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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoFuse | Biological | Single Dose NeoFuse Surgical Implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Brown | Mesoblast, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia | ||
| Royal Melbourne Hospital |
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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).
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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).
| MasterGraft Granules | Device | Single Dose MaterGraft Granules Surgical Implantation |
|
|
| Melbourne |
| Victoria |
| 3050 |
| Australia |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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