Combination Products and Tissue Engineering - Report Example

Combination Products and Tissue Engineering What is a combination product? A combination product is any product that is comprised of two or more components that are combined together chemically, physically, or otherwise and then is produced as a single product. A combination product can also consist of two or more products that are in the same package and sold as one unit or as two or more products that are not actually packaged together, but that are directed to be used together as one on the packages. In any case, combination products consist of combinations of device and biological products, drug and device products, drug and biological products, or all three components. Provide some examples of combination products from different categories. Explain why they are combination products. According to the Insight Report when referring to different types of examples of combination products (2005, pg. 1), “Some examples of Combination products include: Drug-eluting cardiovascular stents, pre-filled syringes and insulin injector pens, monoclonal antibodies combined with chemotherapeutic drugs etc. Examples of products that don’t qualify as combination products include: Drug-drug, device-device or biologic-biologic combinations, general drug or biologic delivery devices (unfilled syringe or infusion pump) not intended to be used with a specific drug or biologic, in vitro diagnostic tests etc.” These items are combination products because they meet the definition, which is “Combination products are basically combinations of any of the following type: Drug-device, biologic-device, drug-biologic and drug-device-biologic. They can be physically or chemically combined, co-packaged in a kit or be separate, cross-labeled products” (Insight Report, 2005, pg. 1). What is tissue engineering? According to the Advanced Technology Program when referring to the field or practice of tissue engineering (2005, pg. 1), “Dramatic advances in the fields of biochemistry, cell and molecular biology, genetics, biomedical engineering and materials science have given rise to the remarkable new cross-disciplinary field of tissue engineering. Tissue engineering uses synthetic or naturally derived, engineered biomaterials to replace damaged or defective tissues, such as bone, skin, and even organs.” Tissue engineering is comprised of several different technologies. Animal and human cells are cultured in bulk, and these include cells from bone, cartilage, endothelial, marrow, muscle, skin, and stem cells. The idea is that the culturing of these cells may allow scientists to replace damaged tissues in humans to make them work properly again (ATP, 2005). Scaffolds can be created from either natural or synthetic products, placed in the body, and serve as a “template that allows the body’s own cells to grow and form new tissues while the scaffold is gradually absorbed” (ATP, 2005). The production of insulin requires pancreatic beta cells and they may be encapsulated in engineered biomolecular cages that allow them to function normally in a foreign host without triggering immune responses” (ATP, 2005). Implants may be subject to adhesion, but biocompatible polymers may be created to prevent this from occurring. Cells, tissues, and organs from transgenic animals may be used for xenografts (ATP, 2005). “Tissue engineering potentially offers dramatic improvements in medical care for hundreds of thousands of patients annually, and equally dramatic reductions in medical costs (ATP, 2005). Read the attached article Mending Broken Hearts then compare this technology to the drug-eluting stent. What are the advantages of the “living patch” approach over the DES approach? The living patch is a living patch of heart tissue that scientists hope to be able to affix over heart infarcts, which are scars that are left on the cardiac wall after a person has a heart attack and that are often vulnerable to rupture and/or cause deterioration of the heart. The patch is created in vitro using both natural and synthetic components. The idea is to populate a nourishing scaffold with living cells, affix the patch over the infract, and then for the patch to ‘grow into’ the scarred area as the scaffold dissolves (Cohen and Leor, 2004). According to Angioplasty.org (2008, pg. 1), “Sometimes referred to as a “coated” or “medicated” stent, a drug-eluting stent is a normal metal stent that has been coated with a pharmacologic agent (drug) that is known to interfere with the process of restenosis (reblocking). Restenosis has a number of causes; it is a very complex process and the solution to its prevention is equally complex. However, in the data gathered so far, the drug-eluting stent has been extremely successful in reducing restenosis from the 20-30% range to single digits. There are three major components to a drug-eluting stent: Type of stent that carries the drug coating, Method by which the drug is delivered (eluted) by the coating to the arterial wall (polymeric or other), and The drug itself – how does it act in the body to prevent restenosis.” The living patch has several benefits over the drug-eluting stent. First of all, the stent just holds open a damaged area. The living patch actually repairs the damage. Even if someone has a drug-eluting stent, their infarct can still rupture. The living patch can prevent that from happening. The drug-eluting stent also does nothing to restore the functioning of the damaged area to the heart like the living patch does (Cohen and Leor, 2004). Some would say that comparing the DES to the “living patch” is akin to compare the space shuttle to the horse and buggy. Do you agree? Why or why not? The FDA will very shortly be asked to review similar technologies so if you were an FDA reviewer, what questions or concerns might you have regarding technologies like in vivo tissue engineering? I would tend to agree with that statement because of the reasons I noted above. The only concerns I would have as an FDA reviewer would be related to safety and ethical concerns. Since there is no precedent, however, I would definitely be interested in learning all the facts. Some consider the “dark side” of tissue engineering to be cancer. Explain why? Do you agree? What are the consequences and ramifications for the future? Since tissue engineering encourages cells to grow and cancer is the out-of-control growth of cells, one can easily see how taking it to far could cause something like cancer, so I definitely agree. This just means that a lot more research on tissue engineering needs to be done before it is relied upon on a widespread basis. We need to make sure it does way more good than it does harm. Read the article Brain, Repair Yourself. Neurogenesis, similar to angiogenesis, cardiogenesis, nephrogenesis, etc. are examples of in vitro tissue engineering. What might we be able to achieve using neurogenesis that we cannot yet achieve today? Why? Scientists hope that, using the information they have gathered through research and combining it with future research that they may someday be able to coax the brain to produce new brain cells to replace the ones that die or that are damaged. So far, there are no cures for brain injuries or brain disorders, which they hope to change. In the words of Gage (2003, pg. 48), “Although stem cell transplants have many advantages, switching on the innate capacity of the adult nervous system to repair itself would be much more straightforward. The ultimate vision is that physicians would be able to deliver drugs that would stimulate the brain to replace its own cells—and thereby rebuild its damaged circuits.” References “Combination Products, Part I.” Insight Report, 8(4), 2005. “ATP FOCUSED PROGRAM: Tissue Engineering.” Advanced Technology Program. 2008. Retrieved March 15, 2008, from http://www.atp.nist.gov/focus/tissue.htm Cohen, S. and J. Leor. (2004). Rebuilding broken hearts. Scientific American. Read More