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Introduction of Stem Cell Clinical Research Institutions

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In October 2016, Peking University School of Stomatology was approved as a Stem Cell Clinical Research Institution (hereinafter referred to as "the Institution"), which is the only stomatological hospital first approved by the National Health Commission of the People’s Republic of China.

The Institution has strong capabilities in medical, education and scientific research, and has undertaken a number of projects in the fields of stem cell and regenerative medicine funded by international scientific and technological cooperation program and National Natural Science Foundation of China. These projects have achieved important results and also have relatively stable and sufficient project research funding support. The Institution is mainly responsible for the clinical research on tissue regeneration and immunotherapy of dental pulp, periodontal ligament, deciduous teeth, apical papilla, gingiva, jaw and other tissues in the areas of dental pulp disease, salivary gland disease and jaw defect disease.

The institution's stem cell clinical research project is included in the unified management of Drug Clinical Trial Institution of Peking University School of Stomatology with well-run management system and quality system, covering project application, audit, quality management, risk management, etc., and equipped with a number of medical personnel received national GCP training, so as to ensure that the clinical research conforms to The Standard for Quality Management of Drug Clinical Trials and The Management Measures for Stem Cell Clinical Research (Trial) Requirements.

In order to improve the ability of stem cell therapy and stem cell clinical research, the institution has established a professional stem cell treatment platform that meets the requirements of laws and regulations, including a clean level of stem cell examination room and stem cell operating room; established a perfect hospital quality management system and standard for stem cell preparation, and realized the rapid inspection and release of stem cell preparation within one hour; and the hospital internal quality of stem cell preparation. The equipment and facilities for quantity management are complete, which meets the requirements of Guidelines for Quality Management of Stem Cell Preparations in Hospital for Clinical Research on Stem Cells in Cooperation with Medical Institutions.

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