Tissue Engineering

Tissue engineering refers to the process of combining scaffolds, cells, and/or biologically active molecules for the production of functional tissues. The potential to assemble functional constructs that restore, maintain, or improve damaged tissues or organs offers exciting prospects for changing traditional approaches to clinical treatment. The wide range of organs that present as strong candidates for engineering reconstruction–bone, cartilage, liver, pancreas, skin, blood vessel, and more–enables the field to meet critical health care needs and potentially treat a variety of diseases.

While tissue engineering has a broad definition and applications, the fundamental research and comprehensive clinical trial evaluations that will be required provide a significant need for the establishment of harmonized standards. There is an acute need for identification and assessment of leading technologies that have successfully come to market, and to extract insights from their manufacturers’ experience. The SCB is equipped to conduct this assessment and implement subsequent projects that guide consensus standards development and reference guidelines, with the ultimate goal of informing the global tissue engineering market with our initiatives. Elena Kfoury and Dr. Jason Wertheim lead the Tissue Engineering sector, with a comprehensive expertise in clinical, research, and industry perspectives.


Tissue engineering chairs

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Elena Kfoury is General Manager for Axiogenesis (North America) while serving as President / CEO of the international Standards Coordinating Body, a consortium of non-government stakeholders that operates through public-private partnerships with government regulatory agencies and other government organizations involved in helping to establish consensus standards for regenerative medicine products. Previously, Elena was principal of Polymath Consulting, where she advised manufacturers on combination medical device technology and regenerative medicine market and strategic planning. She also managed business development and strategic alliances / partnerships for the Harvard Stem Cell Institute (HSCI) and has held commercial roles at several benchmark cardiac medical device and specialty pharmaceutical companies, including Boston Scientific, Genzyme BioSurgery, and Elan Pharmaceuticals.  Elena earned her SM from Harvard University in Health Policy and Management and her BA in Neuroscience from Amherst College.  She also holds a Green Belt in Six Sigma (CSSGB) and Lean Six Sigma in Healthcare. 

Dr. Jason Wertheim serves as an Assistant Professor, a transplant surgeon and a biomedical engineer at Northwestern University. His research focuses on discovering new methods to develop liver and kidney tissue in the laboratory to alleviate the problem of organ shortage. His research involves a multidisciplinary, tissue engineering and regenerative medicine approach to developing organ scaffolds using pluripotent stem/progenitor cells that support the growth of new tissues that will eventually become whole organs. Dr. Wertheim's lab has partnered with the McCormick School of Engineering at Northwestern University and other leading academic and industrial centers to advance the field of tissue engineering and address the problem of organ shortage. Dr. Wertheim earned his BS in Chemical Engineering from MIT, and his MD in General Medicine and Ph.D. in Bioengineering from the University of Pennsylvania. Dr. Wertheim completed his residency in Surgery at Massachusetts General Hospital. Following his residency, he went on to complete a fellowship in Transplantation at the University of California, Los Angeles.