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150M PLX-PAD · 1 trial · 2 indications
Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.
| Arm | Type | Description |
|---|---|---|
| 150M PLX-PAD | EXPERIMENTAL | Single course, multiple IM injections |
| 300M PLX-PAD | EXPERIMENTAL | Single course, multiple IM injections |
| Placebo | PLACEBO_COMPARATOR | Single course, multiple IM injections |
| Name | Type | Description |
|---|---|---|
| 150M PLX-PAD | BIOLOGICAL | Single course, multiple IM injections |
| 300M PLX-PAD | BIOLOGICAL | Single course, multiple IM injections |
| Placebo | BIOLOGICAL | Single course, multiple IM injections |
Inclusion Criteria: 1. Male or female subjects between 50 to 75 years of age 2. Scheduled THA 3. ASA Score ≤ 3 4. Signed written informed consent Exclusion Criteria: 1. Muscle diseases 2. Severe neurological diseases 3. Opioid long term medication 4. Pain chronification \> stadium II of Gerbersha...
150M PLX-PAD is an investigational cell-based therapy developed by Pluri Inc. (ticker PLUR) for regeneration of injured gluteal musculature following total hip arthroplasty. It is administered as intramuscular injections and has been studied in a single completed Phase 1 clinical trial in Germany.
150M PLX-PAD is being developed for the regeneration of injured gluteal musculature after total hip arthroplasty. The therapy is intended to support muscle repair in patients undergoing this surgical procedure. It is investigational and has not been approved for commercial use.
150M PLX-PAD is developed by Pluri Inc., which trades under the ticker PLUR. The company is responsible for the clinical development of this cell therapy candidate.
150M PLX-PAD is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently approved by the FDA or any regulatory agency. The trial has been completed, and no active trials are ongoing.
150M PLX-PAD has been evaluated in one completed Phase 1 trial, NCT01525667, titled Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty. The trial enrolled 20 participants in Germany and was randomized, double-blind, and placebo-controlled.