![]() Relying on the natural abilities of stem cells, researchers have used their biological mechanisms for stem-cell-based therapy. Stem cells provide therapeutic effects which improve physical development by regenerating damaged cells to assist in organ recovery. Stem cells are a group of immature cells that have the potential to build and recover every tissue/organ in the body due to their unique proliferative, differentiation, and self-renewal abilities. In recent years, different alternatives have been introduced for cell therapy in order to resolve these limitations, including the improved application of stem cells for the restoration of tissue, such as the combination of cells with scaffolds, cell cultures with suitable biochemical properties, gene editing, and the immunomodulation of stem cells, as well as the use of stem cell derivatives however, the use of these alternatives clinically may be postponed, as more preclinical studies are required due to their status as newer technologies. However, various studies have indicated that cell therapy is restricted by a few limitations. The main concept of regenerative medicine is implied tissue/organ regeneration using cells and, to reach this target, different kinds of cells have been used. Regenerative medicine is now regarded as an alternative to traditional drug-based treatments by researchers who study its potential applications in various diseases, including degenerative diseases, among others. Since the discovery of stem cells and the spread of awareness regarding their unique properties, they have been defined as therapeutic agents for organ and tissue repair, and so are widely considered good candidates for regenerative medicine, due to their many potential applications. Regenerative medicine is a multidisciplinary field including cell biology, genetic, biomechanics, material science, and computer science, the ultimate target of which is returning normal function to defective cells and tissues. Regenerative medicine is considered a promising new source of treatment for untreatable diseases in modern science. Moreover, we review, summarize, and discuss regenerative medicine clinical trial studies registered on the website. We address some required guidelines for clinical trial approval, including regulations and directives presented by the Food and Drug Administration (FDA) of the United States, as well as those of the European Medicine Agency (EMA). This review seeks to familiarize the reader with the process of translation from an idea to clinical practice, in the context of stem cell products. The translation of these new therapeutic products from the laboratory to the market is conducted under highly defined regulations and directives provided by competent regulatory authorities. In recent years, encouraging findings in preclinical studies have paved the way for many clinical trials using stem cells for the treatment of various diseases. ![]() Due to their pleotropic therapeutic potential through the inhibition of inflammation or apoptosis, cell recruitment, stimulation of angiogenesis, and differentiation, stem cells present a novel and effective approach to several challenging human diseases. Regenerative medicine is a new and promising mode of therapy for patients who have limited or no other options for the treatment of their illness.
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