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

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ClinicalTrials.gov Identifier: NCT04414592
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Qiang Fu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Degeneration Lumbar Disc Herniation Other: human umbilical cord mesenchymal stem cells Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Human Umbilical Cord Mesenchymal Stem Cells
Injection of twenty million human umbilical cord mesenchymal stem cells into the degenerative disc
Other: human umbilical cord mesenchymal stem cells
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.




Primary Outcome Measures :
  1. Lumbar disc signaling values from magnetic resonance imaging [ Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months ]
    Changes from baseline in Lumbar disc signaling values from magnetic resonance imaging


Secondary Outcome Measures :
  1. Visual Analogue Scale (VAS) (0-10 scores, the higher scores mean a worse outcome) [ Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months ]
    Changes from baseline in Visual Analogue Scale of Lower back pain and leg pain

  2. Oswestry Disability Index(ODI) (0-50 scores, the higher scores mean a worse outcome) [ Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months ]
    Changes from baseline in Oswestry Disability Index

  3. The Short Form (36) Health survey (SF36) (0-100 scores, the higher scores mean a better outcome) [ Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months ]
    Changes from baseline in The Short Form (36) Health survey (SF36)

  4. Disc Height Index (DHI) from X ray [ Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months ]
    Changes from baseline in Disc Height Index

  5. Size of herniated nucleus pulposus from magnetic resonance imaging [ Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months ]
    Changes from baseline in size of nucleus pulposus from magnetic resonance imaging

  6. Number of participants with treatment-related adverse events by CTCAE v4.0 [ 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 ]
    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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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414592


Contacts
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Contact: Song Guo, M.D. 15901836457 guosongtj@163.com
Contact: Jigang Zhang, M.D. 18621155781 2293259778@qq.com

Locations
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China, Shanghai
Shanghai General Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Qiang Fu, M.D.    13636636288    johson.f@163.com   
Contact: Song Guo, M.D.    15901836457    guosongtj@163.com   
Principal Investigator: Qiang Fu, M.D.         
China
Shanghai General Hospital Recruiting
Shanghai, China
Contact: Qiang Fu, M.D.    13636636288      
Principal Investigator: Qiang Fu, M.D.         
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Qiang Fu, M.D. Minimally Invasive Spinal of Shanghai General Hospital
Publications:

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Responsible Party: Qiang Fu, Dean of the Minimally Invisive Spine Surgery Department, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04414592    
Other Study ID Numbers: QFu
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the relative individual participant data (IPD) collected during the trial after deidentification
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Immediately following publication. No end date.
Access Criteria: The researchers associate with disc degeneration and stem cells.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qiang Fu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Lumbar Disc Degeneration
Human Umbilical Cord Mesenchymal Stem Cells
Lumbar Disc Herniation
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Hernia
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases