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Trial registered on ANZCTR
Registration number
ACTRN12609001049268
Ethics application status
Approved
Date submitted
21/05/2009
Date registered
8/12/2009
Date last updated
20/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A Phase 1b/2a, Randomised, Single-Blinded, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse(TM) when combined with MasterGraft (TM) matrix in Patients Undergoing Multi-Level Anterior Cervical Discectomy and Fusion with Anterior Cervical Plate Fixation.
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Scientific title
A Phase 1b/2a, Randomized, Double-Blinded, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse (TradeMark) when Combined with MasterGraft Granules in Subjects Undergoing Multi-Level Anterior Cervical Discectomy.
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Secondary ID [1]
883
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Nil
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Universal Trial Number (UTN)
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Trial acronym
ACDF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anterior cervical discectomy with interbody cage and fusion
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Condition category
Condition code
Neurological
237171
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0
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Other neurological disorders
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Surgery
252471
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Surgically/direct sterile application of 10 Million Mesenchymal Precursor Cells and Mastergraft Matrix made of medical grade combination of purified collagen and biphasic calcium phosphate ceramic. The collagen is highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of MasterGraft(TM) Matrix is provided in a 15% hydroxyapatite and 85% b-tricalcium phosphate formulation. The cells and matrix will be prepared/combined and implanted at each involved cervical level for a total dose of 20 or 30 million cells or mastergraft granules only per involved cervical level. The duration of an anterior cervical discectomy and fusion procedure is 2-3 hours.
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Intervention code [1]
4607
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Treatment: Surgery
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Comparator / control treatment
MasterGraft Granules - granules are mixed with venous blood and placed into a cervical cage.
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Control group
Active
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Outcomes
Primary outcome [1]
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To determine the safety and feasibility of interbody fusion with and exploratory dose of NeoFuse (allogeneic mesenchymal precursor cells [MPCs]), combined with Mastergraft Matrix as a carrier and radiolucent cervical cage for multi-level anterior cervical discectomy and fusion (ACDF) with anterior cervical plate fixation through 12 months follow-up of adverse events.
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Assessment method [1]
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Timepoint [1]
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Each subject will be followed for 2 years after surgery and will have assessments at screening, during surgery, post operatively at 1 to 3 days and 30 days, and again at 3, 6, 12 and 24 months after surgery.
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Secondary outcome [1]
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To evaluate the overall fusion success with NeoFuse plus Mastergraft Matrix compared to control (Mastergraft Granules) using computed tomography (CT) scans of the involved cervical spine levels through 12 months.
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Assessment method [1]
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Timepoint [1]
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3, 6, 12 months post surgery
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Secondary outcome [2]
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To evaluate the overall fusion success with NeoFuse plus Mastergraft Matrix compared to control (Mastergraft Granules) using flexion/extension, anteroposterior (AP), and lateral radiographs through 12 months. Radiographic fusion success will be determined by measuring the degrees of angular motion and bridging bone between the involved vertebral endplates.
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Assessment method [2]
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Timepoint [2]
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1, 3, 6, 12 months post surgery
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Secondary outcome [3]
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To evaluate the change from baseline in the Neck Disability Index (NDI)
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Assessment method [3]
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Timepoint [3]
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1, 3, 6, 12 and 24 months post surgery
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Secondary outcome [4]
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To evaluate the change from baseline in the Medical Outcome Study Short Form (SF-36)
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Assessment method [4]
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Timepoint [4]
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1, 3, 6, 12 and 24 months post surgery
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Secondary outcome [5]
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To evaluate the change from baseline in pain level using the visual analog scale (VAS) for neck and arms
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Assessment method [5]
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Timepoint [5]
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1, 3, 6, 12 and 24 months post surgery
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Secondary outcome [6]
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To evaluate the change from baseline in subjects psychological well being using Zung Depression Scale
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Assessment method [6]
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Timepoint [6]
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1, 3, 6, 12 and 24 months post surgery
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Secondary outcome [7]
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To evaluate the change from baseline in participants Work Productivity Activity Index (WPAI)
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Assessment method [7]
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Timepoint [7]
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1, 3, 6, 12 and 24 months post surgery.
