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

Primary Purpose

Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PLF with autograft

PLF with NeoFuse

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative disc disease, Spondylolisthesis, Spinal stenosis, Stem cell, Spinal Fusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or females at least 18 years of age, but not older than 70.
Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
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].
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
Have clinical symptoms of neurogenic claudication.
Have failed 6 months of non-operative low back pain management.
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
Have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery -

Exclusion Criteria:

Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
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.
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.
Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
Have a positive screen for human immunodeficiency virus (HIV) antibodies
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.
Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
Have a body mass index (BMI) > 35.
Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
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.
-

Sites / Locations

Texas Back Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Autograft

Low Dose MPCs

Medium Dose MPCs

High Dose MPCs

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT00810212

First Posted

December 17, 2008

Last Updated

June 1, 2020

Sponsor

Mesoblast, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00810212

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor preferred a better study design

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2011 (Anticipated)

Study Completion Date

November 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mesoblast, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis

Keywords

Degenerative disc disease, Spondylolisthesis, Spinal stenosis, Stem cell, Spinal Fusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Subjects will be randomized to one of four (4) parallel treatment arms; autograft standard of care control, or one of three (3) doses of mesenchymal precursor cells (MPCs) combined with MasterGraft Granules. Subjects randomized to receive investigational product will be treated with one of the following three doses of allogeneic MPCs in 4 milliliters (mLs) per posterolateral lumbar fusion (PLF) level (204 mLs per side): 25 million (M), 50M or 75M MPCs per PLF level (or a total dose of 50 million, 100 million or 150 million MPCs if subject undergoes fusion at two levels). Each of the four treatment groups will include six (6) evaluable subjects.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Autograft

Arm Title

Arm Type

Experimental

Arm Description

Low Dose MPCs

Arm Title

Arm Type

Experimental

Arm Description

Medium Dose MPCs

Arm Title

Arm Type

Experimental

Arm Description

High Dose MPCs

Intervention Type

Procedure

Intervention Name(s)

PLF with autograft

Other Intervention Name(s)

spinal fusion

Intervention Description

6 subjects

Intervention Type

Biological

Intervention Name(s)

PLF with NeoFuse

Other Intervention Name(s)

spinal fusion, stem cell

Intervention Description

6 subjects low dose

Intervention Type

Biological

Intervention Name(s)

PLF with NeoFuse

Other Intervention Name(s)

spinal fusion, stem cell

Intervention Description

6 subjects medium dose

Intervention Type

Biological

Intervention Name(s)

PLF with NeoFuse

Other Intervention Name(s)

spinal fusion, stem cell

Intervention Description

6 subjects high dose

Primary Outcome Measure Information:

Title

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or females at least 18 years of age, but not older than 70. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. 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]. 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 Have clinical symptoms of neurogenic claudication. Have failed 6 months of non-operative low back pain management. 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 Have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery - Exclusion Criteria: Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery. 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. 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. Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process. Have a positive screen for human immunodeficiency virus (HIV) antibodies 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. Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery. Have a body mass index (BMI) > 35. Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens. 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donna Skerrett, MD

Organizational Affiliation

Mesoblast, Ltd., c/o Angioblast Systems, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Back Institute

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

12. IPD Sharing Statement

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

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