<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03002207</url>
  </required_header>
  <id_info>
    <org_study_id>2016(001)</org_study_id>
    <nct_id>NCT03002207</nct_id>
  </id_info>
  <brief_title>Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation</brief_title>
  <official_title>A Prospective, Comparative Study to Evaluate Effectiveness of Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhanghao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this prospective study the investigators seek to evaluate clinical outcomes after&#xD;
      repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during&#xD;
      microendoscopic discectomy for participants of lumbar disc herniation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants with lumbar disc herniation diseases are treated by Microendoscopic&#xD;
      discectomy, and they are divided into four groups depend on whether the defect is repaired&#xD;
      with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is&#xD;
      sutured or not. In the first group,the defect of intervertebral disc is repaired with&#xD;
      Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured. In the second group, the&#xD;
      defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell&#xD;
      (BMSC)/gelatin sponge but not sutured after discectomy. In the third group, the defect of&#xD;
      intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell&#xD;
      (BMSC)/gelatin sponge after discectomy. In the four group, the defect of intervertebral disc&#xD;
      is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge&#xD;
      after discectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in Oswestry Disability Index(ODI)</measure>
    <time_frame>Baseline, post-op 3 months, 6 months,12 months</time_frame>
    <description>The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in Visual Analogue Scale(VAS)</measure>
    <time_frame>Baseline, post-op 3 months, 6 months,12 months</time_frame>
    <description>Self reported pain using a 10-point visual analogue scale (0=no pain;10=pain as bad as can be)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in The Short Form (36) Health Survey(SF-36)</measure>
    <time_frame>Baseline, post-op 3 months, 6 months,12 months</time_frame>
    <description>The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）</measure>
    <time_frame>Baseline, post-op 12 months</time_frame>
    <description>The Pfirrmann grading system assesses degenerated intervertebral discs by MRI for the asymmetry in disc structure, distinction of the nucleus and the annulus, signal intensity of intervertebral discs and height of intervertebral discs and assigns grade I to V for disc degeneration。</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in The Height of Disc on MRI Scans</measure>
    <time_frame>Baseline, post-op 12 months</time_frame>
    <description>Using imaging software, physicians will measure disc height at the treatment discs on the midline T1 sagittal view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in The Size of Disc Protrusion</measure>
    <time_frame>Baseline, post-op 12 months</time_frame>
    <description>We will measure the anteroposterior (AP) size of the disc protrusions that required treatment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Medical Records</measure>
    <time_frame>1 months after hospital discharge</time_frame>
    <description>The Medical Records including operative time、blood loss and hospital stay</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Lumbar Disc Herniation</condition>
  <arm_group>
    <arm_group_label>The defect is repaired and sutured</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The defect is repaired but not sutured</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The defect is sutured but not repaired</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The defect is neither sutured nor repaired</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the four group, the defect of intervertebral disc is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge</intervention_name>
    <description>Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.</description>
    <arm_group_label>The defect is repaired and sutured</arm_group_label>
    <arm_group_label>The defect is repaired but not sutured</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The defect is sutured</intervention_name>
    <description>Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.</description>
    <arm_group_label>The defect is repaired and sutured</arm_group_label>
    <arm_group_label>The defect is sutured but not repaired</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants with signs and symptoms of lumbar disc herniation requiring surgical&#xD;
             treatment after conservative management;&#xD;
&#xD;
          2. Radiological data on CT/MRI obtained within a period prior to enrollment;&#xD;
&#xD;
          3. Participants give written informed consent before enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. If participants had an incomplete medical record;&#xD;
&#xD;
          2. Participants had spine tumor, spine infection, previous underwent lumbar surgery, or&#xD;
             revision surgery.&#xD;
&#xD;
          3. Participants are taking uninterruptible anticoagulation therapy.&#xD;
&#xD;
          4. Dementia and/or inability to give informed consent.&#xD;
&#xD;
          5. MRI contraindication (e.g. cerebral aneurysm clips, cochlear implants, pacemaker,&#xD;
             implanted biostimulators);&#xD;
&#xD;
          6. Pregnancy;&#xD;
&#xD;
          7. Participation in other clinical trial within the last 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinlong Ma</last_name>
    <role>Study Chair</role>
    <affiliation>Tianjin Hospital Of Tianjin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Baoshan Xu</last_name>
    <phone>86-13502028198</phone>
    <email>xubaoshan99@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yue Liu</last_name>
    <phone>86-13652006399</phone>
    <email>yourliuyue@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tianjin Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300211</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Baoshan Xu</last_name>
      <phone>86-13502028198</phone>
      <email>xubaoshan99@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Yue Liu</last_name>
      <phone>86-13652006399</phone>
      <email>yourliuyue@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Kaihui Zhang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sakai D, Andersson GB. Stem cell therapy for intervertebral disc regeneration: obstacles and solutions. Nat Rev Rheumatol. 2015 Apr;11(4):243-56. doi: 10.1038/nrrheum.2015.13. Epub 2015 Feb 24.</citation>
    <PMID>25708497</PMID>
  </reference>
  <reference>
    <citation>Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845.</citation>
    <PMID>25187512</PMID>
  </reference>
  <reference>
    <citation>Hernigou P, Poignard A, Beaujean F, Rouard H. Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005 Jul;87(7):1430-7. doi: 10.2106/JBJS.D.02215.</citation>
    <PMID>15995108</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin Hospital</investigator_affiliation>
    <investigator_full_name>Zhanghao</investigator_full_name>
    <investigator_title>Tianjin Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03002207
org study id: 2016(001)
nct id: NCT03002207
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this prospective study the investigators seek to evaluate clinical outcomes after
      repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during
      microendoscopic discectomy for participants of lumbar disc herniation.