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Eligibility
Key inclusion criteria
1. Male or females between 18 and 70 years of age, inclusive
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded from participating in the study if they meet any of the following exclusion criteria:
1. Female participants who are pregnant or breast feeding or women planning to become pregnant during the first year (12 months) following surgery
2. Has at the time of surgery a systemic or local infection at the site of proposed surgery.
3. Has or is undergoing revision of a prior fusion surgery at any involved level.
4. Requires ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
5. Requires ACDF without the use of an anterior cervical plating system.
6. Has an acute fracture of the cervical spine at the time of enrollment in the study
7. Has a history of epidural steroid injections within 1 week prior to study treatment
8. Has received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone = 10 mg/day within 14 days prior to study procedure and/or is unwilling to refrain from systemic use of corticosteroids for the first 6 months following surgery
9. Has received systemic or local injections into the index and/or adjacent vertebral levels nonsteroidal anti-inflammatory drugs (NSAIDS) within 48 hours prior to study procedure and/or is unwilling to refrain from such treatments with NSAIDS for the first 6 months following surgery.
10. Has a known history of hypersensitivity or anaphylactic reaction to murine or bovine products, dimethyl sulfoxide (DMSO), or calcium-phosphate (CaPO4)-based synthetic bone graft substitutes.
11. 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.
12. Have 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
13. Has systemic immune disease requiring chronic steroid therapy.
14. Plan or require the use of bone growth stimulator devices (implantable or not) as an adjunct to surgery or during the trial 24-months duration.
15. Plan or require the use of osteobiologic bone growth stimulator devices, e.g., bone morphogenetic proteins (BMPs) at fusion surgery or during this trial’s 24-months duration.
16. Has a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process (e.g. history of Paget’s disease, osteomalacia, or other osteodystrophy).
17. Has a positive screen for human immunodeficiency virus (HIV) antibodies.
18. 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.
19. Has been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
20. Has a medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation (e.g., histories of transient ischemic attack (TIA), stroke, uncontrolled diabetes, or liver disease).
21. Has 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
22. 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.
23. Currently has Syphilis
24. Currently incarcerated (prisoners).
25. Unable to complete follow-up according to the protocol.
26. Have a mental illness that could prevent completion of the study or protocol questionnaires.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation envelopes prepared by a biostatistitian with assigned/allocaed randomisation numbers. Once the patient is found to be eligible and surgery date confirmed, an unblided study delegate will select an envelope and assign the randomisation number and treatment to the patient.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible subjects will be randomized to receive one of two treatments at each fusion level: NeoFuse TradeMark (TM) 10 million allogeneic MPCs per involved interbody space combined with MasterGraft (TM) Granules or MasterGraft(TM) Granules alone (control). The treatment will be administered as a direct sterile application to the involved level(s), for a total dose per study subject of either 20 or 30 million MPCs if study subject randomised to 10 million MPCs. Randomisation numbers will be assigned as per the randomisation envelopes preprapared by the biostatitician. The biostatistitian will use a simple randomisation table to create the code placed in the envelopes. This table will be generated using computer software (i.e., computerised sequence generation). The envelopes will be supplied to the cell storage facility and the unblinded persnnel will select the next envelope in sequence that will indicate the randomisation number and dose for that patient.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Eligible subjects will be randomized to receive one of two treatments at each fusion level: NeoFuse TradeMark (TM) 10 million allogeneic MPCs per involved interbody space combined with MasterGraft (TM) Granules or MasterGraft(TM) Granules alone (control). The treatment will be administered as a direct sterile application to the involved level(s), for a total dose per study subject of either 20 or 30 million MPCs if study subject randomised to 10 million MPCs.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
12/07/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Mesoblast Ltd
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Address [1]
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Level 39
55 Collins Street
Melbourne
Victoria 3000
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Mesoblast Ltd
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Address
Level 39
55 Collins Street
Melbourne
Victoria 3000
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Epworth Healthcare
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Ethics committee address [1]
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Level 5
Leigh Place
Epworth Hospital
Richmond Victoria 3121
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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18/12/2008
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Approval date [1]
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04/02/2009
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Ethics approval number [1]
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43509
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Ethics committee name [2]
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Melbourne Health Ethics Committee
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Ethics committee address [2]
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Royal Melbourne Hospital
Parkville Victoria 3050
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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18/11/2009
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Ethics approval number [2]
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2009.226
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Ethics committee name [3]
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Southern Health Research Directorate
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Ethics committee address [3]
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Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
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Approval date [3]
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22/06/2010
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Ethics approval number [3]
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10085B
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toula Papadimitrakis
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Address
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Level 39
55 Collins Street
Melbourne 3000
Victoria
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Country
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Australia
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Phone
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+61 3 9639 6036
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Fax
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+ 61 3 9639 6030
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Email
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[email protected]
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Contact person for scientific queries
Name
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Toula Papadimitrakis
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Address
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Level 39
55 Collins Street
Melbourne 3000
Victoria
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Country
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Australia
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Phone
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+61 3 9639 6036
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Fax
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+61 3 9639 6030
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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