •lumbago pain of non-spinal origin, such as sacroiliac joint origin pain;
- •patients who have had open surgery or other disc treatments;
- •imaging examination suggested disc prolapse, prolapse, spinal canal bone stenosis, etc.;
- •patients with vital organ system dysfunction and tumor lumbar vertebra metastasis;
- •subjects with high tumor markers (AFP/CEA/CA199/CA125);
- •the subject is pregnant or breastfeeding;
- •subjects also receive other treatments that may affect the efficacy and safety of stem cells;
- •failing to control alcohol and other substance abuse during the 6 months prior to enrollment and enrollment period;
- •the subjects suffer from mental illness, or lack of understanding, communication and cooperation, and cannot be guaranteed to follow the study protocol;
- •Subjects who are not willing to sign informed consent and are participating in other clinical trials or have participated in other clinical trials within 3 months;
研究组 & 干预措施
treatment group A （with mesenchymal stem cell intervention）
observe the effectiveness and safety of patients by injecting human umbilical cord mesenchymal stem cells(2*10^7/ml normal saline) and Low temperature plasma vaporization ablation
干预措施: human umbilical cord mesenchymal stem cell (Biological)
结局指标
主要结局
Validity evaluation by detection the change of the VAS pain score relief rate for Lumbar disc pain of participants in different time point and compare with the VAS pain score before treatment
时间窗: 24 weeks
Recording the VAS scores at 3, 6, 12 and 24 weeks after the operation and compare with the VAS score before the operation. Pain relief rate =(VAS before treatment - VAS after treatment)/VAS before treatment ×100%. VAS scale Use a line with 10 centimeters long as a point between 1 and 10 0 points, no pain, no pain sensation; 1-3 points, mild pain, no effect 4-6 points, moderate pain, affecting work but not life; 7-10 points, severe pain, severe pain, affect work and life. Efficacy evaluation: more than 75% is the basic remission; 50%-75% is effective; 25%-50% effective; Less than 25% is invalid. e.g. the VAS score before the operation is 8, the score in the third week after operation is 6, the pain relief rate is (8-6)/8x 100%=14.3% the VAS score before the operation is 8, the score in the sixth week after operation is 3, the pain relief rate is (8-3)/8x 100%=62.5%
次要结局
- Safety evaluation by detecting adverse events and serious adverse events(24 weeks)
- Safety evaluation by detecting Prothrombin time (PT)(24 weeks)
- Safety evaluation by detecting Fibrinogen(24 weeks)
- Observe treatment(24weeks)
- Safety evaluation by detecting Thrombin time (TT)(24 weeks)
- Safety evaluation by detecting Activated partial thromboplastin time (APTT)(24 weeks)