2nd Annual Summit on ^{Cell Therapy, Tissue Science and Regenerative Medicine} November 9-10, 2018 Atlanta, Georgia, USA

Regenerative Medicine refers to a group of biomedical approaches to research and clinical applications which is aimed at replacing or "regenerating" human cells, tissues or organs to restore or establish normal functions which were damaged due to diseases. The field of Regenerative medicine has attracted much attention as it holds the promise of regenerating damaged tissues and organs in the body by replacing damaged tissue or by stimulating the body's own repair mechanisms to heal damaged tissues or organs. It also may enable scientists to grow tissues and organs in the laboratory and safely implant them within the body. Regenerative solutions thus can be a revolutionary step in the field of healthcare.

Stem cells are the fundamental units for achieving regenerative therapies thus these cells are gaining research and experimental focus for therapeutic screening as well as other interventions. The two most useful characteristics of a stem cell are perpetual self-renewal and the ability to differentiate into a specialized adult cell type. One of the most celebrated successes witnessed in use of stem cells in the field of regenerative medicine is the clinical implementation of bone marrow transplantation for regeneration of the blood-forming system.

Mesenchymal stromal cells have emerged as powerful tool for regenerative medicine field. Mesenchymal stem cells (MSCs) are a population of multipotent progenitor cells residing in bone marrow, fat, and some other tissues and can be isolated from various adult and fetal tissues.

Stem cell transplantation is a procedure in which diseased bone marrow (the spongy, fatty tissue found inside larger bones) is destroyed with chemotherapy and/or radiation therapy and then replaced with highly specialized stem cells that develop into healthy bone marrow. It is most often recommended as a treatment option for people with leukemia, multiple myeloma, and some types of lymphoma. It may also be used to treat some genetic diseases that involve the blood. Although this procedure used to be referred to as a bone marrow transplant, today it is more commonly called a stem cell transplant because it is stem cells in the blood that are typically being transplanted, not the actual bone marrow tissue.

Tissue engineering is widely used in the biomedical sector for regeneration and repair of diseased or trauma tissues. Tissue engineering addresses tissue and organ failure by implanting natural, synthetic, or semisynthetic tissue and organ mimics that are fully functional from the start or that grow into the required functionality. The field initially focused on skin equivalents for treating burns, but an increasing number of tissue types are now being engineered, as well as biomaterials and scaffolds are being used as delivery systems successfully. A variety of approaches are used to coax differentiated or undifferentiated cells, such as stem cells, into the desired cell type.

Scaffolds are one of the three most important elements constituting the basic concept of regenerative medicine, and are included in the core technology of regenerative medicine. Every day thousands of surgical procedures are performed to replace or repair tissue that has been damaged through disease or trauma. The developing field of tissue engineering (TE) aims to regenerate damaged tissues by combining cells from the body with highly porous scaffold biomaterials, which act as templates for tissue regeneration, to guide the growth of new tissue. Scaffolds has a prominent role in tissue regeneration designs, fabrication, 3D models, surface ligands and molecular architecture, nanoparticle-cell interactions. Porous form of the scaffolds are used in the field for regenerating different tissues and organs in the body.

Gene therapy uses genes to treat or prevent disease. In the future, this technique may allow doctors to treat a disorder by inserting a gene into a patient’s cells instead of using drugs or surgery. Several approaches to gene therapy are currently being tested by the researchers including: Replacing a mutated gene that causes disease with a healthy copy of the gene; Inactivating or “knocking out” a mutated gene that is functioning improperly; Introducing a new gene into the body to help fight a disease. Although gene therapy is a promising treatment option for a number of diseases (including inherited disorders, some types of cancer, and certain viral infections), the technique remains risky and is still under study to make sure that it will be safe and effective. Gene therapy is currently only being tested for diseases that have no other cures.

Researchers are developing animal models to study various aspects of regenerative medicine such as stem cell repopulation, recellularization, cellular mechanisms underlying limb and spinal cord regeneration etc.

Regenerative medicine attempts to augment the natural healing process to heal or even “grow back” the damaged tissue viz. muscle, tendon, ligament or cartilage etc. Surgical and non-surgical procedures are performed which are designed specifically to heal and “Regenerate” damaged tissues. 

Regenerative rehabilitation combines the principles and approaches from rehabilitation and regenerative medicine for developing innovative and effective methods to promote the restoration of function through tissue regeneration and repair. Regenerative medicine and rehabilitation together can contribute in several ways in patient treatment and care plans.

People with reconstructive needs due to aging, burn injuries, cancer, complex wounds, birth anomalies and other trauma injuries have very limited effective treatment options. Researcher and plastic surgeons are creating regenerative medicine therapies with the goal of both healing the damaged tissue as well as forming new tissue.

Cell therapies with short shelf-life due to a “fresh” final product (as the product is not designed for a long-term storage) are perfectly acceptable for proof of concept of the cell therapy. But when it enters late-stage development and then commercial production, different constraints arise. Thus a cryopreserved final product becomes a necessity when considering the possibility of a late-stage clinical or commercial product with potentially thousands of doses a year that are needed to be shipped to different hospitals all over a continent or the world.

Regenerative Medicine is growing and maturing steadily; however, there are many challenges that lie ahead. These include best cell source, most appropriate biomaterials, and reliable ways of expanding the cells and growing them in a three-dimensional environment (stem cell bioprocessing).

Clinical trials are research studies carried out with human subjects to evaluate the effects of health-related interventions on health-related biomedical or behavioral outcomes.

Translational research involves future clinical application of the ongoing regenerative medicine and cell therapy studies.

Cell therapies, stem cell therapies and regenerative medicine have faced much criticism from scientists, researchers, bioethicists. Much has been talked about the field but very small is done for resolving these issues.

North America has become the global leader in cell therapy market with 50 percent share in the global market as heavy investments are being made for the development and commercialization of cell therapy products. The regenerative medicine market in Asia-Pacific is growing at a faster rate as a result of the intensified Research and Development activity in Japan and South Korea. Governments of some countries like Canada, Japan, and the United States are creating programs, establishing centers of excellence, manufacturing infrastructure and research networks to facilitate the rapid and profitable commercialization of these products in order to reduce the cost of care for aging population. However, the market is hindered to some extent as viable manufacturing infrastructure that supports the mass production of quality regenerative medicine products is still lacking. Therefore, large-scale manufacturing units are needed for autologous cell therapy and combination therapy products to meet the growing market demand.