Advanced therapies, particularly those under the Regenerative Medicine and Advanced Therapy (RMAT) designation within the U.S. or as part of the Advanced Therapy Medicinal Products (ATMP) in many other regions, have shown promising clinical efficacy and are changing the paradigm for treating diseases and injuries. Recent advances in biomedicine are opening the door to new approaches, and treatment and prevention are being transformed by novel medicines based on genetic engineering, regenerative medicine, innovative cell-based therapies and tissue-engineered products, and combinations of a medical device with embedded cell or tissue components. Advanced therapies are now experiencing rapid progress fueled by scientific and technology advancements, providing new innovative opportunities for the treatment of diseases and injuries, especially for many of the world's most pressing diseases beyond the reach of traditional approaches.

Clinical translation and patient access to this broad class of therapeutics requires better defined and characterized products and more robust, reliable, and cost-effective manufacturing processes. These advanced therapy medicinal techniques can potentially restore diseased and injured tissues and whole organs. Since the inception of the field several decades ago, several regenerative medicine advanced therapies, including those designed for wound healing and orthopedics applications, have received Food and Drug Administration (FDA) approval and are now commercially available. There are an estimated 450 companies across the globe working on the development of gene therapies and more than 1,000 clinical trials underway worldwide, and some 20–30 new advanced therapy medicinal products filings are expected in Europe annually over the next 5 years. They hold one of the keys to making a reality of genuine revolution medicine. However, clinical translation from bench to bedside and patient access to this broad class of therapeutics requires better defined and characterized products and more robust, reliable, and cost-effective manufacturing processes.

The aim of this Special Issue is to bring together original research and review articles discussing advanced therapies, which sets out the achievements to date with this new group of products, the principal challenges to their development, some possible immediate ways ahead, and the longer-term options for integrating advanced therapies into more impactful healthcare systems that capitalise on the opportunities of personalised medicine and globally harmonized practices and standards.

Potential topics include but are not limited to the following:

• Regenerative medicine
• Gene therapy
• Immunotherapy
• Gene-editing
• Stem cell therapy
• Personalised medicine
• Tissue engineering
• Biomaterials
• Precision medicine
• Artificial intelligence in medicine
• Engineering / synthetic biology
• Healthcare policy