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

NCT04414592 | Unknown DMC

• 1 other identifier: QFu
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Lumbar Disc Degeneration; Lumbar Disc Herniation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Lumbar disc signaling values from magnetic resonance imaging

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

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

Secondary Outcomes (6)

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

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

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

  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)

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

• Disc Height Index (DHI) from X ray

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

• Size of herniated nucleus pulposus from magnetic resonance imaging

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

Study Arms (1)

Human Umbilical Cord Mesenchymal Stem Cells

EXPERIMENTAL

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

Other: human umbilical cord mesenchymal stem cells

Interventions

human umbilical cord mesenchymal stem cells 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.

Human Umbilical Cord Mesenchymal Stem Cells

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (2)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Shanghai General Hospital

Shanghai, China

RECRUITING

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MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiang Fu, M.D.

  Minimally Invasive Spinal of Shanghai General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Guo, M.D.

CONTACT

15901836457; guosongtj@163.com

Jigang Zhang, M.D.

CONTACT

18621155781; 2293259778@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the Minimally Invisive Spine Surgery Department

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: June 4, 2020
• Study Start: August 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: The researchers associate with disc degeneration and stem cells.

Locations

CN (2)