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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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Updated on 16 February 2024
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back pain
discectomy
conservative management
radicular pain
spinal surgery
morphine
manipulative therapy
lumbar disc herniation
lumbar disc degeneration

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.

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.

Details
Condition Lumbar Disc Herniation, Lumbar Disc Degeneration
Age 18years - 60years
Treatment human umbilical cord mesenchymal stem cells
Clinical Study IdentifierNCT04414592
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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