Status:
UNKNOWN
Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Lumbar Disc Degeneration
Lumbar Disc Herniation
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study aims to investigate the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (hUCMSC) for treating lumbar disc degeneration diseases. We hypothesize grafting hUCMSC into the...
Detailed Description
Lumbar disc herniation causes patients severe lower back pain and radicular pain to decrease the quality of life and lead to great economic burden to patients and society. In recent years, full endosc...
Eligibility Criteria
Inclusion
- Age: 18-60 years old;
- Symptoms with lower back pain and unilateral radicular pain;
- Failure of conservative treatments including physical therapy, manipulation therapy and non-morphine drug therapy;
- CT/MRI clearly showing unilateral nucleus pulposus herniation to compress the nerve root;
- Symptoms and imaging showing unilateral lumbar disc herniation;
- Imaging showed single-segment lumbar disc herniation;
- Pfirrmann disc degeneration classification from lumbar MRI: grade I-IV;
- Segments of lumbar disc herniation: L3-4, L4-5, L5-S1;
- Unilateral full endoscopic lumbar discectomy;
- Signing the informed consent;
- No previous history of spinal surgery.
Exclusion
- Previous history of tumor or spinal infection;
- Severe coagulation disorders or are taking oral anticoagulants
- coma or incapacity;
- MRI contraindications (cardiovascular and cerebrovascular stent implantation history, cardiac pacemaker, biological stimulator, etc.);
- pregnant;
- pregnancy or breastfeeding;
- participated in other clinical trials in the past 30 days;
- History of stem cell therapy;
- poor compliance, or inability to properly understand the coordination;
- received intervertebral disc interventional therapy, such as radiofrequency, laser ablation, protease injection and ozone injection in the past 3 months;
- Highly allergic constitution or severe allergic history;
- Severe autoimmune diseases or receiving immunosuppressive therapy;
- Severe infection or high fever;
- Shock, failure of vital organs or unstable vital signs;
- X-ray showing that the stenosis percentage of the degenerative segment was larger than 30% compared to that of the adjacent normal segment.
- Lumbar disc herniation with calcification;
- Lumbar disc herniation with Modic Change;
- Lumbar disc herniation with severe spinal stenosis;
- Lumbar disc herniation with lumbar spondylolisthesis;
- Lumbar disc herniation with spinal deformity;
- psychosocial abnormalities, cognitive impairment, or other physical diseases affecting the research results;
- Other reasons.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04414592
Start Date
August 1 2020
End Date
March 1 2023
Last Update
June 4 2020
Active Locations (2)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
2
Shanghai General Hospital
Shanghai, China