The participants with lumbar disc herniation diseases are treated by Microendoscopic
      discectomy, and they are divided into four groups depend on whether the defect is repaired
      with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is
      sutured or not. In the first group,the defect of intervertebral disc is repaired with
      Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured. In the second group, the
      defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell
      (BMSC)/gelatin sponge but not sutured after discectomy. In the third group, the defect of
      intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell
      (BMSC)/gelatin sponge after discectomy. In the four group, the defect of intervertebral disc
      is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge
      after discectomy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes from baseline in Oswestry Disability Index(ODI)
time frame: Baseline, post-op 3 months, 6 months,12 months
description: The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
measure: Changes from baseline in Visual Analogue Scale(VAS)
time frame: Baseline, post-op 3 months, 6 months,12 months
description: Self reported pain using a 10-point visual analogue scale (0=no pain;10=pain as bad as can be)
measure: Changes from baseline in The Short Form (36) Health Survey(SF-36)
time frame: Baseline, post-op 3 months, 6 months,12 months
description: The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
measure: Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）
time frame: Baseline, post-op 12 months
description: The Pfirrmann grading system assesses degenerated intervertebral discs by MRI for the asymmetry in disc structure, distinction of the nucleus and the annulus, signal intensity of intervertebral discs and height of intervertebral discs and assigns grade I to V for disc degeneration。
measure: Change from Baseline in The Height of Disc on MRI Scans
time frame: Baseline, post-op 12 months
description: Using imaging software, physicians will measure disc height at the treatment discs on the midline T1 sagittal view
measure: Change from Baseline in The Size of Disc Protrusion
time frame: Baseline, post-op 12 months
description: We will measure the anteroposterior (AP) size of the disc protrusions that required treatment
measure: The Medical Records
time frame: 1 months after hospital discharge
description: The Medical Records including operative time、blood loss and hospital stay
arm group label: The defect is repaired and sutured
arm group type: Experimental
description: Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured.
arm group label: The defect is repaired but not sutured
arm group type: Experimental
description: Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy.
arm group label: The defect is sutured but not repaired
arm group type: Experimental
description: Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
arm group label: The defect is neither sutured nor repaired
arm group type: No Intervention
description: Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the four group, the defect of intervertebral disc is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
intervention type: Device
intervention name: Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge
description: Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
arm group label: The defect is repaired and sutured
arm group label: The defect is repaired but not sutured
intervention type: Procedure
intervention name: The defect is sutured
description: Participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and the defect is sutured after discectomy.
arm group label: The defect is repaired and sutured
arm group label: The defect is sutured but not repaired
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Xinlong Ma
role: Study Chair
affiliation: Tianjin Hospital Of Tianjin
last name: Baoshan Xu
phone: 86-13502028198
email: xubaoshan99@126.com
last name: Yue Liu
phone: 86-13652006399
email: yourliuyue@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
citation: Sakai D, Andersson GB. Stem cell therapy for intervertebral disc regeneration: obstacles and solutions. Nat Rev Rheumatol. 2015 Apr;11(4):243-56. doi: 10.1038/nrrheum.2015.13. Epub 2015 Feb 24.
PMID: 25708497
citation: Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845.
PMID: 25187512
citation: Hernigou P, Poignard A, Beaujean F, Rouard H. Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005 Jul;87(7):1430-7. doi: 10.2106/JBJS.D.02215.
PMID: 15995108
responsible party type: Sponsor-Investigator
investigator affiliation: Tianjin Hospital
investigator full name: Zhanghao
investigator title: Tianjin Hospital
mesh term: Intervertebral Disc Displacement
mesh term: Hernia
sharing ipd: No