A Ready-to-Use Purified Exosome Product for Volumetric Muscle Loss and Functional Recovery.

Large skeletal muscle defects owing to trauma or following tumor extirpation can result in substantial functional impairment. Purified exosomes are now available clinically and have been used for wound healing. The objective of this study was to evaluate the regenerative capacity of commercially available exosomes on an animal model of volumetric muscle loss (VML) and its potential translation to human muscle injury.

The Safety of Adiponectin Receptor Agonist AdipoRon in a Rabbit Model of Arthrofibrosis.

AdipoRon is an adiponectin receptor 1, 2 (ADIPOR1 and ADIPOR2) agonist with numerous reported physiological benefits in murine models of human disease, including a proposed reduction in fibrosis. However, AdipoRon has never been investigated in rabbits, which provide a robust model for orthopedic conditions. We examined the safety of intravenous (IV) AdipoRon in New Zealand White (NZW) female rabbits surgically stressed by a procedure that mimics human arthrofibrosis.

Establishing a Current Good Manufacturing Practice Facility for Biomaterials and Biomolecules in an Academic Medical Center.

This article describes the feasibility and path to establishing a current good manufacturing practice biomaterial facility in an academic medical center. It presents a solution to overcome the "Valley of Death" in bench to bedside translation of biomaterials-based medical devices. It sets a good and feasible example to those who are interested in joining the path toward clinical practice/commercialization, and helps to spur other institutions and investigators to think about how they could incorporate in-house processes and facilities to help speed up the translation of their work into first-in-human trials.