Clinical trial NCT04414592: Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease
Official title: Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Degeneration
Lumbar Disc Herniation
Keywords: Lumbar Disc Degeneration
Human Umbilical Cord Mesenchymal Stem Cells
Lumbar Disc Herniation
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 degenerative disc leads to symptoms relief and slow down the progression of disc degeneration.

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 endoscopic discectomy has been widely used in the treatment of lumbar disc herniation due to its advantages of reduced trauma, enhanced recovery and less cost. However, the reherniation of the residual nucleus pulposus still exist after nerve root decompression. It is urgent to use stem cell and tissue engineering to replace the resection tissue and repair the residual nucleus pulposus for disc resealing. To observe the safety and efficacy of human umbilical cord mesenchymal stem cells (hUCMSCs) in the treatment of lumbar disc degeneration. This clinical trial is aimed to include a single group of 20 patients with lumbar disc herniation. Twenty million hUCMSCs will be injected into the lumbar disc of the enrolled patients in this non-random, self-controlled and single-dose open study design. The patients will be followed up for 3 months, 6 months and 12 months after the injection to evaluate the safety of the patients after grafting hUCMSCs. Additionally, improvement of patients' quality of life will be evaluated using the ODI score, VAS score and SF-36 score. Lumbar disc signals will be also quantified using MRI to demonstrate hUCMSCs transplantation could slow down lumbar disc degeneration.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-60 years old;
2. Symptoms with lower back pain and unilateral radicular pain;
3. Failure of conservative treatments including physical therapy, manipulation therapy and non-morphine drug therapy;
4. CT/MRI clearly showing unilateral nucleus pulposus herniation to compress the nerve root;
5. Symptoms and imaging showing unilateral lumbar disc herniation;
6. Imaging showed single-segment lumbar disc herniation;
7. Pfirrmann disc degeneration classification from lumbar MRI: grade I-IV;
8. Segments of lumbar disc herniation: L3-4, L4-5, L5-S1;
9. Unilateral full endoscopic lumbar discectomy;
10. Signing the informed consent;
11. No previous history of spinal surgery.

Exclusion Criteria:

1. Previous history of tumor or spinal infection;
2. Severe coagulation disorders or are taking oral anticoagulants
3. coma or incapacity;
4. MRI contraindications (cardiovascular and cerebrovascular stent implantation history, cardiac pacemaker, biological stimulator, etc.);
5. pregnant;
6. pregnancy or breastfeeding;
7. participated in other clinical trials in the past 30 days;
8. History of stem cell therapy;
9. poor compliance, or inability to properly understand the coordination;
10. received intervertebral disc interventional therapy, such as radiofrequency, laser ablation, protease injection and ozone injection in the past 3 months;
11. Highly allergic constitution or severe allergic history;
12. Severe autoimmune diseases or receiving immunosuppressive therapy;
13. Severe infection or high fever;
14. Shock, failure of vital organs or unstable vital signs;
15. X-ray showing that the stenosis percentage of the degenerative segment was larger than 30% compared to that of the adjacent normal segment.
16. Lumbar disc herniation with calcification;
17. Lumbar disc herniation with Modic Change;
18. Lumbar disc herniation with severe spinal stenosis;
19. Lumbar disc herniation with lumbar spondylolisthesis;
20. Lumbar disc herniation with spinal deformity;
21. psychosocial abnormalities, cognitive impairment, or other physical diseases affecting the research results;
22. Other reasons.

Primary outcomes:
measure: Lumbar disc signaling values from magnetic resonance imaging
timeFrame: Baseline, post-op 3months, post-op 6months, post-op 12months
Secondary outcomes:
measure: Visual Analogue Scale (VAS) (0-10 scores, the higher scores mean a worse outcome)
timeFrame: Baseline, post-op 3months, post-op 6months, post-op 12months
measure: Oswestry Disability Index(ODI) (0-50 scores, the higher scores mean a worse outcome)
timeFrame: Baseline, post-op 3months, post-op 6months, post-op 12months
measure: The Short Form (36) Health survey (SF36) (0-100 scores, the higher scores mean a better outcome)
timeFrame: Baseline, post-op 3months, post-op 6months, post-op 12months
measure: Disc Height Index (DHI) from X ray
timeFrame: Baseline, post-op 3months, post-op 6months, post-op 12months
measure: Size of herniated nucleus pulposus from magnetic resonance imaging
timeFrame: Baseline, post-op 3months, post-op 6months, post-op 12months
measure: Number of participants with treatment-related adverse events by CTCAE v4.0
timeFrame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
affiliation: Minimally Invasive Spinal of Shanghai General Hospital
name: Qiang Fu, M.D.
role: PRINCIPAL_INVESTIGATOR
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