What is regenerative medicine?
Clinical procedures that aim to repair damaged tissue or organs, most often by using tissue engineered scaffolds and stem cells to replace cells and tissues damaged by aging and by disease. In some cases, medical devices are part of the therapeutic procedure.What is tissue engineering?
Tissue engineering can be defined as the use of a combination of cells, engineering materials, and suitable biochemical factors to improve or replace biological functions in an effort to improve clinical procedures for the repair of damaged tissues and organs. The first definition of tissue engineering is attributed to Drs. Langer and Vacanti who stated it to be "an interdisciplinary field that applies the principles of engineering and life sciences toward the development of biological substitutes that restore, maintain, or improve tissue function or a whole organ". The concept of "functional tissue engineering" was initially introduced by Drs. Van Mow and Savio Woo as their studies began to examine laboratory-made tissues to see if they can function as natural tissues do. See "The Emergence of Tissue Engineering as a Research Field"
What is cellular therapy?
Stem cell research offers unprecedented opportunities for developing new medical therapies for debilitating diseases and a new way to explore fundamental questions of biology. Stem cells are unspecialized cells that can self-renew indefinitely and also differentiate into more mature cells with specialized functions. Research on human embryonic stem cells, however, is controversial, given the diverse views held in our society about the moral and legal status of the early embryo. The controversy has encouraged provocative and conflicting claims both inside and outside the scientific community about the biology and biomedical potential of both adult and embryonic stem cells. From “Cells and the Future of Regenerative Medicine”
Certain clinical procedures make use of adult cells (from the patient or from another source) to enhance the recovery/regeneration of the structure and/or function of tissue and organs. As an example, a procedure is currently in a clinical trial to use a patient’s muscle-derived stem cells to treat urinary incontinence. Also studies are underway on the use of patient-derived stem cells to treat certain cardiac ailments.
What are medical devices (or what medical devices relate to regenerative medicine)?
According to the FDA a medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions such as pregnancy.
FDA has a classification system for medical devices that is made primarily on the level of risk to users/patients and, therefore, the level of FDA oversight needed to ensure that the device is safe and effective as labeled. Generally, but not always, this corresponds to logical risk evaluations.