Discogenic low back pain
Conditions
Interventions
Stem cell treatment group:Human umbilical cord mesenchymal stem cells injection
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who are male or female and whose age must be 18 years old or older. 2. Chronic LBP is accompanied by more than two (including two) clinical manifestations: increased pain when abdominal pressure increases such as cough and sneezing, increased pain when sedentary, forward bending or lifting heavy objects, difficult to relieve or unable to maintain the same posture, and pain relief when lying flat and resting. 3. Patients with LBP lasting 3 months or longer after conservative treatment. 4. Visual analogue scale of 4 or higher. 5. Oswestry disability index of 30% or higher. 6. MRI shows that the CEPs of the L4-5 IVD is Modic type I or II; 7. MRI shows that the L4-5 IVD is Pfirrmann grade 3, 4 or 5; 8. Discography of lumbar IVD(s) identified as degenerated by MRI show(s) that the patients have only one disc of L4-5 level with similar pain as usual. 9. Patients with =20% loss of lumbar disc height compared to normal adjacent discs based on X-ray assessment. 10. Patients with no active infection (such as HBsAg, HIV, CMV and rubella virus).
Exclusion criteria
Exclusion criteria: 1. Patients with spondylitis or vertebral fractures. 2. Surgery is required for patients with severe lumbar spinal stenosis or prolapse of the lumbar nucleus pulposus resulting in severe nerve compression and pain in the lower limbs. 3. Patients who have received any intradiscal injection procedure (eg, injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate) within the three months prior to receiving transplantation therapy. 4. Dynamic X-ray examination of the lumbar spine shows that the adjacent vertebral body slips > 3 mm or is angled > 15°. 5. Patients with severe osteoporosis with a bone mineral density (BMD) T value of -2.5 or lower on dual energy X-ray absorptiometry (DEXA). 6. Pregnant or lactating women, or women who become pregnant within 24 months after receiving intervention. 7. Patients with mental illness or drug addictions or alcohol addictions or those incapable of understanding the purpose or methods of the study. 8. Patients with a history of various systemic diseases such as cancer, autoimmune disease, blood diseases, kidney diseases, and liver diseases. 9. Patients who are allergic to contrast agents or local anesthetics (eg, lidocaine, bupivacaine). 10. Patients who have previously used any other cell product and/or plan to participate in any other stem cell clinical trial during the 2-year follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oswestry dability index;Japanese orthopaedic association scores system;The Mos 36-item short form health survey score;The Modic changes of the IVD;Intervertebral disc height;Segment range of motion;Vital signs:(body temperature, pulse, respiration, blood pressure);Blood routine;Liver and kidney function;Immunological examination;Urinalysis;The Pfirrmann grade of the IVD;Adverse Events and Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactZhonghai Li
Outcome results
None listed