S103: Remaining Hurdles and Potential Solutions in Realizing the Therapeutic Promise of iPSC - An Overview of Patent and Clinical Data
Poster Presenter
Liyang Lyu
Student
University of Macau Macao
Objectives
Eighteen years after induced pluripotent stem cells came into being, many technologies have b invented to bring the promising cells to bedside to help fight human diseases. However, it remains vague how far to fulfil the promise. The study analyzed global iPSC patents and clinical research status.
Method
Induced pluripotent stem cell (iPSC)-related patents an clinical data worldwide were collected from Derwent Innovation database and ClinicalTrials.gov. All data were searched according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement.
Results
As a result, 11,252 patent documents and 93 observational and interventional clinical trials for further analysis. Patents have shown rapid growth worldwide, while the number of clinical trials was relatively stable. We found that the increase of granted and commercially assigned patents, especially those related to iPSC differentiation. Intellectual property barriers reduced as reflected by industry partnerships, transparent commercial licensing and diversified portfolio.
Among the front runners, the United States (U.S.) was the most productive country with 4,435 patents, followed by Japan and China with 3,454 and 1,309 patents, respectively. The three countries owned the most applicants, accounting for more than 76% of global applicants, followed by Korea and UK, based on the analysis of assignees with residence in these countries or regions.
Given some hurdles remaining in the therapeutic applications of iPSCs such as tumorigenicity, immunogenicity, and heterogeneity, solutions have appeared via combination with other cutting-edge technologies such as genome editing and chimeric antigen receptor T/NK cells. Thus, despite of the lengthy time spent for the research and development of iPSC-related technologies, the hope is truly coming to manifest their therapeutic power.
Conclusion
The potential of human pluripotent stem cells in cell therapies and other applications is vast. Currently, cell therapies for over 14 diseases and injuries have either reached or are on the brink of reaching clinical trials. The continuous progress of iPSC technologies, as evidenced by the growing number of global patents, presents a revolutionary approach to disease modeling, understanding, and treatment. iPSCs represent a paradigm shift, facilitating the direct establishment, expansion, study, and treatment of relevant patient cells. The emergence and ongoing innovation of technologies such as genome editing and 3D organoids, alongside anticipated advancements, will further expand and explore the applications of iPSCs. Despite being in its early stages and carrying significant biosafety risks, there remains a steadfast belief that the patent landscape of iPSC technologies will evolve as more applications for basic research and clinical use emerge in the future.
