Regenmedtx (United States)

Bioreactors are used to dynamically condition engineered tissues to achieve the required degree of maturation before in vivo implantation. Integrating sensors and imaging capabilities into bioreactors can help us understand how the culture environment influences tissue maturation and growth. Additionally, this enables the monitoring of tissue constructs and provides critical information for quality control. This study aimed to develop a standardized, self-contained, uniaxial bioreactor module for the clinical manufacturing of tissue constructs; this system would benefit from unidirectional mechanical or electrical stimulation, or both. We achieved this goal by integrating stimulation and sensing components that provide an optimal culture environment and monitoring capabilities to improve tissue manufacturing. The uniaxial bioreactor module included integrated, user-friendly mechanical and electrical stimulations with force measurement to enhance the preconditioning of the engineered tissues. Also, a sensor loop and media exchange system were integrated to monitor the culture environment and cellular metabolites over time, and the camera system above the tissue construct enabled the macroscopic visualization of tissue maturation. Furthermore, the onboard media exchange system was programmed into the module to maintain aseptic culture conditions in the long term. Subsequently, using native skeletal muscle tissue and tissue-engineered skeletal muscle constructs, the performance of the uniaxial bioreactor module was validated for its application in preconditioning and enhancing tissue maturation.

Regenerative medicine (RM) is a fascinating area of research and innovation. The huge potential of the field has been fairly underexploited so far. Both TERMIS-AM and TERMIS-EU Industry Committees are committed to mentoring and training young entrepreneurs for more successful commercial translation of upstream research. With this objective in mind, the two entities jointly organized an industry symposium during the past TERMIS World Congress (Boston, September 8-11, 2015) and invited senior managers of the RM industry for lectures and panel discussions. One of the two sessions of the symposium-How to overcome obstacles encountered when bringing products to the commercial phase?-aimed to share the inside, real experiences of leaders from TEI Biosciences (an Integra Company), Vericel (formerly Aastrom; acquirer of Genzyme Regenerative Medicine assets), RegenMedTX (formerly Tengion), Mindset Rx, ViThera Pharmaceuticals, and L'Oreal Research & Innovation. The symposium provided practical recommendations for RM product development, for remaining critical and objective when reviewing progress, for keeping solutions simple, and for remaining relevant and persistent.

ABSTRACTIntroduction: Application of regenerative medicine strategies for repair of organs/tissue impacted by chronic disease is an active subject for product development. Such methodologies emphasize the role of stem cells as the active biological ingredient. However, recent developments in elucidating mechanisms of action of these therapies have focused on the role of paracrine, ‘action-at-a-distance’ modus operandi in mediating the ability to catalyze regenerative outcomes without significant site-specific engraftment. A salient component of this secreted regenerative milieu are exosomes: 40–100 nm intraluminal vesicles that mediate transfer of proteins and nucleic acids across cellular boundaries.Areas covered: Here, we synthesize recent studies from PubMed and Google Scholar highlighting how cell-based therapeutics and cosmeceutics are transitioning towards the secretome generally and exosomes specifically as a principal modulator of regenerative outcomes.Expert opinion: Exosomes contribute to organ development and mediate regenerative outcomes in injury and disease that recapitulate observed bioactivity of stem cell populations. Encapsulation of the active biological ingredients of regeneration within non-living exosome carriers may offer process, manufacturing and regulatory advantages over stem cell-based therapies.