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

NCT ID: NCT04414592

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2023-03-31

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.

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.

Conditions

Lumbar Disc Degeneration; Lumbar Disc Herniation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human Umbilical Cord Mesenchymal Stem Cells

Injection of twenty million human umbilical cord mesenchymal stem cells into the degenerative disc

Group Type: EXPERIMENTAL

human umbilical cord mesenchymal stem cells

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Qiang Fu

Dean of the Minimally Invisive Spine Surgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiang Fu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Minimally Invasive Spinal of Shanghai General Hospital

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Shanghai General Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Song Guo, M.D.

Role: CONTACT

guosongtj@163.com

15901836457

Jigang Zhang, M.D.

Role: CONTACT

2293259778@qq.com

18621155781

Facility Contacts

Qiang Fu, M.D.

Role: primary

johson.f@163.com

13636636288

Song Guo, M.D.

Role: backup

guosongtj@163.com

15901836457

Qiang Fu, M.D.

Role: primary

13636636288

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Other Identifiers

QFu

Identifier Type: -

Identifier Source: org_study_id