Discogenic low back pain due to lumbar disc degeneration
Conditions
Interventions
low dose exosomes group:low dose MSCs-exo were injected into the disc
high dose exosomes group:high dose MSCs-exo were injected into the disc
Sponsors
Huazhong University of Science and Technology Union Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The age range is 18-65; 2. Chronic low back pain for at least 3 months, pain mainly in sitting, bending, lifting heavy objects, waist twisting and other cases, after formal analgesic drugs, bed rest, physiotherapy and other conservative treatment still does not relieve; 3. The visual scale of low back pain (VAS 10-point scale) was >= 4 and = 20 and <= 90; 5. There were no obvious radiating pain symptoms of lower limbs; 6. There were no more than 2 lumbar disc segments of degeneration, the disc height of the lesion was not more than 30%, and the modified Pfirrmann rating was between grades 4 and 6 in MRI; 7. There was no severe endlaminitis in the degraded intervertebral disc and the Modic grade was lower than III; 8. The patient was diagnosed with discogenic low back pain by discography; 9. Excluding non-specific low back pain, myofasciitis, lumbar facet joint disorders; 10. In the case of fertile women, the pregnancy test results were negative at the time of enrollment and during the study period and they received appropriate contraceptive methods; 11. Patients are able to understand the content and nature of this study and sign informed written consent;
Exclusion criteria
Exclusion criteria: 1. Age 65 or older or under 18; 2. Allergic to local anesthetics or hyaluronic acid; 3. MRI showed the presence of 3 or more lumbar disc degeneration and a modified Pfirrmann rating higher than grade 6 or lower than grade 4; 4. Lower back pain VAS score below 4 or above 8; 5. Lumbar ODI score below 20 or above 90; 6. Degenerative intervertebral disc with severe endlaminitis, Modic III changes on MRI images; 7. Lumbar disc herniation clearly compresses nerve roots and radiates pain in the lower limbs; 8. low back pain caused by lumbar lumbar segmental instability, lumbar spinal stenosis, lumbar arthropathy facet joint osteoarthritis, lumbar back myofascitis, acute and chronic thoracolumbar fracture; 9. Various congenital and acquired scoliosis and other spine malformations; 10. There was a history of intraspinal steroid injection within 3 months prior to trial initiation; 11. Abnormal coagulation function, international normalized ratio (INR) >1.5; 12. Severe hepatic and renal insufficiency; 13. Overweight (obesity Class II) with a body mass index greater than 35; 14. Pregnant or lactating women; 15. Patients with malignant tumors; 16. Patients who are receiving immunosuppressants; 17. Patients with spinal infections; 18. Patients who had received stem cell therapy within six months prior to study; 19. The degraded disc segment has previously undergone surgical treatment, including nucleus pulposus extraction, radiofrequency ablation, etc; 20. Other conditions that may hinder participation in the study according to medical standards;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events;Low back pain improvement (VAS score);Lumbar functional recovery (ODI score); | — |
Secondary
| Measure | Time frame |
|---|---|
| Test including blood routine, liver and kidney function, tumor four, coagulation function;Pfirrmann rating by MRI; | — |
Countries
China
Contacts
Public ContactXialin Li
Huazhong University of Science and Technology Union Shenzhen Hospital
Outcome results
None listed