Recently, the Guangdong Provincial Health Commission took the lead in establishing China's first provincial stem cell clinical research quality control center in China. Its purpose is to further strengthen the clinical research and management of stem cells and somatic cells, and to promote the research, development and application of stem cells and somatic cell therapy technology.
Its duties include:
(一) To undertake the daily routine work of clinical research of stem (somatic) cells.To formulate the working system and responsibilities of the quality control center for stem (somatic) cell clinical research. To be responsible for organizing and carrying out quality evaluation, technical guidance, technical training and consulting analysis of stem cell clinical research. To guide medical institutions to carry out stem (somatic) cell clinical research program design, project review, application and filing, project implementation, final evaluation and so on. Regularly report and analyze the progress, existing problems and suggestions of clinical research on stem (somatic) cells in the province.
(二) Organize to evaluate the quality of clinical research on stem (somatic) cells. To establish the quality control standard of stem (somatic) cell clinical research in Guangdong Province, to formulate the key points of quality control, such as preparation, quality inspection, storage, transportation, use and research scheme design, informed consent, subject enrollment, research implementation, subject follow-up, database management, adverse event management and so on. The quality evaluation of the documented projects shall be carried out not less than once a year. Entrusted to carry out clinical research and supervision of stem (somatic) cells.
(三) Carry out clinical data monitoring of stem (somatic) cells. To establish the clinical research database of stem (somatic) cells in Guangdong Province, to ensure that the clinical research projects of stem (somatic) cells are timely, standardized, complete and accurate in accordance with the research plan, to ensure the reliability, authenticity and integrity of the research data, and to promote the integrated application of clinical research data of stem (somatic) cells.
(四) Strengthen clinical research training and communication of stem (somatic) cells. To organize the promotion and implementation of clinical research policies on stem (somatic) cells, and strengthen the technical training of laws and regulations, academic review and ethical review. To organize and build a provincial exchange platform for clinical research and transformation of stem (somatic) cells, strengthen the communication of preparation, testing, clinical research, transformation and application institutions and industry associations of stem (somatic) cells, and promote the establishment of an alliance (center) for clinical research and transformation of stem (somatic) cells.
(五) To establish and improve the management norms and standards for clinical research of stem (somatic) cells. Summarize and sort out the national system and the practices of Guangdong Province, and organize the formulation and promulgation of clinical research management standards for stem (somatic) cells in Guangdong Province. Organize and guide the formulation of relevant industry standards, group standards and local standards.
The center is headed by Rong limin, director of the third affiliated Hospital of Sun Yat-sen University.
Other members include experts from medical academia and technical experts from the business community. The establishment of a stem cell clinical research quality control center in Guangdong Province is a positive and important measure, which is of great significance for promoting the standardized development of stem cell clinical research, ensuring patient safety and promoting medical science and technology innovation.
1、Standardize research behavior: the establishment of the center is expected to strengthen the supervision and guidance of stem cell clinical research projects, ensure that all studies comply with national and international ethical and regulatory standards, prevent illegal practices, and improve research compliance and ethics.
2、Improve research quality: through quality control and standardized processes, the center can promote the scientific nature of research methods, authenticity and reliability of data, help to produce high-quality research results, and accelerate the transformation of stem cell therapy from laboratory to clinical application.
3、Strengthen communication and cooperation: as a platform, the center can promote exchanges and cooperation among member institutions, share research results and technical experience, form an atmosphere of collaborative innovation, and promote the common development of stem cell research in Guangdong Province and even the whole country.
4、Ensuring patient safety: strict quality control of stem cell clinical research can minimize patient risk, ensure the safety and effectiveness of treatment, and enhance public trust in stem cell therapy.
5、Promote policy formulation and optimization: the operation of the center can also provide practical basis and data support for policy makers, help optimize laws and regulations related to stem cell research, and guide the healthy development of the industry.
The establishment of Guangdong Stem Cell Clinical Research quality Control Center is an important step to promote the progress of life science and medical research, which is not only conducive to the rigor and innovation of scientific research, but also has a far-reaching impact on protecting the rights and interests of patients and promoting the transformation of clinical application.