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

May 31, 2020 updated by: Qiang Fu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai General Hospital
        • Principal Investigator:
          • Qiang Fu, M.D.
        • Contact:
          • Qiang Fu, M.D.
          • Phone Number: 13636636288
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qiang Fu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
Baseline, post-op 3months, post-op 6months, post-op 12months
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
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)
Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months
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
Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months
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
Time Frame: Baseline, post-op 3months, post-op 6months, post-op 12months
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
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.
From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Qiang Fu, M.D., Minimally Invasive Spinal of Shanghai General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2020

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 31, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 31, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QFu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the relative individual participant data (IPD) collected during the trial after deidentification

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

The researchers associate with disc degeneration and stem cells.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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