None listed
Conditions
Interventions
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 cervica
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.
Sponsors
Mesoblast Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or females between 18 and 70 years of age, inclusive
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.
Outcome results
None listed