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

Primary Purpose

Lumbar Disc Degeneration, Lumbar Disc Herniation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

human umbilical cord mesenchymal stem cells

About this trial

This is an interventional treatment trial for Lumbar Disc Degeneration focused on measuring Lumbar Disc Degeneration, Human Umbilical Cord Mesenchymal Stem Cells, Lumbar Disc Herniation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai General HospitalRecruiting
Shanghai General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human Umbilical Cord Mesenchymal Stem Cells

Arm Description

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

Outcomes

Primary Outcome Measures

Lumbar disc signaling values from magnetic resonance imaging

Changes from baseline in Lumbar disc signaling values from magnetic resonance imaging

Secondary Outcome Measures

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

Oswestry Disability Index(ODI) (0-50 scores, the higher scores mean a worse outcome)

Changes from baseline in Oswestry Disability Index

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)

Disc Height Index (DHI) from X ray

Changes from baseline in Disc Height Index

Size of herniated nucleus pulposus from magnetic resonance imaging

Changes from baseline in size of nucleus pulposus from magnetic resonance imaging

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.

Full Information

NCT ID

NCT04414592

First Posted

May 6, 2020

Last Updated

May 31, 2020

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04414592

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 2020 (Anticipated)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Disc Degeneration, Lumbar Disc Herniation

Keywords

Lumbar Disc Degeneration, Human Umbilical Cord Mesenchymal Stem Cells, Lumbar Disc Herniation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Human Umbilical Cord Mesenchymal Stem Cells

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

human umbilical cord mesenchymal stem cells

Intervention Description

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 Measure Information:

Title

Lumbar disc signaling values from magnetic resonance imaging

Description

Changes from baseline in Lumbar disc signaling values from magnetic resonance imaging

Time Frame

Baseline, post-op 3months, post-op 6months, post-op 12months

Secondary Outcome Measure Information:

Title

Visual Analogue Scale (VAS) (0-10 scores, the higher scores mean a worse outcome)

Description

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

Title

Oswestry Disability Index(ODI) (0-50 scores, the higher scores mean a worse outcome)

Description

Changes from baseline in Oswestry Disability Index

Time Frame

Baseline, post-op 3months, post-op 6months, post-op 12months

Title

The Short Form (36) Health survey (SF36) (0-100 scores, the higher scores mean a better outcome)

Description

Changes from baseline in The Short Form (36) Health survey (SF36)

Time Frame

Baseline, post-op 3months, post-op 6months, post-op 12months

Title

Disc Height Index (DHI) from X ray

Description

Changes from baseline in Disc Height Index

Time Frame

Baseline, post-op 3months, post-op 6months, post-op 12months

Title

Size of herniated nucleus pulposus from magnetic resonance imaging

Description

Changes from baseline in size of nucleus pulposus from magnetic resonance imaging

Time Frame

Baseline, post-op 3months, post-op 6months, post-op 12months

Title

Number of participants with treatment-related adverse events by CTCAE v4.0

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Song Guo, M.D.

Phone

15901836457

guosongtj@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jigang Zhang, M.D.

Phone

18621155781

2293259778@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiang Fu, M.D.

Organizational Affiliation

Minimally Invasive Spinal of Shanghai General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai General Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qiang Fu, M.D.

Phone

13636636288

johson.f@163.com

First Name & Middle Initial & Last Name & Degree

Song Guo, M.D.

Phone

15901836457

guosongtj@163.com

First Name & Middle Initial & Last Name & Degree

Qiang Fu, M.D.

Facility Name

Shanghai General Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qiang Fu, M.D.

Phone

13636636288

First Name & Middle Initial & Last Name & Degree

Qiang Fu, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

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

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