【Great news】aCGT and SAMS&SPPH jointly carried out stem cell clinical research institutions and stem cell clinical research projects, both of which have been approved by the National Health Commission!

In November 2020, 13 stem cell clinical research projects from 12 clinical research institutions including Guangdong Provincial People's Hospital，were completed and filed in accordance with the "Management Measures for Stem Cell Clinical Research (Trial)" (National Health Science and Education Development [2015] No. 48).

At this point, the number of stem cell clinical research filing institutions has increased to 111, and the number of filing projects has reached 100.

Among them, the stem cell clinical research project "Single-center, prospective clinical study of umbilical cord mesenchymal stem cell transplantation in the treatment of post-hepatitis B end-stage liver cirrhosis" jointly carried out by Asia Cell Therapeutics (Zhejiang) Co., Ltd. (aCGT), and Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital(SAMS&SPPH) has successfully obtained the "dual filing" of the project and the institution.

Stem cell clinical research filing institution

Stem cell clinical research filing project

The table is from China Medicinal Biotech Association

The mission of aCGT is to provide everyone with the right to a higher quality of survival. We provide new strategies to compensate for diseases that cannot be cured by existing medical methods through stem cell therapy.

1、Stem cells & Hepaticcirrhosis

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 cirrhosis usually has an insidious onset and a slow course of disease, and cirrhosis is clinically roughly divided into compensated and decompensated liver function.

Liver disease is a serious public health problem in China. It is estimated that there are about 400 million patients with various liver diseases in China, including 86 million cases (23.5%) of chronic hepatitis B virus (HBV) infection, 10 million cases (2.5%) of chronic hepatitis C virus (HCV) infection, 60 million cases of alcoholic liver disease, accounting for 15.0%, 200 million cases of non-alcoholic fatty liver disease, accounting for 50.0%, and 37 million cases of other liver diseases, accounting for 3.9%.

The basic pathology of cirrhosis is characterized by pseudolobular formation due to diffuse degeneration and necrosis of hepatocytes caused by persistent chronic liver injury, followed by irreversible fibrous scarring and nodular regeneration of hepatocytes.

Stem cells are a type of cells with multidirectional differentiation ability, which can migrate to the site of injury and differentiate into hepatocytes, and have the following functions:

1. Immunosuppressive function, inhibiting innate immune system response and adaptive immune response;

2. The function of secreting trophic factors and stem cells can directly inhibit the activity of hepatic stellate cells.

It has brought hope of recovery to many patients suffering from liver cirrhosis.

2、Stem cell quality

The successful filing of stem cell clinical research projects is inseparable from a high-quality stem cell foundation.

Since the end of 2017, CDE has begun to accept application for IND registration of stem cell drugs. Therefore, the testing methods and standards for stem cell quality have received widespread attention in the industry. Combining traditional GMP standards, new concepts of stem cell technology, and the particularity of biological preparations, relevant research institutions and companies lack quality references and standards. National Institutes for Food and Drug Control quickly established various inspection items and evaluation standards, and led the issuance of multiple guidance documents.

aCGT strictly follows a series of policies and regulations, such as the Administrative Measures for Clinical Research of Stem Cells, the Administrative Measures for Clinical Research and Translational Application of Somatic Cell Therapy (Trial) Draft for Comments, and the Technical Guidelines for the Research and Evaluation of Cell Therapy Products. Actively participate in the clinical transformation of stem cell technology and products, and devote himself to stem cell clinical research projects.

At present, the regulations stipulate that the stem cell products used in the human stem cell project shall obtain the quality inspection report issued by a third-party testing agency, and the Central Institute for Inspection and Inspection is the legal authority for testing the quality of pharmaceutical biological products

aCGT has passed the quality review by National Institutes for Food and Drug Control and obtained the Inspection Report , including SH202003392 , SH202003393, SH202003394.

3、Brief introduction of the project partners

Sichuan Provincial People's Hospital, the research institution of the filing project, has 6 national key clinical specialties (laboratory department, clinical nursing, nephrology, emergency medicine, intensive care medicine, clinical pharmacy), 4 key laboratories of Sichuan Province (human disease gene research, ultrasound medicine, clinical immunotranslational medicine, individualized drug treatment), 4 clinical medical research centers in Sichuan Province, 3 secondary laboratories of the State Administration of Traditional Chinese Medicine, and 34 provincial key medical disciplines. In recent years, it has won more than 1,500 scientific research projects at or above the department and bureau level, including 2 national key research and development programs. More than 500 patents have been authorized, and 57 patents have been implemented and transformed. It has won a total of 72 National Science and Technology Progress Awards and Sichuan Science and Technology Progress Awards, forming a strong advantageous discipline cluster and laying a solid foundation for scientific research and new technology development.

The sponsor of the project, Asia Cell Therapeutics (Shanghai) Co., Ltd. (aCGT), is located in the "Thousand Talents Plan" Pioneer Park in Shanghai. In strict accordance with the requirements of national stem cell related laws and policies. aCGT specializes in preclinical research/trial (pharmaceutical research, pharmacodynamic research, pharmacology and toxicology research, etc.) of stem cell preparations, human clinical research/trial, IND/NDA registration application and industrialization. With the strong support of the Shanghai Municipal Government, the company has established the "Shanghai Thousand Talents Program 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.

Through this study, the clinical treatment plan can be optimized, the data of stem cell therapy for liver cirrhosis can be accumulated, and the role of stem cells in anti-inflammatory, immune regulation and tissue damage repair can be verified, so as to accelerate the clinical application of mesenchymal stem cells.

Human beings have come to the era of "cell therapy", and we use "stem cells" to treat diseases, beauty, anti-aging, and manage health. In terms of disease treatment, cell therapy has provided new treatment options for more than 100 diseases, including tumors, and is considered a new promising treatment method after surgery, chemotherapy, radiotherapy, and targeted drugs, and is also a key area of global scientific research and clinical research.

In the near future, we hope to work together from multiple parties to promote the development of stem cell therapy technology and research in China, and to benefit more patient groups.