The proposal emerged from a workshop held on 8/9 to develop a research protocol, bringing together hepatobiliary and stem cell experts from several hospitals and research institutions.

Professor, Doctor Pham Manh Hung, former Deputy Minister of Health, highlighted Vietnam's high prevalence of hepatitis B virus infection, affecting over 10% of the population. He noted that hepatitis B treatment remains challenging, with the disease often progressing to chronic conditions, liver cirrhosis, or liver cancer. Liver cell damage in hepatitis B patients, he explained, is primarily caused by an overactive immune system attempting to eliminate the virus from liver cells, rather than direct viral destruction.

Mesenchymal stem cells are known for their ability to modulate immune responses and are being investigated for various diseases. Umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC) are particularly promising, offering an abundant source that can be collected post-birth and cultured for therapeutic use. For hepatitis B patients, these stem cells are hoped to regulate excessive immune reactions, thereby reducing inflammation and supporting liver function recovery. International research has explored hUC-MSC in patients with liver cirrhosis and liver failure, including those with HBV-induced cirrhosis.

Preliminary studies indicate the safety and good tolerability of transplanted cells, showing some improvements in liver function markers and inflammation. However, current evidence is insufficient to establish this as a standard treatment; large-scale randomized controlled trials are necessary.

Professor Hung noted the lack of consistency in current research regarding cell product standards, patient selection, treatment timing, dosage, infusion frequency, and efficacy evaluation criteria. He emphasized the need for multi-center research, suggesting an initial rollout at a few facilities before broader expansion.

Professor, Doctor Pham Manh Hung, former Deputy Minister of Health, at the workshop on 8/9 to develop a research protocol for using umbilical cord stem cells to support hepatitis B-induced liver cirrhosis treatment. Photo: Hospital provided

Doctor, Physician Mai Van Dien, Director of An Sinh Hospital, emphasized the need to define the "treatment window"—the optimal time when patients with decompensated cirrhosis could most benefit from this therapy. He proposed focusing research on HBV-induced decompensated cirrhosis patients with Child-Pugh scores ranging from 7 to 12, a scale used to assess liver function impairment. He suggested further dividing this group into two levels, 7-9 and 10-12 points, to identify which stage offers greater potential for stem cell benefits.

Professor, Doctor Nguyen Thanh Liem, Director of Vinmec Research Institute of Stem Cell and Gene Technology, suggested intervening during less severe stages of decompensated cirrhosis, when liver function retains recovery potential. He advocated for research into using appropriate, repeatable doses, rather than high initial doses, to mitigate high costs and potential complications.

Associate Professor, Doctor Pham Van Phuc, Director of the Stem Cell Institute, Vietnam National University, Ho Chi Minh City, affirmed that umbilical cord-derived mesenchymal stem cells are a suitable source for this research. He cautioned, however, that cell quality could vary across institutions due to differing umbilical cord sources and culture protocols, underscoring the necessity for product standardization.

"Cells for research must come from licensed tissue banks and adhere to strict manufacturing standards, such as GMP", Phuc stated.

Concluding the workshop, experts reached an initial consensus that the research should focus on three key areas: standardizing cell quality, accurate patient selection, and appropriate patient stratification. The research will specifically target patients in less severe stages of liver cirrhosis, rather than end-stage cases, to assess the potential for liver function improvement.

This initiative is currently in the protocol development phase, not yet involving human trials. The insights gathered from the workshop will be compiled and reported to the Department of Science and Technology to refine the protocol further and explore developing the research as a Ministry of Health project.

Le Phuong