The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Lumbar Discogenic Pain
The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Lumbar Discogenic Pain
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.
Inclusion Criteria:

 1. age over 18

 2. refractory and persistent lumbago pain for more than 6 months, with/without radiation
 pain in lower limbs, and poor conservative treatment effect;

 3. the straight leg elevation test was 70 degrees negative;

 4. 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.

 5. clinical signs of nerve localization were consistent with MRI changes;

 6. subject gives informed consent and signs informed consent.

 Exclusion Criteria:

 1. coagulation dysfunction or anticoagulant therapy;

 2. intervertebral space infection, puncture site infection or systemic infection;

 3. lumbago pain of non-spinal origin, such as sacroiliac joint origin pain;

 4. patients who have had open surgery or other disc treatments;

 5. imaging examination suggested disc prolapse, prolapse, spinal canal bone stenosis,
 etc.;

 6. patients with vital organ system dysfunction and tumor lumbar vertebra metastasis;

 7. subjects with high tumor markers (AFP/CEA/CA199/CA125);

 8. the subject is pregnant or breastfeeding;

 9. subjects also receive other treatments that may affect the efficacy and safety of stem
 cells;

 10. failing to control alcohol and other substance abuse during the 6 months prior to
 enrollment and enrollment period;

 11. 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;