Discogenic low back pain
Conditions
Interventions
The high-dose group:1 ml autologous adipose mesenchymal stem cell suspension (20 million cells/disc) and 1 ml Tissuefill (1% concentration) were injected
The mid-dose group:0.5ml autologous adipose mesenchymal stem cell suspension (10 million cells/disc) was injected with 0.5ml normal saline and 1 ml Tissuefill (concentration 1%)
The low-dose group:0.25ml autologous adipose mesenchymal stem cell suspension (5 million cells/disc), 0.75ml normal saline, and 1 ml Tissuefill (1% concentration) were injected
The control group:2ml of normal saline
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. No gender restriction, aged >= 18 years; 2. Chronic low back pain is accompanied by two or more clinical manifestations: increased abdominal pressure such as cough and sneeze, increased pain when sitting for a long time, forward bending or lifting heavy objects, difficult to relieve or unable to maintain the same posture, pain relief when lying flat; 3. For patients with chronic low back pain, the symptoms still recurred after more than 3 months of conservative treatment; 4. Pain simulation score (VAS) >=4 points; 5. Oswestry Disability Index (ODI) >= 30%; 6. MRI showed that the cartilaginous endplate of the intervertebral disc at L4-5 segments was Modic type I or II; 7. MRI showed that the Pfirrmann grading of L4-5 intervertebral discs was grade 3, 4, or 5; 8. In the discography examination of the degenerated lumbar intervertebral disc determined by MRI, the patient only had one intervertebral disc with similar pain degree as usual at L4-5 segments; 9. X-rays showed that the lumbar disc height was reduced by more than 20% compared to the adjacent normal disc; 10. Patients without active infections (such as HBsAg, HIV, CMV and rubella virus).
Exclusion criteria
Exclusion criteria: 1. Patients with spondylitis or vertebral fracture; 2. Patients with severe lumbar spinal stenosis or lumbar nucleus pulposus prolapse resulting in severe nerve compression and lower extremity pain requiring surgical treatment; 3. Patients who have received any intramuscular injection (e.g. intramuscular injection of corticosteroids, methylene blue, glucose or glucosamine, and chondroitin sulfate) in the three months prior to the transplant; 4. X-ray examination in dynamic position of the lumbar spine showed adjacent vertebral slippage > 3mm or angulation > 15 degree; 5. Bone mineral density (BMD) T-value was -2.5 or lower by dual-energy X-ray absorptiometry (DEXA); 6. Pregnant or lactating patients, or patients who became pregnant within 24 months of receiving transplant treatment; 7. Patients suffering from mental illness or drug or alcohol abuse or inability to understand the purpose or methodology of the study; 8. Patients with a history of multiple systemic diseases such as cancer, autoimmune diseases, blood diseases, kidney or liver diseases; 9. Patients who are allergic to hyaluronic acid, contrast agents or local anesthetics (e.g. lidocaine, bupivacaine); 10. Patients who have used any other cell products and/or plan to participate in any other stem cell clinical trials during the 2-year follow-up period following transplant therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oswestry dability index;Japanese orthopaedic association scores system;SF-36 health scale;Intervertebral disc Modic typing;Pfirrmann grading of intervertebral disc;Intervertebral disc height;Segment range of motion;Vital signs (temperature, pulse, respiration, blood pressure);Blood routine;Liver and kidney function;Immunological examination;Urinalysis;Treatment emergent adverse event; | — |
Countries
China
Contacts
Public ContactLi Zhonghai
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed