New Progress of Research | the Clinical Trial Project of the World's First Stem Cell Innovative Drug for Ulcerative Colitis Start in the Affiliated Hospital of Qingdao University
Recently, the clinical test project of Human Umbilical Cord Mesenchymal Stem Cell Injection studied by the scientific research team of Qingdao Allcare Biomedical Development(ABMO) for patients with moderate and severe ulcerative colitis initiated a clinical trial in the Affiliated Hospital of Qingdao University, and subjects are recruited to the whole regions. The initial meeting was held as another research center after the launch of the clinical trial of Peking University Third Hospital, providing subjects with more options and accelerating the marketing process of drugs, and bringing new hope for the treatment of patients with ulcerative colitis.
The sponsor of this project is ABMO. Leadingpharm is the contract research organization. Peking University Third Hospital and Qingdao University Affiliated Hospital are the two of the center. Professor Shigang Ding, Professor Zhibin Tian and Director Yu Cao, as the main investigators (PI) of the project, leading the project into the clinical trial phase.
New stem cell therapy for ulcerative colitis will start clinical trials
Ulcerative colitis is a chronic non-specific inflammatory bowel disease with unknown etiology and is recognized as one of the refractory diseases by the World Health Organization. Research data showed that the incidence of the disease is high and especially high in young adults. Due to its unknown etiology and complex mechanism, it lacks specific treatment. Traditional treatments are not stable effective and usually require surgical resection. In the case of ineffective drug treatment, the Affiliated Hospital of Qingdao University proved that mesenchymal stem cell therapy (80 patients enrolled) was as efficient as 87.5% by 3-month follow-up of the research of stem cell clinical project.
According to the National Drug Administration Drug Evaluation Center (CDE), ABMO obtained clinical trial implied permission for Umbilical Cord Mesenchymal Stem Cell Injection on July 14,2020, which is a new stem cell drug for severe ulcerative colitis , and the clinical trial started on December 7,2021 in Qingdao university hospital. ABMO, as the only stem cell declaration enterprise in Shandong province, obtaining clinical approval means that it will benefit patients and help Healthy China.
Strengthen the Integration of Industry, University, Research, Application , and Medicine to Promote the Transformation of the Stem Cell Industry
This drug provides a new method for the treatment of ulcerative colitis, which is not only expected to achieve the breakthrough of innovative stem cell drug in ulcerative colitis in China, but also is the first in the world. The target product of the drug is "human umbilical cord mesenchymal stem cell injection", which is just located at the connection point in the industrial chain between upstream of mature cell storage and downstream of blank clinical treatment.This can stretch the industrial chain of China's cell industry. At the same time, the research and development for the mesenchymal stem cell preparations can provide valuable first-hand information for industrialization production process, quality control, clinical application standards, and for other uses of stem cell preparations to provide relevant reference standards, so as to accelerate the industrialization of stem cell preparations in China and fully enhance the status and competitiveness of China's stem cell industry in the international community.
Beijing Leadingpharm-Zhengzhou Deep Blue Ocean
Zhengzhou Deep Blue Ocean Biomedical is a well-known brand created by Beijing Leadingpharm in the field of clinical CRO. At present, over 500 clinical studies have been completed. 50 to 100 BE studies can be completed each year, as well as 10 to 20 clinical studies of class Ⅰ new drugs. The service areas include phase Ⅰ~Ⅳ clinical research, BE research and PK / PD with biological drugs, chemical drugs, Chinese medicine, medical devices and drugs for cell and gene therapy, and the indications are involved in tumor, blood, endocrine, digestive, neurology, cardiovascular and cerebrovascular, kidney/urinary and other fields.
Deep Blue Ocean 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 a new drug market goes on the market at home and abroad.