PSTI and the Berlin-Brandenburg Center for Regenerative Therapies (BCRT), in cooperation with the Charite – University of Medicine in Berlin, announced (3/1/11) the results of a pre-clinical study demonstrating that the local administration of PLX cells following muscle injury resulted in significant improvement in the recovery of muscle function when compared with the control group.
- This study suggests that PSTI’s PLX cells have the potential to treat both accidental and intentionally induced muscle injuries;
- These trials will be conducted in addition to the anticipated Phase II/III trial using PLX-PAD for the treatment of Critical Limb Ischemia;
- The data from the study indicates that PLX cells can be used in several categories of muscle injury, including accidental injuries, such as those incurred during athletic activity, as well as intentional injuries, such as after the incision of a skeletal muscle during surgery;
- During the study, either immediately or 7 days after delivering injury to the soleus muscle, PLX cells or saline were injected into the traumatized muscles. 4 weeks after administration, the regenerative capacity of the soleus muscle was measured bilaterally by stimulating the sciatic nerve.
The Bottom Line: The study demonstrates the great potential that PSTI’s PLX cells hold for treating injuries. PLX cell administration resulted in a significant improvement in the recovery of function of the involved muscles. The successful completion of these pre-clinical studies opens an additional product candidate in the PLX platform pipeline. PLX cells might be able to be used as an adjuvant therapy for the recovery of muscle function following hip replacement surgery. A major problem for surgeons, especially in endoprosthetics, is muscular deficiencies, in particular muscular atrophy. This approach of using PLX cells as adjuvant therapy to an orthopedic surgery is a unique opportunity to improve the healing outcomes. Subject to regulatory approval, PSTI plans on moving ahead with clinical trials for muscle injury indications. These markets might represent a potential annual market of approximately $10B.