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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai General Hospital
Shanghai, China
RECRUITINGLumbar disc signaling values from magnetic resonance imaging
Changes from baseline in Lumbar disc signaling values from magnetic resonance imaging
Time frame: Baseline, post-op 3months, post-op 6months, post-op 12months
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
Time frame: 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
Time frame: 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)
Time frame: Baseline, post-op 3months, post-op 6months, post-op 12months
Disc Height Index (DHI) from X ray
Changes from baseline in Disc Height Index
Time frame: 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
Time frame: 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.
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Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months