Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease

Conditions
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Lumbar Disc Degeneration, Lumbar Disc Herniation

Intervention / Treatment
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* Other: human umbilical cord mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Umbilical Cord Mesenchymal Stem Cells<br>Injection of twenty million human umbilical cord mesenchymal stem cells into the degenerative disc | Other: human umbilical cord mesenchymal stem cells<br>* Twenty million human umbilical cord mesenchymal stem cells will be immediately injected into the degenerative discs of such patients who are diagnosed with lumbar disc herniation and operated with full endoscopy lumbar discectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar disc signaling values from magnetic resonance imaging | Changes from baseline in Lumbar disc signaling values from magnetic resonance imaging | Baseline, post-op 3months, post-op 6months, post-op 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) (0-10 scores, the higher scores mean a worse outcome) | Changes from baseline in Visual Analogue Scale of Lower back pain and leg pain | Baseline, post-op 3months, post-op 6months, post-op 12months | 
| Oswestry Disability Index(ODI) (0-50 scores, the higher scores mean a worse outcome) | Changes from baseline in Oswestry Disability Index | Baseline, post-op 3months, post-op 6months, post-op 12months | 
| The Short Form (36) Health survey (SF36) (0-100 scores, the higher scores mean a better outcome) | Changes from baseline in The Short Form (36) Health survey (SF36) | Baseline, post-op 3months, post-op 6months, post-op 12months | 
| Disc Height Index (DHI) from X ray | Changes from baseline in Disc Height Index | Baseline, post-op 3months, post-op 6months, post-op 12months | 
| Size of herniated nucleus pulposus from magnetic resonance imaging | Changes from baseline in size of nucleus pulposus from magnetic resonance imaging | Baseline, post-op 3months, post-op 6months, post-op 12months | 
| Number of participants with treatment-related adverse events by CTCAE v4.0 | Assessing for worsening of patients' baseline symptoms or functions (will be considered an AE); (also general AE events), particular AE events related to the procedures/treatment. All AEs will be assessed by common terminology criteria for adverse events. | From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Disc Degeneration, Human Umbilical Cord Mesenchymal Stem Cells, Lumbar Disc Herniation