Qualification of Clinical Studies Should Be Strictly Reviewed in China

“China should issue uniform technical standards, and implement strict qualification review.” Lately, at the stem cell translation research forum concerning “standards and rules of stem cell clinical studies”, Professor Zhongchao Han, Chairman of National Engineering Center of Cell Products and President of Beijing Health-Biotech (Group), expressed that it was very necessary to formulate technical standards and operating procedures of stem cell production and clinical translation as soon as possible.

Stem cell therapy, in short, is to transplant healthy stem cells into a patient’s body, so that the transplanted stem cells can stimulate and repair damaged cells in the human body and thus treat the disease. In recent years, basic and clinical translational researches in this life science field develop rapidly. However, stem cell therapy belongs to “a type of medical technology” which involves ethical considerations, and whose safety and efficacy still needs further validation through formal clinical trials.

According to Professor Zhongchao, stem cell products are viable cells with biological effects, whose production usually goes through several steps, including donor screening, tissue collection, cell isolation and enrichment or expansion, testing, preparation, and etc, and any mistake in any step can lead to abnormity of cell viability, and even pose a threat to the life and security of recipients. Currently, due to lack of regulation and temptation of high profits, many medical institutions have boldly conducted clinical studies of stem cell therapy.

Concerning this phenomenon, Professor Zhongchao believed that regulation in this field should be uniform and formal, and clinical trials of stem cell technology should be organized by health or pharmaceutical sectors, and China should set up a cell product approval center to examine all cell products and ensure their safety and quality.