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Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease (AMSC-DSD-001)

Primary Purpose

Degenerative Disc Disease

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Suspension of human autologous MSC 3P in 1.5 ml
Sponsored by
Bioinova, s.r.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,
  2. patients indicated for fusion therapy,
  3. patients between 18-55 years, both sexes,
  4. patients able to provide written informed consent.

Exclusion Criteria:

  1. previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion,
  2. osteoporosis,
  3. diabetes mellitus,
  4. pregnancy or breastfeeding,
  5. women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
  6. fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube),
  7. coagulopathy,
  8. malnutrition, primary biliary cirrhosis,
  9. skin infection at the site of bone marrow aspiration or at the site of spinal fusion,
  10. gastrostomy,
  11. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, recurrent thromboembolic disease .....),
  12. alcohol or drug abuse,
  13. cancer (compulsory clinical oncological screening),
  14. ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Human AMSC (passage 3) 3P in 1.5 mL

    Arm Description

    Patient receiving the investigational medicinal product - suspension of human autologous MSC 3P in 1.5 mL

    Outcomes

    Primary Outcome Measures

    Safety: To demonstrate absence of complications at the site of spinal fusion
    Complications at the site of spinal fusion and other treatment-related adverse events will be recorded in ten patients at Visits I through VII. All adverse events (AEs) will be classified by seriousness, severity and relationship to hAMSC application. All AEs will be collected as symptoms spontaneously reported by the patient, clinically relevant changes and abnormalities observed by the Investigator (clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations) Intensity The following 3-point rating scale will be used for rating of the intensity of each AE: Mild: Awareness of signs or symptoms, but no disruption of usual activity Moderate: Event sufficient to affect usual activities (disturbing) Severe: Inability to work or perform usual activities (unacceptable)

    Secondary Outcome Measures

    Efficacy: To assess the quality of life determined by Oswestry Questionnaire.
    The quality of life determined by Oswestry Questionnaire will be recorded in ten patients at Visits II, and IV through VII. The test has 10 sections and maximum score is 50 points; change from the baseline valie will be recorded. The points are then transferred into percentage and interpreted in a standard way when 0-20% means minimal disability while 81-100% means bed-bound condition. Minimum detectable change (90 % confidence) is 10 % (5 points).
    Efficacy: To assess the quality of spinal fusion by X-ray imaging
    The quality of spinal fusion will be measured by X-ray imaging at Visits V and VII. Dynamic X-ray of the lumbar spine will be performed at 3 and 12 months following the surgery and hAMSC application to measure the angle of the spine movement in the fusion area. The angle will be recorded in degrees. The movements above 10 degrees will beregarded as "unstable". The bone fusion morphology will be evaluated based on the following scale: Cyst or pseudo-cyst formation Fusion not visible Pseudo-joint (or false joint) development Low degree of bone fusion High degree of bone fusion
    Efficacy: To assess the quality of spinal fusion measured by computed tomography (CT).
    The quality of spinal fusion will be measured by CT in ten patients at Visits V and VII. The density will of the fusion will be expressed as % on a linear scale between two standardized measuring points: soft tissue= 0%, vertebral arch= 100%.

