Cervical Degenerative Disc DiseasePhase 1/2NCT01106417
Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
A Phase 1/2 study testing NeoFuse and MasterGraft Granules in people with Cervical Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Mesoblast, Ltd. at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- What is being tested?
- NeoFuse and MasterGraft Granules
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesAustralia
- Study dates
- Jun 2010to Mar 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or females between 18 and 70 years of age, inclusive.
- Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Has the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI).
- Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1.
- 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
- Is a candidate for anterior cervical discectomy and fusion in two or three adjacent cervical interbody levels between C3-C4 to C7-T1
- Has a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.
Who cannot join
- Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
- 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.
- Has at the time of surgery a systemic or local infection at the site of proposed surgery.
- Has or is undergoing revision of a prior fusion surgery at any involved level.
- Requires ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
- Requires ACDF without the use of an anterior cervical plating system.
Show all 13Show fewer
- 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.
- Has a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
- Has a positive screen for human immunodeficiency virus (HIV) antibodies.
- 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.
- Has been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
- Has 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Monash Medical Centre
Clayton, Victoria, 3168
Royal Melbourne Hospital
Melbourne, Victoria, 3050
About this study
Official title: Phase 2 Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion With Anterior Cervical Plate Fixation
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.
Read the detailed description
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.
- Being tested
- NeoFuse, MasterGraft Granules
- Keywords
- Cervical Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis, Stem cells, Adult Stem Cells, Anterior cervical discectomy and Fusion (ACDF), Anterior Cervical Plate Fixation
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoFuseBiological
Also called Anterior Cervical Discectomy and Fusion with NeoFuse, Cervical Spinal Fusion, Adult Stem Cells
Single Dose NeoFuse Surgical Implantation
MasterGraft GranulesDevice
Also called Anterior Cervical Discectomy and Fusion with Granules, Cervical Spinal Fusion, Active Control
Single Dose MaterGraft Granules Surgical Implantation
| Study group | Role | What they receive |
|---|---|---|
| NeoFuse | Experimental | 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. Receives: Biological: NeoFuse |
| MasterGraft Granules | Active comparator | 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 Receives: Device: MasterGraft Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of NeoFuse
To determine the safety of NeoFuse using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and and immunology).
Measured: 2 years
Secondary outcomes (1)
Fusion success with NeoFuse
To evaluate the fusion success with NeoFuse compared to an active control using CT scans and x-ray of the involved cervical spine levels and assess the change in outcomes (NDI, SF-36, Zung Depression Questionnaire, and WPAI.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Brown, Study director, Mesoblast, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106417
- Sponsor's protocol ID
- MSB-CF001
- Status last verified
- Jun 2020
- First submitted
- 16 Apr 2010
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion With Anterior Cervical Plate Fixation
- ClinicalTrials.gov ID
- NCT01106417
- Acronym / sponsor ID
- MSB-CF001
- Keywords
- Cervical Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis, Stem cells, Adult Stem Cells, Anterior cervical discectomy and Fusion (ACDF), Anterior Cervical Plate Fixation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| NeoFuse | Experimental | Biological: NeoFuseAnterior 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. |
| MasterGraft Granules | Active comparator | Device: MasterGraft GranulesAnterior 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or females between 18 and 70 years of age, inclusive.
- Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Has the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI).
- Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1.
- 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
Key exclusion criteria (13 listed)
- Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
- 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.
- Has at the time of surgery a systemic or local infection at the site of proposed surgery.
- Has or is undergoing revision of a prior fusion surgery at any involved level.
- Requires ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoFuseAlso: Anterior Cervical Discectomy and Fusion with NeoFuse, Cervical Spinal Fusion, Adult Stem CellsSingle Dose NeoFuse Surgical Implantation | Biological | NeoFuse |
| MasterGraft GranulesAlso: Anterior Cervical Discectomy and Fusion with Granules, Cervical Spinal Fusion, Active ControlSingle Dose MaterGraft Granules Surgical Implantation | Device | MasterGraft Granules |
Primary outcome
Safety of NeoFuse
Time frame: 2 years
To determine the safety of NeoFuse using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and and immunology).
1 secondary outcome
Fusion success with NeoFuse
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Sponsor WebsiteLink provided by the sponsor.
Related trials for Cervical Degenerative Disc Disease
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
PMCF Study Fortilink-SC
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
Enrolling by invitation
Physiotherapy and Osteopathic Treatment for Pain in the Cervical and Lumbar Spine and Temporomandibular Joints
Disc Degenerative Disease, Spine Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Brown study director
Mesoblast, Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NeoFuse and MasterGraft Granules in people with Cervical Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Mesoblast, Ltd. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of NeoFuse (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.