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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01106417




Registration number
NCT01106417
Ethics application status
Date submitted
16/04/2010
Date registered
19/04/2010
Date last updated
29/06/2020

Titles & IDs
Public title
Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
Scientific 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
Secondary ID [1] 0 0
MSB-CF001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Degenerative Disc Disease 0 0
Degenerative Spondylolisthesis 0 0
Spinal Stenosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NeoFuse
Treatment: Devices - MasterGraft Granules

Experimental: 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.

Active comparator: 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 (ß-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


Treatment: Other: NeoFuse
Single Dose NeoFuse Surgical Implantation

Treatment: Devices: MasterGraft Granules
Single Dose MaterGraft Granules Surgical Implantation
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of NeoFuse
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Fusion success with NeoFuse
Timepoint [1] 0 0
1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mesoblast, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.
Trial website
https://clinicaltrials.gov/study/NCT01106417
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roger Brown
Address 0 0
Mesoblast, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01106417