Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy

NCT01097486

Cervical Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis

COMPLETED PHASE2

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

NCT00810212

Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis

WITHDRAWN PHASE1/PHASE2

Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion

NCT00996073

Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis

COMPLETED PHASE2

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

NCT00549913

Degenerative Disc Disease Spondylolisthesis Spinal Stenosis

COMPLETED PHASE1/PHASE2

A Prospective Study of NuCel® in Cervical Spine Fusion

NCT02381067

Spondylosis Spinal Stenosis Spondylolisthesis +2 more

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, multicenter, randomized, single-blinded, controlled study evaluating safety and preliminary efficacy of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Matrix in a commercially available PEEK cervical Spacer compared to an active control in subjects undergoing 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.

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, 12, and 24 months after surgery.

Subjects will be evaluated at the same time points for safety.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects received treatment in one of two parallel arms.

Treatment Arm 1; NeoFuse (a biologic, consisting of STRO-3 immunological selected allogeneic Mesenchymal Precursor Cells, derived from adult bone marrow mononucleated cells) with Mastergraft Matrix (a medical device that is compression resistant and embedded with Mastergraft Granules). Subjects received 10 million Neufuse cells per treated cervical interbody level involved in the fusion. Either 2 or 3 levels were involved for a total of either 20 million or 30 million Neofuse cells.

Treatment Arm 2; Mastergraft Granules (medical device made of medical grade combination of hydroxyapatite and beta-tricalcium phosphate).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

This is a single-blinded study. The study participants will be blinded to the study randomisation assignment and study treatment they receive. In addition, every effort will be made by the Sponsor and Investigator to maintain the study blind. Treatment assignment will occur in sequential chronological order according to a central master list of random assignments prepared by the study statistician (master randomization list).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NeoFuse

Anterior Cervical Discectomy and Fusion with NeoFuse.

NeoFuseTM is constituted of STRO-3 immunological selected allogeneic MPCs, which are derived from adult bone marrow mononucleated cells that are culture-expanded and subsequently cryopreserved.

The allogeneic MPCs are formulated in concentrations of nucleated cells in a 5 mL volume and are cryopreserved in 7.5% dimethyl sulfoxide (DMSO)/50% Alpha Modified Eagle's Medium (MEM) and 42.5% ProFreeze®. The final formulation consists of 0.15mL (approximately 10 million MPCs) of thawed NeoFuse™ thawed NeoFuseTM combined with the amount of MasterGraftTM Matrix to fill the PEEK cage per ACDF level.

Group Type EXPERIMENTAL

NeoFuse

Intervention Type BIOLOGICAL

Single Dose NeoFuse Surgical Implantation

MasterGraft Granules

Anterior Cervical Discectomy and Fusion with MasterGraft Granules

MASTERGRAFT® GRANULES are a medical-grade, polyporous resorbable ceramic hybrid composed of 15% hydroxyapatite (HA) and 85% beta-tricalcium phosphate (β-TCP). The combination of these natural bone materials provides surgeons with an osteoconductive, porous implant that improves osteointegration by allowing cells to colonize throughout the implant and optimize the bone healing process

Group Type ACTIVE_COMPARATOR

MasterGraft Granules

Intervention Type DEVICE

Single Dose MaterGraft Granules Surgical Implantation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NeoFuse

Single Dose NeoFuse Surgical Implantation

Intervention Type BIOLOGICAL

MasterGraft Granules

Single Dose MaterGraft Granules Surgical Implantation

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Anterior Cervical Discectomy and Fusion with NeoFuse Cervical Spinal Fusion Adult Stem Cells Anterior Cervical Discectomy and Fusion with Granules Cervical Spinal Fusion Active Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or females between 18 and 70 years of age, inclusive.
2. Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
3. Has the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI).
4. Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1.
5. Has symptomatic radiculopathy and/or myelopathy correlating to radiographic findings of duration of 6 weeks or greater that had failed to respond to non-operative management
6. Is a candidate for anterior cervical discectomy and fusion in two or three adjacent cervical interbody levels between C3-C4 to C7-T1
7. Has 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. Has 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. Has at the time of surgery a systemic or local infection at the site of proposed surgery.
4. Has or is undergoing revision of a prior fusion surgery at any involved level.
5. Requires ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
6. Requires ACDF without the use of an anterior cervical plating system.
7. Has osteoporosis as defined by a DEXA T score of ≤ -3.0 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
8. Has a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
9. Has a positive screen for human immunodeficiency virus (HIV) antibodies.
10. Has 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 2-year follow-up period.
11. Has been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
12. Has 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
13. Is transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No