New Future | aCGT and SAMS&SPPH launched a clinical study of stem cell therapy for post-hepatitis B end-stage cirrhosis

At 10 a.m. on October 28, 2021, Shanghai Quansheng Biotechnology Co., Ltd. (aCGT) and Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMS&SPPH) held a kick-off meeting of the project "Clinical Research on Umbilical Cord Mesenchymal Stem Cells in the Treatment of Post-hepatitis B End-stage Liver Cirrhosis" in the Memorial Conference Room of SAMS&SPPH.  A number of experts from SAMS&SPPH, including the main investigator of the clinical study, Professor Ou Lisheng, Secretary of the Party Committee, Professor Huang Xiaolun, Professor Qi Nianmin Chairman of aCGT, Professor Wang Hao, CEO of aCGT and relevant personnel of the clinical CRO company participated in the kick-off meeting.

The project kick-off meeting was successfully held

The party secretary of Ou Lisheng first delivered a speech, saying that stem cell therapy technology has been included in China's key research and development plan, and the state has formulated a series of relevant policies and regulations to encourage and support stem cell research.

Subsequently, Director Huang Xiaolun of the Hepatobiliary and Pancreatic Surgery Center and Cell Transplantation Center of SAMS&SPPH delivered a speech, focusing on the research plan of this stem cell clinical research project, which is a single-center, prospective clinical study, and 30 patients with post-hepatitis B end-stage cirrhosis were enrolled according to the inclusion criteria.

Then, Professor Qi Nianmin delivered a speech, saying that the aCGT will continue to strictly abide by the "Good Clinical Practice for Drugs" (GCP) and the "Measures for the Management of Stem Cell Clinical Research" (National Health Science and Education Development [2015] No. 48) and other national stem cell related policies and regulations, produce and prepare stem cell preparations that meet the requirements of GMP clinical grade, and provide professional third-party service organization support to escort the clinical research projects cooperated by the two parties, ensure the smooth development of the project and solve any problems in the implementation process in a timely and proper manner.

Finally, Professor Le Weidong summarized the meeting，including the clinical protocol design, trial process, investigational drug management, safety events, informed consent, stem cell preparation, etc..

Biotechnology empowers life

Hepaticcirrhosis is a progressive chronic liver disease caused by one or more causes and characterized by diffuse fibrosis, pseudolobules, and regenerating nodules of liver tissue.

Liver disease is a serious public health problem in China, and it is estimated that about 400 million patients with various liver diseases in China have persistent chronic liver injury that causes hepatocyte degeneration and necrosis, followed by irreversible fibrous scarring and hepatocyte nodular regeneration, so the basic pathological changes of liver cirrhosis are characterized by pseudolobular formation.

A large number of studies have confirmed that mesenchymal stem cells have shown safety and efficacy in a variety of diseases by regulating the tissue microenvironment, promoting tissue repair, and reducing inflammatory responses, with little side effects and good tolerance.

At present, it is believed that there are two main mechanisms of mesenchymal stem cell therapy for liver cirrhosis: one is the proliferation and transformation of functional hepatocytes, and the other is to improve the intrahepatic microenvironment through paracrine effects.

In particular, human umbilical cord mesenchymal stem cells are a class of adult stem cells with self-renewal and multi-directional differentiation potential, which have the characteristics of wide sources, convenient extraction, low immunogenicity and strong proliferative ability, and are a type of stem cells with great potential for clinical application.

Brief introduction of the project research institution

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital（SAMS&SPPH），Located by the side of the Huanhua River and adjacent to the Qingyang Taoist Templein Chengdu, China.SAMS&SPPH has 7058 employees and 1066 senior professional experts, with 200 individuals who have won a variety of talent titles at provincial and ministerial levels. Among the latter, there is one academician of the Chinese Academy of Sciences, 17 national talents, 4 young and middle-aged experts with outstanding contributions from the Ministry of Health, 45 candidates for special government subsidies of the State Council, 24 academic and technical leaders of Sichuan Province, 22 talents from the “Tianfu Emei Plan”and 12 talents from the “Tianfu Qingcheng plan”.

SAMS&SPPH is approved by the State to carry out all types of solid organ transplantations and other clinical interventions. It is also qualified as one of the national stem cell clinical research institutes and their associated projects. It has a complete range of disciplines. Including 7 clinical key specialties，34 provincial medical key disciplines，4 key laboratories in Sichuan Province，3 national secondary medicine laboratories of the State Administration of Traditional Chinese Medicine.

Asia Cell Therapeutics (Shanghai) Co., Ltd.

Asia Cell Therapeutics (Shanghai) Co., Ltd.（aCGT） is located in Shanghai "Thousand Talents Plan" Pioneer Park, in accordance with the requirements of national stem cell regulations and policies, specializing in stem cell preparation preclinical research/trial (pharmaceutical research, pharmacodynamic research and pharmacology and toxicology research, etc.), human clinical research/trial, IND/NDA registration declaration and industrialization.

With the support of the Shanghai Municipal Government, the company has established the "Shanghai Thousand Talents Plan Pioneer Park Regional Cell Preparation Center", with 800 square meters of clinical-grade cell preparation workshop in line with GMP standards, which is an important basic platform for Shanghai's cell therapy industry, and currently mainly provides clinical-grade and traceable cell products for medical institutions and scientific research institutions.

The road is long and the line is coming, and the future can be expected. This kick-off meeting represents a new starting point, and the two parties of aCGT and SAMS&SPPH will work together on the development and application of stem cell drugs in the future, and are committed to bringing hope to more patients suffering from diseases.