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Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)

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ClinicalTrials.gov Identifier: NCT00549913
Recruitment Status : Completed
First Posted : October 26, 2007
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.

Tracking Information
First Submitted Date  ICMJE October 24, 2007
First Posted Date  ICMJE October 26, 2007
Last Update Posted Date November 7, 2014
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
To determine the safety of NeoFuse (allogeneic mesenchymal precursor cells [MPCs]) when combined with MasterGraft Resorbable Ceramic Granules as a carrier for posterolateral lumbar fusion with instrumentation. [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00549913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
  • To evaluate the overall fusion success of the use of NeoFuse plus carrier compared to autograft in the same patient [ Time Frame: 3 years ]
  • To assess CT scan as a pilot measure of fusion for use in the pivotal study [ Time Frame: 3 years ]
  • To provide preliminary data to support dose selection [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
Official Title  ICMJE A Dose-escalation Study to Assess the Feasibility and Safety of 3 Different Doses of NeoFuse When Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion With Instrumentation.
Brief Summary This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules (Medtronic Sofamor Danek USA, Inc.) compared to autograft in patients requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage (to be used with autologous bone graft material) and 1 or 2 level posterolateral lumbar fusion surgery with instrumentation. The instrumentation used for this study will be the Monarch® 5.50 mm Spine System (DePuy).
Detailed Description

This is a prospective, single center, randomized, open-label controlled Phase 1b/2a study designed to evaluate the safety and preliminary efficacy of MPCs combined with MasterGraft Granules when compared to use of autologous bone graft in the posterolateral fusion site in subjects requiring interbody fusion in combination with instrumented 1 or 2 level PLF procedure. All subjects in this study will undergo a 1 or 2-level (2 or 3 vertebrae) interbody fusion without the use of the investigational product.

In addition to the interbody fusion procedure, subjects will undergo an instrumented posterolateral fusion. NeoFuse plus MasterGraft Granules at one of three doses or autograft will be implanted in the posterolateral lumbar fusion site(s) only.

After the screening and surgical visits, each subject will be evaluated clinically and radiographically within 3 days and 30 days after surgery, and at 3, 6, and 12 months after surgery.

Subjects will be evaluated at 24 and 36 months after surgery for safety.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Disc Disease
  • Spondylolisthesis
  • Spinal Stenosis
Intervention  ICMJE
  • Genetic: NeoFuse
    immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Resorbable Ceramic Granules in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
    Other Names:
    • Spinal Fusion
    • Stem Cells
  • Procedure: posterolateral spinal fusion with instrumentation
    autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
    Other Names:
    • Spinal Fusion
    • Controls
Study Arms  ICMJE
  • Experimental: 1
    10 subjects to receive lowest dose of NeoFuse (MPCs)
    Intervention: Genetic: NeoFuse
  • Active Comparator: 2
    4 subjects standard posterolateral spinal fusion with instrumentation
    Intervention: Procedure: posterolateral spinal fusion with instrumentation
  • Experimental: 3
    10 subjects to receive middle dose of NeoFuse
    Intervention: Genetic: NeoFuse
  • Active Comparator: 4
    3 subjects standard posterolateral spinal fusion with instrumentation
    Intervention: Procedure: posterolateral spinal fusion with instrumentation
  • Experimental: 5
    10 subjects to receive highest dose of NeoFuse
    Intervention: Genetic: NeoFuse
  • Active Comparator: 6
    3 subjects with standard posterolateral spinal fusion with instrumentation
    Intervention: Procedure: posterolateral spinal fusion with instrumentation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2013)
6
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2007)
40
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women ≥ 18 years of age.
  2. Have a documented symptomatic diagnosis of DDD at L1-S1 with or without stenosis and with or without up to and including Grade II degenerative spondylolisthesis.
  3. May also have coexistent spinal or foraminal stenosis as confirmed by MRI or CT evaluation.
  4. Must have clinical symptoms of neurogenic claudication.
  5. Must have failed 6 months of nonoperative management.
  6. Must be a candidate for lumbar interbody fusion in combination with posterolateral lumbar fusion with the use of autograft from the iliac crest requiring a 1 or 2-level fusion of adjacent vertebral levels between L1 and S1.
  7. Must have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.

Exclusion Criteria:

  1. Is pregnant or breastfeeding.
  2. Has Grade III or greater spondylolisthesis.
  3. Has or is undergoing revision of a prior fusion at the involved levels.
  4. Has a history of hypersensitivity or anaphylactic reaction to murine or bovine products, dimethyl sulfoxide (DMSO), or titanium.
  5. Has MRI or CT that shows greater than 50% anterior translocation of cranial vertebral body or greater than 20 degree angular motion of the listhesis segment.
  6. Has a history of active malignancy in the last 5 years, other than basal cell carcinoma.
  7. Has osteoporosis as defined by a dual energy x-ray absorptiometry (DXA T) score of ≤ -3.5 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.

    Note: subjects will be screened using the Simple Calculated Osteoporosis Risk Evaluation (SCORE) osteoporosis questionnaire.

  8. Has a history of Paget's disease of the spine, osteomalacia, or any other metabolic bone disease.
  9. Has a history of prior radiotherapy to the involved area.
  10. Has received systemic corticosteroids at a dose equivalent to prednisone > 10 mg/day within 14 days prior to study procedure.
  11. Has received systemic nonsteroidal anti-inflammatory drugs (NSAIDS) within 48 hours prior to study procedure, and unwilling to refrain from NSAIDS for the first 6 months following the procedure.
  12. Has a positive screen for human immunodeficiency virus (HIV) antibodies.
  13. Has had treatment with any investigational therapy administered within 6 months before implantation surgery. .
  14. Is the prior recipient of allogeneic stem cell/progenitor cell therapy.
  15. Has a body mass index (BMI) > 3.5
  16. Has 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00549913
Other Study ID Numbers  ICMJE MSF0106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mesoblast, Ltd.
Study Sponsor  ICMJE Mesoblast, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Donna Skerrett, MD Mesoblast, Ltd.
PRS Account Mesoblast, Ltd.
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP