Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PLX-PAD · 4 trials · 5 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 | IM injection Single treatment; multiple injections |
| 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 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 being developed for peripheral artery disease, including intermittent claudication and critical limb ischemia, as well as for muscle injury following hip fracture surgery. It is administered by intramuscular injection and is currently in clinical trials, not yet approved by the FDA.
PLX-PAD is being developed by Pluri Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PLUR. The company is conducting clinical trials to evaluate the safety and efficacy of this cell therapy for cardiovascular and orthopedic indications.
PLX-PAD is in Phase 3 clinical development for the treatment of muscle injury following hip fracture arthroplasty. Earlier Phase 1 and Phase 2 trials have been completed for critical limb ischemia and intermittent claudication. The drug remains investigational and has not received regulatory approval.
PLX-PAD has completed four clinical trials. NCT00919958 and NCT00951210 were Phase 1 safety studies in critical limb ischemia. NCT01679990 was a Phase 2 trial in intermittent claudication. NCT03451916 is a Phase 3 study in hip fracture patients. All trials are completed.
PLX-PAD is a cell therapy derived from placental cells that are expanded and administered via intramuscular injection. The cells are intended to promote tissue repair and regeneration in damaged muscle and vascular tissue, potentially improving blood flow and functional recovery in affected patients.
PLX-PAD stands for PLacental eXpanded cells, and the drug is often referred to by this name in clinical literature. It is an allogeneic cell therapy product developed by Pluri Inc. for treating peripheral artery disease and muscle injury.