Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PLX-PAD IM injection, PLX-PAD Low dose
PLX-PAD · 5 trials · 6 indications
| 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). |
| PLX-PAD Low dose | EXPERIMENTAL | PLX-PAD double low doses |
| PLX-PAD high doses | ACTIVE_COMPARATOR | PLX-PAD double high dose |
| PLX-PAD high dose +Placebo | EXPERIMENTAL | High dose+Placebo |
| PLX-PAD high dose | EXPERIMENTAL | IM injection Double treatment; multiple injections |
| PLX-PAD intermediate dose | EXPERIMENTAL | - |
| 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). |
| PLX-PAD Low dose | BIOLOGICAL | - |
| PLX-PAD high doses | BIOLOGICAL | - |
| Double Placebo | BIOLOGICAL | - |
| high dose +Placebo | BIOLOGICAL | - |
| PLX-PAD IM injection | BIOLOGICAL | Single treatment; multiple injections |
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...
PLX-PAD is an investigational cell therapy developed by Pluri Inc. (ticker PLUR) for cardiovascular and musculoskeletal conditions. It is being studied in critical limb ischemia, hip fracture, intermittent claudication, and peripheral artery disease. PLX-PAD is administered as an intramuscular injection and is currently in Phase 3 clinical development.
PLX-PAD is being studied for critical limb ischemia (CLI), hip fracture, intermittent claudication, and peripheral artery disease. The Phase 3 program includes a trial in CLI patients with minor tissue loss who are unsuitable for revascularization and a trial in muscle injury following arthroplasty for hip fracture.
PLX-PAD is developed by Pluri Inc., which trades under the ticker PLUR. Pluri is the sponsor of the clinical development program for PLX-PAD across its cardiovascular and musculoskeletal indications.
PLX-PAD is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 program includes trials in critical limb ischemia and hip fracture, with earlier Phase 1 and Phase 2 studies also completed.
PLX-PAD has been studied in four completed trials: NCT03451916 in hip fracture (Phase 3, 240 patients), NCT03006770 in critical limb ischemia (Phase 3, 213 patients), NCT01679990 in intermittent claudication and peripheral artery disease (Phase 2, 180 patients), and NCT00951210 in critical limb ischemia (Phase 1, 12 patients).
Yes. PLX-PAD is also referred to as PLX-PAD IM injection and PLX-PAD Low dose. These names refer to the same investigational cell therapy developed by Pluri Inc. (PLUR), which is administered via intramuscular injection and studied across critical limb ischemia, hip fracture, intermittent claudication, and peripheral artery disease.