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Also known as Cervical Spinal Fusion, Stem Cells, Adult Stem Cells, Spinal Fusion
NeoFuse · 3 trials · 5 indications
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).
| Arm | Type | Description |
|---|---|---|
| Allograft | ACTIVE_COMPARATOR | Cervical Spinal Fusion with Allograft |
| NeoFuse | EXPERIMENTAL | Cervical Spinal Fusion with 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 |
| 1 | EXPERIMENTAL | 10 subjects to receive lowest dose of NeoFuse (MPCs) |
| 2 | ACTIVE_COMPARATOR | 4 subjects standard posterolateral spinal fusion with instrumentation |
| 3 | EXPERIMENTAL | 10 subjects to receive middle dose of NeoFuse |
| 4 | ACTIVE_COMPARATOR | 3 subjects standard posterolateral spinal fusion with instrumentation |
| 5 | EXPERIMENTAL | 10 subjects to receive highest dose of NeoFuse |
| 6 | ACTIVE_COMPARATOR | 3 subjects with standard posterolateral spinal fusion with instrumentation |
| Name | Type | Description |
|---|---|---|
| NeoFuse | BIOLOGICAL | Single Dose NeoFuse Surgical Implantation |
| Allograft | PROCEDURE | Single Dose Allograft Surgical Implantation |
| MasterGraft Granules | DEVICE | Single Dose MaterGraft Granules Surgical Implantation |
| posterolateral spinal fusion with instrumentation | PROCEDURE | autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage |
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 us...
NeoFuse is an investigational cell therapy being developed for degenerative disc disease and cervical degenerative disc disease. It is studied in patients undergoing spinal fusion procedures, including posterolateral lumbar fusion and multi-level anterior cervical discectomy and fusion. The drug is in Phase 2 clinical development.
NeoFuse is being developed by Mesoblast Limited, a biopharmaceutical company listed on the stock exchange under the ticker MESO. Mesoblast is conducting clinical trials of NeoFuse in the United States and Australia for spinal fusion indications.
NeoFuse is in Phase 2 clinical development. It has completed two Phase 1 trials and one Phase 2 trial. The drug is investigational and has not been approved by regulatory authorities. All three clinical trials for NeoFuse have been completed.
NeoFuse has completed three clinical trials. NCT00549913 was a Phase 1 study of three doses in posterolateral lumbar fusion. NCT01097486 was a Phase 2 safety and efficacy study in multi-level anterior cervical discectomy. NCT01106417 was a Phase 1 study in multi-level anterior cervical discectomy and fusion.
NeoFuse is the primary name for this investigational cell therapy developed by Mesoblast. No alternative names have been reported for NeoFuse in clinical trial registrations. The drug is being studied under the name NeoFuse in all its completed clinical trials.