Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00996073 | Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion | PHASE2 | COMPLETED | 24 | — | — | Sep 1, 2009 | Jul 1, 2014 | Jun 29, 2020 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| Autograft | ACTIVE_COMPARATOR | Lumbar Interbody Fusion with Autograft |
| Low Dose | EXPERIMENTAL | Lumbar Interbody Fusion with NeoFuse-Low Dose |
| High Dose | EXPERIMENTAL | Lumbar Interbody Fusion with NeoFuse-High Dose |
| Name | Type | Description |
|---|---|---|
| Lumbar Interbody Fusion with Autograft | BIOLOGICAL | Single Dose Autograft Surgical Implantation |
| Lumbar Interbody Fusion with NeoFuse | BIOLOGICAL | Single Dose NeoFuse Surgical Implantation |
Inclusion Criteria: 1. Male or females at least 18 years of age, but not older than 70. 2. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. 3. Have the ability to understand and provide written authorization fo...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Mesoblast Limited Sponsored ADR | MESO | 1 | PHASE3 | Rexlemestrocel-L + HA mixture, Saline |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
| Stryker Corporation | SYK | 2 | NA | Undisclosed |
| Globus Medical Inc Class A | GMED | 6 | — | Undisclosed |
| Orthofix Medical, Inc. | OFIX | 1 | — | Undisclosed |