Regenerative Medicine is a rapidly evolving interdisciplinary field in health care that translates fundamental knowledge in biology, chemistry, and physics into materials, devices, systems, and therapeutic strategies which augment, repair, replace or regenerate organs and tissues. (Source: Alliance for Regenerative Medicine)

Regenerative Medicine, a term often used synonymously with Tissue Engineering, covers a wide variety of approaches to create living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. Regenerative Medicine also empowers scientists to grow cells, tissues and organs in the laboratory and safely implant them when the body cannot heal itself. Importantly, Regenerative Medicine has the potential to solve the problem of the shortage of organs and tissue available for use compared to the number of patients that require life-saving organ and tissue transplantation. (Source: National Institutes of Health)

Regenerative Medicine holds the promise of transforming the way researchers discover and produce medicines and the way providers deliver health care solutions. It represents a new paradigm in health care that will meet unmet medical needs by focusing on the underlying causes of disease. Numerous obstacles, however, hinder the field’s progress including: research challenges, access to capital, manufacturing, regulatory policies and reimbursement. For this field to reach its potential, a focused approach to identifying and overcoming scientific, regulatory, commercial, research and product development barriers, by leaders in the research and business community, is essential.

For more information, please visit:

• Alliance for Regenerative Medicine (http://www.alliancerm.org/)
• National Institutes of Health (http://www.nih.gov/about/researchresultsforthepublic/Regen.pdf)
• Tissue Engineering & Regenerative Medicine International Society (http://www.termis.org/)
• U.S. Department of Health & Human Services (http://www.hhs.gov/reference/newfuture.shtml)

Cell Therapy is the process of introducing new cells into a tissue in order to treat a disease, like Diabetic Foot Ulcers. There are many potential forms of cell therapy. One is the transplantation of cells that are autologous (isolated from the patient) or allogeneic (isolated from one individual donor that are used on other individuals).

Dermagraft®, for example, is an allogeneic cell preparation that allows the use of a single cell source for treating all types of people. The fibroblast cell line used in the manufacture of Dermagraft was derived from the foreskin of a single individual (newborn male) almost 20 years ago. The cells were used to create a master cell bank that has been extensively tested for safety, including the absence of any infectious agents.

To produce Dermagraft, individual vials of the fibroblast cells that were frozen as part of the cell bank are thawed, expanded in culture and then seeded onto the bioabsorable matrix used in the production of Dermagraft. After approximately two weeks, the cells have settled down onto the matrix and proliferated, thereby increasing the cell number present. At this time, they have also produced the collagen-rich extracellular matrix and associated growth factors, forming a living human tissue that can be used to stimulate tissue repair. The product is then stored frozen in a special buffer that allows the cells to retain their viability when the product is thawed at the time of use, yielding a living human tissue equivalent with proven ability to stimulate tissue repair.

For more information, please visit:

• http://www.dermagraft.com/

Tissue Engineering, a term often used synonymously with Regenerative Medicine (link to ABH page), is an interdisciplinary field that combines the principles of engineering and life sciences to develop biological substitutes that restore, maintain or improve function of a specific tissue or a whole organ.

While most definitions of tissue engineering cover a broad range of applications, in practice the term is closely associated with applications that repair or replace portions of or whole tissues (i.e., bone, cartilage, blood vessels, bladder, skin, etc.). Often, the tissues involved require certain mechanical and structural properties for proper functioning.

For more information, please visit:

• Tissue Engineering & Regenerative Medicine International Society (http://www.termis.org/)