On September 7, the kick-off meeting of the Clinical Trial Research Center of Human Umbilical Cord Mesenchymal Stem Cell Injection for Patients with Moderate and Severe Ulcerative Colitis was successfully held in the form of cloud video. This innovative drug will fill the gap of domestic special drugs, open up a new way for the treatment of ulcerative colitis, and is of great significance to enhance the status and competitiveness of China's stem cell industry in the world.
 

Professor Ding Shigang, director of the Department of Gastroenterology and doctoral supervisor of the Third Hospital of Peking University; More than 10 clinical research experts in gastroenterology, including Professor Tian Zibin, director and doctoral supervisor of the Affiliated Hospital of Qingdao University, Cao Yu, director of the institutional office, Ms. Huang Yuxiang, chairman and chief scientist of Qingdao Allcare Biological Development Co., Ltd., Mr. Du min, executive director and executive vice president, etc. Mr. Tao Xinhua, the Chairman of Leadingpharm, the contract research organization, Mr. Liu Kun, the executive vice president, and other project leaders attended the meeting.
 

As a major breakthrough in the research and development of stem cell innovative drugs in China, this drug has been highly valued by project sponsors, contract research organizations and heads of various institutions. Professor Ding Shigang, director and doctoral supervisor of the Department of Gastroenterology of the Third Hospital of Peking University, Ms. Huang Yuxiang, chief scientific officer and medical doctor of Allcare Biological, and Mr. Tao Xinhua, chairman of Beijing Leadingpharm, delivered speeches respectively.
 

Mr. Tao said that after 10 years of research and development, the innovative drug developed by Oak biology has filled the gap of domestic special drugs and opened up a new way for the treatment of ulcerative colitis. As a contract research organization, Leadingpharm will cooperate with all parties, carefully formulate a scientific and reasonable clinical trial scheme, and actively promote the clinical trial of the drug with high quality. Effectively promote the clinical transformation and application of scientific research achievements, and jointly make great contributions to great achievements in a great era.
 

Finally, under the joint leadership of Professor Ding Shigang, Professor Tian Zibin and director Cao Yu, relevant personnel in each section of the project introduced the implementation tasks in detail, and at the same time, we had an in-depth discussion on the project content, so as to lay a solid foundation for the smooth progress of clinical trials.
 

Project situation
 

Research significance:

The drug provides a new method for the treatment of ulcerative colitis, which is not only expected to achieve the breakthrough of Chinese stem cell innovative drugs in ulcerative colitis, but also the first in the world.

The drug is just at the connection point between mature upstream cell storage and blank downstream clinical treatment in the industrial chain, which can stretch the industrial chain of China's cell industry.

The research and development of mesenchymal stem cell drugs can provide valuable first-hand information for the establishment of industrial production process, quality control and clinical application standards of mesenchymal stem cell preparations in China, and provide relevant reference standards for subsequent application of stem cell preparations for other purposes, so as to accelerate the industrialization of stem cell preparations in China, fully enhance the international status and competitiveness of China's stem cell industry.
 

Project introduction:

The main component of human umbilical cord mesenchymal stem cell injection is human umbilical cord derived mesenchymal stem cells, which are pluripotent stem cells with high self-renewal ability and multidirectional differentiation potential. It can migrate to the colon, inhibit excessive inflammatory reaction in the human body by producing immune regulatory factors such as IDO and PEG2, and secrete cytokines such as VEGF and EGFR to repair damaged intestinal mucosal epithelial cells and better repair local damage.

The innovative drug will improve the quality of life, prolong the survival time and benefit more patients with ulcerative colitis plagued by diarrhea, pain and anemia for a long time.
 

Beijing Leadingpharm
 

Zhengzhou Marine is a well-known brand in the field of clinical CRO created by Leadingpharm. At present, more than 500 clinical studies have been completed, 50 ~ 100 BE studies and 10 ~ 20 clinical studies of class I new drugs can be completed every year. The service fields include phase I ~ IV clinical research, BE research and PK / PD of biological drugs, chemical drugs, traditional Chinese medicine, medical devices and cell and gene therapy drugs. The indications include tumor, blood endocrine, digestion, neurology, cardio cerebrovascular, kidney / urinary and other fields.

Zhengzhou Marine has set up Medical Department, Clinical Operation Department, Data Department, Quality Control Committee, Pharmacovigilance Department, Registration Department, Human Genetic Resources Management Committee and other departments. It can promote the development of clinical research and the transformation of clinical research outsourcing service with innovative service mode and multi-dimensional information technology, and provide customers with diversified R & D support and services, including phase I ~ IV clinical trials of innovative drugs and generic drugs, generic pharmacokinetic (PK / PD) clinical studies, in vivo and in vitro correlation studies (IVIVR), clinical research of medical devices and third-party inspection, etc., fully cover large and small molecular drugs, meet the clinical research needs of different types of enterprises, and open up the most critical bottleneck before the new drug market for customers at home and abroad.

At present, Marine has a highly professional clinical service team of more than 400 people, and has set up resident offices in more than 20 central cities such as Tianjin, Shijiazhuang, Wuhan, Changsha, Hangzhou, Zhengzhou, Shenyang, Dalian, Guangzhou and Xi'an. It has established cooperation with nearly 1000 pharmaceutical clinical institutions and more than 600 clinical hospitals in China, such as the first hospital of Peking University, Beijing Anzhen Hospital, Beijing Fuwai Cardiovascular Hospital, Shanghai Changhai Hospital, Zhongshan Hospital Affiliated to Fudan University, Jiangsu Provincial People's Hospital, China Japan Friendship Hospital of Jilin University, the first Hospital Affiliated to Harbin Medical University, Guangdong Hospital of traditional Chinese medicine The First Affiliated Hospital of Tianjin University of traditional Chinese medicine and other cooperative hospitals have more than 1500 departments.
 

The successful holding of this kick-off meeting marks that human umbilical cord mesenchymal stem cell injection has officially entered the stage of clinical recruitment. Beijing new leader will go all out to cooperate with all parties to promote the development of China's pharmaceutical industry and contribute to the realization of the healthy China dream!
 

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