Guangdong has released application guidelines for key special projects of “Precision Medicine and Stem Cells”, setting up a special product development direction for stem cell treatments for major refractory diseases!

Recently, the Guangdong Provincial Department of Science and Technology officially released “2021-2022 Guangdong Province Key Area R&D Plan “Precision Medicine and Stem Cells” Key Special Project Application Guidelines (Draft for Comments)”.

In accordance with the “Several Policies and Measures to Promote the Innovation and Development of Biomedicine” (Guangdong Science and Technology Society [2020] No. 86) and the “Guangdong Province Action Plan for the Development of Biomedicine and Health Strategic Pillar Industry Clusters (2021-2025)” (Guangdong Science and Technology Society [2020] 218), combined with the research and development foundation of Guangdong Province in the field of precision medicine and stem cells, and after investigation and verification, the Guangdong Provincial Department of Science and Technology has formed the “2021-2022 Guangdong Provincial Key Area R&D Plan “Precision Medicine and Stem Cells” Key Special Project Application Guidelines (Draft for Comments)”.

This special project will target Guangdong’s common, high-incidence, and local characteristic major diseases, guided by clinical applications, implement collaborative research on the entire chain of precision medicine, break through the new generation of life-omics technology and big data analysis technology, build a precision treatment target discovery and drug screening system, carry out precise research on major disease prevention, diagnosis and treatment plans, and develop a batch of precision treatment drugs and molecular detection technology products and instruments. Enhance the research level, independent innovation and translational application capabilities of stem cells and regenerative medicine in Guangdong Province.

In 2021, the “Precision Medicine and Stem Cells” special project will set up 4 topics and 17 research directions. It will adopt the method of “unveiling the list and taking charge” to select outstanding scientific research teams and outstanding projects, and plans to support no more than 20 projects.

 

The stem cell-related content in the opinion draft is as follows:

Topic 4: New Strategies and Clinical Practice of Stem Cell Treatment

Research direction 1: Stem cell-based complex organoid construction technology and application

Research content: Use pluripotent stem cells or adult stem cells to establish a technical system for organoids (important tissues such as pancreatic islets, nerves, intestines, liver, lungs, kidneys, reproduction, etc.), and evaluate its application in disease simulation, drug screening, and tissue and organ transplantation.

Assessment indicators: Establish a construction system for no less than 3 types of organs, and construct complex organoids from tissues derived from multiple germ layers; the system evaluation is no less than 3 Structural characteristics and functional maturity of various types of organ tissues; analyze the key regulatory factors and mechanisms in the formation process of no less than three types of organs; carry out disease simulation and drug screening through organoid models, evaluate their efficacy in tissue and organ transplantation, obtain no less than 3 lead compounds, and obtain no less than 3 application solutions; apply for more than 3 invention patents.

Application requirements: Enterprises are encouraged to take the lead and industry, academia and research institutes jointly apply. Project applications must cover all research content and assessment indicators.

Direction 2: Identification of tissue stem cell functional subgroups, efficacy evaluation and standard setting

Research content: Study the heterogeneity of mesenchymal stem cells or neural stem cells, discover the molecular markers, functional characteristics and role of stem cell subpopulations in maintaining tissue and organ homeostasis, discover functional subpopulations suitable for the repair of damage to different tissues and organs, formulate standards for stem cell identification, production and application, and conduct clinical efficacy evaluation.

Assessment indicators: Identification of molecular markers for no less than 3 tissue stem cell subpopulations, Functional characteristics and their role in maintaining tissue homeostasis; establish a system for the isolation, identification and expansion of no less than three functional stem cell subpopulations; evaluate the therapeutic effect of the above-mentioned stem cell functional subpopulations in combination with primate models; complete the standards for 2-3 stem cell therapy products and obtain clinical research approval for stem cell functional subpopulation transplantation to treat major diseases. Apply for more than 3 invention patents.

Application requirements:A joint application between industry, academia and research is required. Project applications must cover all research content and assessment indicators.

Direction 3: The mechanism and transformation of stem cell-derived extracellular vesicles in regulating tissue and organ regeneration and repair

Research content:Study the components, functions, formation and secretion mechanisms of extracellular vesicles derived from a variety of adult stem cells (mesenchymal stem cells, neural stem cells, etc.); explore the safety, effectiveness and therapeutic mechanism of extracellular vesicle 15 therapy for major diseases such as nerves, immunity, metabolism, and breathing.

Assessment indicators: Analyze the components of extracellular vesicles derived from more than three types of stem cells and reveal their formation and secretion mechanisms; elucidate the mechanism by which extracellular vesicles promote the regeneration and repair of tissues and organs; develop efficient, fast and accurate extracellular vesicle capture and enrichment technology, and form 2-3 industry standards; target nerve, immunity, metabolism, For each representative disease of the respiratory and other systems, the safety and effectiveness of stem cell-derived extracellular vesicle therapy were evaluated, and clinical research approval for the treatment of major diseases was obtained. Apply for more than 3 invention patents.

Application requirements:A joint application between industry, academia and research is required. Project applications must cover all research content and assessment indicators.

Direction 4: Clinical research and product development of stem cell treatment for acute and critical illness

Research content: Establish a production process for stem cell treatment products for acute respiratory distress syndrome, sepsis, liver failure and other critical and severe diseases, rely on nationally registered stem cell clinical research institutions to carry out compliant preclinical and clinical research, develop stem cell treatment drugs, and discover molecular markers for efficacy evaluation.

Assessment indicators: Develop no less than 1 stem cell product and obtain national approval Institutional certification; conduct systematic safety and effectiveness evaluation of stem cell treatment for 1-2 diseases, and obtain preclinical research data that can support entering the clinical research stage; carry out standardized clinical research on stem cell treatment on the basis of completing clinical research filings, discover 2-3 biomarkers that can be used for efficacy evaluation, and obtain clinical trial approval documents for 1-2 stem cell treatment products. Apply for more than 2 invention patents.

Application requirements:A joint application between industry, academia and research is required. Project applications must cover all research content and assessment indicators.

Direction 5: Product development of stem cells to treat major refractory diseases

Research content:Research and developmentComplete process development, efficacy evaluation and clinical trials of stem cell treatment products for major refractory diseases related to nerves, blood, movement, metabolism, liver and immune system.

Assessment indicators: Encourage and support project applications with novel academic ideas, sufficient basis for argumentation, clear research goals, specific research content, and reasonable technical routes. Break through 1-2 core key technologies, propose a complete set of technical solutions during clinical demonstration applications, obtain more than 2 invention patents, and provide more than 2 corresponding demonstration application evaluation reports. Obtain product marketing authorization.

Declaration requirements:Enterprises will take the lead in reporting.

News source: Guangdong Provincial Department of Science and Technology (enter the webpage to view the full content)

http://gdstc.gd.gov.cn/hdjlpt/yjzj/result/14555