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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03451916 | Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF) | PHASE3 | COMPLETED | 240 | — | — | Jul 26, 2018 | Sep 6, 2023 | Sep 28, 2023 | 17 | United States, Bulgaria +3 |
| Arm | Type | Description |
|---|---|---|
| PLX-PAD | EXPERIMENTAL | • Arm 1 - PLX-PAD (120 subjects): 150×10\^6 PLX-PAD cells (10×10\^6 cells/mL) in a mixture containing 10% DMSO (v/v), 5% HSA (w/v) and PlasmaLyte. |
| Placebo | PLACEBO_COMPARATOR | Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO \[v/v\], 5% HSA \[w/v\], and PlasmaLyte, without cells). |
| Name | Type | Description |
|---|---|---|
| PLX-PAD | DRUG | PLX-PAD (120 subjects): 150×10\^6 PLX-PAD cells (10×10\^6 cells/mL) in a mixture containing 10% DMSO (v/v), 5% HSA (w/v) and PlasmaLyte |
| Placebo | DRUG | Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO \[v/v\], 5% HSA \[w/v\], and PlasmaLyte, without cells). |
Inclusion Criteria: 1. Male or female subjects 2. Subjects up to 90 years of age, inclusive, at the time of Screening 3. Subjects suffering low energy trauma with intracapsular neck of femur fracture. 4. Planned to be treated with total hip arthroplasty (THA) or hemi-arthroplasty (HA) within 48 hou...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 23 | NA | Undisclosed |
| Stryker Corporation | SYK | 4 | — | Undisclosed |
| Johnson & Johnson | JNJ | 1 | NA | Undisclosed |
| Orthofix Medical, Inc. | OFIX | 1 | — | Undisclosed |
| Cooper Companies, Inc. | COO | 1 | — | Undisclosed |