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.
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. The prime efficacy evaluation is VAS( visual analogue scale) at the 3, 6, 12 and 24 weeks before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
2\*10\^7
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGValidity 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
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%
Time frame: 24 weeks
Observe treatment
Secondary measures were assessed at 3, 6, 12 and 24 weeks before and after treatment, including: Subjective indicators: ODI(The Oswestry Disability Index) score: 0%-20%: Minimal disability: This group can cope with most living activities. Don't need treatment. 20%-40% Moderate disability: This group experiences more pain and problems with sitting, lifting, and standing. Personal care, sexual activity, and sleeping are not grossly affected, and the back condition can usually be managed by conservative means. 40%-60%: Severe disability: Pain remains the main problem in this group of patients, but travel, personal care, social life, sexual activity, and sleep are also affected. 60%-80%: Crippled: Back pain impinges on all aspects of these patients' lives-both at home and at work-and positive intervention is required. 80%-100%: These patients are either bed-bound or exaggerating their symptoms. Need evaluated by careful observation of the patient during medical examination.
Time frame: 24weeks
Safety evaluation by detecting adverse events and serious adverse events
Observe for any adverse reactions, including fever, pain, or bleeding to evaluate the changes of safety indexes at the 3、6、12、24weeks after treatment.
Time frame: 24 weeks
Safety evaluation by detecting Activated partial thromboplastin time (APTT)
Being the Activated partial thromboplastin time (APTT) test for the patients to examine the changes of safety indexes at the 3、6、12、24 weeks after treatment. time of 25-37 seconds. Abnormalities over 10 seconds should be compared with normal controls.
Time frame: 24 weeks
Safety evaluation by detecting Prothrombin time (PT)
Being the Prothrombin time (PT) test for the patients to examine the changes of safety indexes at the 3、6、12、24 weeks after treatment. time of 11-14 seconds. Abnormalities over 3 seconds in comparison with normal controls are required. Activity: 80-120% INR: 0.8-1.2
Time frame: 24 weeks
Safety evaluation by detecting Fibrinogen
Fibrinogen test for the patients to examine the changes of safety indexes at the 3、6、12、24 weeks after treatment. The Fibrinogen should in 2-4g/L
Time frame: 24 weeks
Safety evaluation by detecting Thrombin time (TT)
Thrombin time (TT) test for the patients to examine the changes of safety indexes at the 3、6、12、24 weeks after treatment. the time of 12-16 seconds, TT need to be abnormal for more than 3 seconds compared with normal controls
Time frame: 24 weeks
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