Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion

June 1, 2020 updated by: Mesoblast, Ltd.

A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With Mastergraft Granules in Subjects Undergoing Posterolateral Lumbar Fusion With Instrumentation

The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing posterolateral lumbar fusion.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, 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, 9, and 12 months after surgery.

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

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Plano, Texas, United States, 75093
        • Texas Back Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or females at least 18 years of age, but not older than 70.
  2. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
  3. Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US or applicable regulations outside the US].
  4. 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
  5. Have clinical symptoms of neurogenic claudication.
  6. Have failed 6 months of non-operative low back pain management.
  7. Are candidates for lumbar interbody fusion with autograft in combination with posterolateral fusion and require surgery at a 1 or 2 adjacent vertebral levels between L1 and S1
  8. Have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery -

Exclusion Criteria:

  1. Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
  2. Have a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening.
  3. Have osteoporosis as defined by a DEXA T score of ≤ -3.5 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
  4. Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
  5. Have a positive screen for human immunodeficiency virus (HIV) antibodies
  6. Have had treatment with any investigational therapy or device within 6 months of study surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 3-year follow-up period.
  7. Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
  8. Have a body mass index (BMI) > 35.
  9. Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.

  10. Are transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Autograft
Procedure: PLF with autograft
6 subjects
Other Names:
  • spinal fusion
Experimental: 2
Low Dose MPCs
Biological: PLF with NeoFuse
6 subjects low dose
Other Names:
  • spinal fusion
  • stem cell
Biological: PLF with NeoFuse
6 subjects medium dose
Other Names:
  • spinal fusion
  • stem cell
Biological: PLF with NeoFuse
6 subjects high dose
Other Names:
  • spinal fusion
  • stem cell
Experimental: 3
Medium Dose MPCs
Biological: PLF with NeoFuse
6 subjects low dose
Other Names:
  • spinal fusion
  • stem cell
Biological: PLF with NeoFuse
6 subjects medium dose
Other Names:
  • spinal fusion
  • stem cell
Biological: PLF with NeoFuse
6 subjects high dose
Other Names:
  • spinal fusion
  • stem cell
Experimental: 4
High Dose MPCs
Biological: PLF with NeoFuse
6 subjects low dose
Other Names:
  • spinal fusion
  • stem cell
Biological: PLF with NeoFuse
6 subjects medium dose
Other Names:
  • spinal fusion
  • stem cell
Biological: PLF with NeoFuse
6 subjects high dose
Other Names:
  • spinal fusion
  • stem cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 (PLF) with instrumentation
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the overall fusion success with NeoFuse plus carrier compared to autograft using CT scans and x-ray of the involved lumbar spine levels and access the change in outcomes (ODI, SF-36) and pain (VAS)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesoblast, Ltd.

Investigators

  • Principal Investigator: Donna Skerrett, MD, Mesoblast, Ltd., c/o Angioblast Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSB-SF002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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