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

NCT00810212 | Withdrawn Phase 1 DMC

• 1 other identifier: MSB-SF002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (1)

• 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)

  3 years

Study Arms (4)

1

ACTIVE COMPARATOR

Autograft

Procedure: PLF with autograft

2

EXPERIMENTAL

Low Dose MPCs

Biological: PLF with NeoFuse

3

EXPERIMENTAL

Medium Dose MPCs

Biological: PLF with NeoFuse

4

EXPERIMENTAL

High Dose MPCs

Biological: PLF with NeoFuse

Interventions

PLF with autograft PROCEDURE

6 subjects

Also known as: spinal fusion

1

PLF with NeoFuse BIOLOGICAL

6 subjects low dose

Also known as: spinal fusion, stem cell

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mesoblast, Ltd.: lead

Study Sites (1)

Texas Back Institute

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis

Interventions

Transplantation, Autologous; Spinal Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Arthrodesis; Orthopedic Procedures

Study Officials

• Donna Skerrett, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 2, 2020

Record last verified: 2020-06

Locations

US (1)