    Full Information

    First Posted
    January 14, 2019
    Last Updated
    January 14, 2020
    Sponsor
    Bioinova, s.r.o.
    Collaborators
    Department of Spine Surgery, University Hospital Motol, Prague, Czech Republilc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03827096
    Brief Title
    Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease
    Acronym
    AMSC-DSD-001
    Official Title
    Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease to Assess the Safety and the Efficacy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    Primary endpoint (Safety) has been achieved
    Study Start Date
    August 27, 2013 (Actual)
    Primary Completion Date
    December 14, 2016 (Actual)
    Study Completion Date
    December 14, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bioinova, s.r.o.
    Collaborators
    Department of Spine Surgery, University Hospital Motol, Prague, Czech Republilc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. After the surgery, the subjects were followed up as out-patients during 5 study visits for 12 months in total.
    Detailed Description
    Following informed consent collection at the screening visit and verification of all inclusion and exclusion criteria, eligible patients will undergo the procedure of bone marrow cell aspiration from iliac crest for the purpose of receiving autologous multipotent mesenchymal stem cells. The cells will be cultivated for 3 passages (for 3 - 4 weeks) in order to expand them to sufficient quantity. Suspension of the cultured AMSC will then be sterilely packed and transported to the surgery site. During the posterolateral spine fusion operation, 1.5 ml of cell suspension will be mixed with 5 cc of beta-tricalcium phosphate foam (Vitoss™, Orthovita) and 3.5 ml of patient's blood, and inserted between the transverse processes of the lumbar spine. All subjects will be hospitalized and followed up as per standard medical care rules used in the investigational site hospital for this type of intervention.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Human AMSC (passage 3) 3P in 1.5 mL
    Arm Type
    Experimental
    Arm Description
    Patient receiving the investigational medicinal product - suspension of human autologous MSC 3P in 1.5 mL
    Intervention Type
    Drug
    Intervention Name(s)
    Suspension of human autologous MSC 3P in 1.5 ml
    Other Intervention Name(s)
    hAMSC
    Intervention Description
    During the posterolateral spine fusion operation, 1.5 ml of cell suspension was mixed with 5cc of beta-tricalcium phosphate foam and 3.5 ml of patient's blood, and inserted between the right transverse processes of the lumbar spine.
    Primary Outcome Measure Information:
    Title
    Safety: To demonstrate absence of complications at the site of spinal fusion
    Description
    Complications at the site of spinal fusion and other treatment-related adverse events will be recorded in ten patients at Visits I through VII. All adverse events (AEs) will be classified by seriousness, severity and relationship to hAMSC application. All AEs will be collected as symptoms spontaneously reported by the patient, clinically relevant changes and abnormalities observed by the Investigator (clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations) Intensity The following 3-point rating scale will be used for rating of the intensity of each AE: Mild: Awareness of signs or symptoms, but no disruption of usual activity Moderate: Event sufficient to affect usual activities (disturbing) Severe: Inability to work or perform usual activities (unacceptable)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Efficacy: To assess the quality of life determined by Oswestry Questionnaire.
    Description
    The quality of life determined by Oswestry Questionnaire will be recorded in ten patients at Visits II, and IV through VII. The test has 10 sections and maximum score is 50 points; change from the baseline valie will be recorded. The points are then transferred into percentage and interpreted in a standard way when 0-20% means minimal disability while 81-100% means bed-bound condition. Minimum detectable change (90 % confidence) is 10 % (5 points).
    Time Frame
    1 year
    Title
    Efficacy: To assess the quality of spinal fusion by X-ray imaging
    Description
    The quality of spinal fusion will be measured by X-ray imaging at Visits V and VII. Dynamic X-ray of the lumbar spine will be performed at 3 and 12 months following the surgery and hAMSC application to measure the angle of the spine movement in the fusion area. The angle will be recorded in degrees. The movements above 10 degrees will beregarded as "unstable". The bone fusion morphology will be evaluated based on the following scale: Cyst or pseudo-cyst formation Fusion not visible Pseudo-joint (or false joint) development Low degree of bone fusion High degree of bone fusion
    Time Frame
    1 year
    Title
    Efficacy: To assess the quality of spinal fusion measured by computed tomography (CT).
    Description
    The quality of spinal fusion will be measured by CT in ten patients at Visits V and VII. The density will of the fusion will be expressed as % on a linear scale between two standardized measuring points: soft tissue= 0%, vertebral arch= 100%.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: established diagnosis of spinal degenerative disease indicated for lumbar spine surgery, patients indicated for fusion therapy, patients between 18-55 years, both sexes, patients able to provide written informed consent. Exclusion Criteria: previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion, osteoporosis, diabetes mellitus, pregnancy or breastfeeding, women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners, fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube), coagulopathy, malnutrition, primary biliary cirrhosis, skin infection at the site of bone marrow aspiration or at the site of spinal fusion, gastrostomy, any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, recurrent thromboembolic disease .....), alcohol or drug abuse, cancer (compulsory clinical oncological screening), ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data will be published

    Learn more about this trial

    Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease

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