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The Biological Aspect
Despite treatments mentioned in the surgery portion of the website, a variety of new procedures and techniques are emerging. Rather than using in vitro tissue engineering, the implantation of a scaffold in vivo, with or without cells, is a new concept that would allow regeneration to occur with little or no additional manipulation. Healing time for this method is anticipated to be less than in vitro. However, scientists keep in mind the rigorous mechanical environment in active joints that makes cartilage regeneration challenging. Several bioactive molecules exist in living bodies that cannot be modeled well in vitro, which is another reason to use in vivo techniques where the cartilage will be regenerating in its natural environment. While the new methods that have been researched have their pros and cons, complete regeneration comparable to the healthy tissue has not yet been achieved. With time and research, the future of tissue engineering’s focus on obtaining total regeneration could result in a successful breakthrough, bringing relief to approximately one quarter of the adult population with cartilage injuries and disease.  In vivo implantation of a tissue engineered construct into a cylindrical defect on the articular surface. |
The Business Aspect
Apart from the biological aspect of tissue engineering, the business aspect is often considered a speed bump. Biological products, such as blood, vaccines, tissues, and cellular and gene therapies derived from humans, animals, and microorganisms are regulated by the FDA's Center for Biologics Evaluation and Research (CBER). There is no doubt that new products related to articular cartilage will require the use of biological materials, such as cells and various chemicals, that are regulated by CBER. As a result, the pathway to approval is expected to be long and difficult because CBER requires an extensive series of pre-clinical and clinical studies. Also, the manufacturing of medical devices, those often used
in implantation and as in vitro reagents,
are regulated by the Center for Devices and Radiological Health (CDRH). Tissue
engineered cartilage, as an implant, may also be regulated by the CDRH. A
medical product intended to promote public health must undergo several
checkpoints in order to be both safe and effective, and reaching this stage is
not easy, especially if a potential product is regulated by both CBER and CDRH.
 Though
current surgical procedures are inadequate for providing a long-term
biological solution, the Department of Biomedical Engineering at UC
Davis envisions a day when both autologous and allogeneic cell sources
can be used to tissue engineer biological constructs to replace diseased
articular cartilage.
The cells can be stem cells originating from either the patient's own
skin or from stem cell banks. The idea is to replace the use of
artificial components with biological tissue engineered in the lab.
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