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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 a cervical Allograft Spacer 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 |
|---|---|---|---|
| Allograft | Active Comparator | Cervical Spinal Fusion with Allograft |
|
| NeoFuse | Experimental | Cervical Spinal Fusion with NeoFuse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoFuse | Biological | Single Dose NeoFuse Surgical Implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|---|---|---|
| To evaluate the fusion success with NeoFuse compared to allograft spacer 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 years |
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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 |
|---|---|---|---|---|---|---|
| UC Davis Spine Center | Sacramento | California | 95816 | United States | ||
| The Spine Institute |
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| Allograft | Procedure | Single Dose Allograft Surgical Implantation |
|
|
| Santa Monica |
| California |
| 90403 |
| United States |
| Denver Spine | Denver | Colorado | 80111 | United States |
| Rocky Mountain Associates in Orthopedic Medicine, P.C. | Loveland | Colorado | 80538 | United States |
| Tallahassee Neurological Clinic, P.A. | Tallahassee | Florida | 32308 | United States |
| Fort Wayne Orthopaedics | Fort Wayne | Indiana | 46804 | United States |
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28204 | United States |
| Central Texas Spine Institute | Austin | Texas | 78705 | United States |
| 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 |
| D014184 | Transplantation, Homologous |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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