The Guangdong Provincial Department of Science and Technology recently officially released the 2021–2022 Application Guidelines for the "Precision Medicine and Stem Cells" Key Special Program of Guangdong's Key Field R&D Plan (Draft for Comments).
In accordance with the requirements of the Several Policy Measures on Promoting Innovative Development of the Biopharmaceutical Industry (Yue Ke She Zi [2020] No. 86) and the Guangdong Action Plan for Developing the Biopharmaceutical and Health Strategic Pillar Industry Cluster (2021–2025) (Yue Ke She Zi [2020] No. 218), and combining Guangdong's R&D foundation in precision medicine and stem cells, the Guangdong Provincial Department of Science and Technology, after research and demonstration, has formulated the 2021–2022 Application Guidelines for the "Precision Medicine and Stem Cells" Key Special Program of Guangdong's Key Field R&D Plan (Draft for Comments).
This special program targets major diseases that are common, high-incidence, and locally characteristic in Guangdong. Oriented toward clinical application, it implements full-chain collaborative research in precision medicine, advances next-generation life omics technologies and big-data analytics, builds systems for precision-therapeutic target discovery and drug screening, conducts research on precision strategies for the prevention, diagnosis, and treatment of major diseases, and develops a series of precision-therapy drugs, molecular detection technology products, and instruments and equipment, so as to elevate Guangdong's research level and capabilities in independent innovation and translational application in stem cells and regenerative medicine.
The 2021 "Precision Medicine and Stem Cells" special program establishes 4 sub-themes with 17 research directions, and adopts the "competitive solicitation" approach to select outstanding research teams and outstanding projects. It plans to fund up to 20 projects.
Stem cell-related contents in the draft are as follows:
Direction 1: Construction Technologies and Applications of Complex Organoids Based on Stem Cells
Research content: Use pluripotent stem cells or adult stem cells to establish technical systems for constructing organoids (of pancreatic islet, neural, intestinal, hepatic, pulmonary, renal, reproductive, and other important tissues), and evaluate their applications in disease modeling, drug screening, and tissue/organ transplantation.
Performance indicators: Establish construction systems for no fewer than 3 types of organoids and construct complex organoids derived from multiple germ layers; systematically evaluate the structural features and degree of functional maturation of no fewer than 3 types of organoid tissues; elucidate key regulators and mechanisms in the formation of no fewer than 3 types of organoids; conduct disease modeling and drug screening using organoid models, and evaluate their efficacy in tissue/organ transplantation, obtaining no fewer than 3 lead compounds and no fewer than 3 application protocols; file at least 3 invention patent applications.
Application requirements: Enterprise-led applications and joint industry-academia-research applications are encouraged. Applications must cover all research content and performance indicators.
Direction 2: Identification of Functional Subpopulations of Tissue Stem Cells, Efficacy Evaluation, and Standard Setting
Research content: Investigate the heterogeneity of mesenchymal stem cells or neural stem cells, identify molecular markers and functional characteristics of stem cell subpopulations and their roles in maintaining tissue and organ homeostasis, identify functional subpopulations suitable for repair of injuries to different tissues and organs, develop standards for stem cell identification, production, and application, and conduct clinical efficacy evaluation.
Performance indicators: Identify molecular markers, functional features, and homeostasis-maintenance roles of no fewer than 3 types of tissue stem cell subpopulations; establish isolation, identification, and expansion systems for no fewer than 3 types of stem cell functional subpopulations; evaluate the therapeutic efficacy of these stem cell functional subpopulations in primate models; complete standards for 2–3 stem cell therapy products and obtain clinical research approvals for the transplantation of stem cell functional subpopulations to treat major diseases. File at least 3 invention patent applications.
Application requirements: Joint industry-academia-research applications are required. Applications must cover all research content and performance indicators.
Direction 3: Mechanisms and Translation of Stem Cell-Derived Extracellular Vesicles in Regulating Tissue and Organ Regeneration and Repair
Research content: Investigate the components, functions, and formation and secretion mechanisms of extracellular vesicles derived from various adult stem cells (mesenchymal stem cells, neural stem cells, etc.); for major diseases of the nervous, immune, metabolic, respiratory, and other systems, examine the safety, efficacy, and therapeutic mechanisms of extracellular vesicle therapy.
Performance indicators: Analyze the components of extracellular vesicles derived from at least 3 categories of stem cells, elucidating their formation and secretion mechanisms; clarify mechanisms by which extracellular vesicles promote tissue and organ regeneration and repair; develop efficient, rapid, and precise capture and enrichment technologies for extracellular vesicles, forming 2–3 industry standards or specifications; for one representative disease each in the nervous, immune, metabolic, and respiratory systems, evaluate the safety and efficacy of stem cell-derived extracellular vesicle therapy and obtain clinical research approvals for treating major diseases. File at least 3 invention patent applications.
Application requirements: Joint industry-academia-research applications are required. Applications must cover all research content and performance indicators.
Direction 4: Clinical Research and Product Development of Stem Cell Therapy for Acute and Critical Diseases
Research content: For acute and critical diseases such as acute respiratory distress syndrome, sepsis, and liver failure, establish manufacturing processes for stem cell therapy products; rely on national-filed stem cell clinical research institutions to conduct compliant preclinical and clinical research; develop stem cell therapeutics; and identify molecular markers for efficacy evaluation.
Performance indicators: Develop no fewer than 1 stem cell product certified by a nationally recognized institution; conduct systematic safety and efficacy evaluations of stem cell therapy for 1–2 diseases and obtain preclinical data sufficient to support entry into the clinical research stage; on the basis of completed clinical research filing, conduct compliant clinical research on stem cell therapy, identify 2–3 biomarkers usable for efficacy evaluation, and obtain clinical trial approvals for 1–2 stem cell therapy products. File at least 2 invention patent applications.
Application requirements: Joint industry-academia-research applications are required. Applications must cover all research content and performance indicators.
Direction 5: Product Development of Stem Cell Therapies for Major Refractory Diseases
Research content: Develop stem cell therapy products for major refractory diseases of the nervous, hematologic, motor, metabolic, hepatic, and immune systems, completing process development, pharmacodynamic evaluation, and clinical trials.
Performance indicators: Encourage and support applications with novel academic ideas, well-grounded rationale, clear research goals, specific research content, and reasonable technical roadmaps. Achieve breakthroughs in 1–2 core key technologies and propose a complete technical solution at the stage of clinical demonstration application; obtain at least 2 invention patents and provide at least 2 corresponding demonstration application evaluation reports. Obtain product marketing authorization.
Application requirements: Applications must be enterprise-led.
News source: Guangdong Provincial Department of Science and Technology (full content available on the website)
http://gdstc.gd.gov.cn/hdjlpt/yjzj/result/14555
