Stem cells are not a cure-all

Violation of research ethics, falsification of research results

The conference "Ensuring the quality of research on the application of cell therapy and cell products in Vietnam" was held today, September 20, in Ho Chi Minh City by the Department of Science, Technology and Training, Ministry of Health and Ho Chi Minh City Department of Health.

At the conference, Dr. Nguyen Tri Thuc, Deputy Minister of Health, assessed that research on the application of cell therapy and cell products is developing strongly.

Mr. Nguyen Ngo Quang warns of health risks when going abroad for stem cell treatment when only hearing about advertisements and consultations, without verifying effectiveness.

However, the Deputy Minister of Health also noted that research on the application of cell therapy and cell-based products is facing challenges regarding safety, quality, ethical violations in research, falsification of research results, and exaggerated advertising... Currently, developed countries mainly allow research and clinical trials of these methods, especially stem cells, while their application in treatment is strictly controlled.

Dr. Nguyen Ngo Quang, Director of the Department of Science, Technology and Training, said that research and development of new products, new techniques, new methods in general and research on the application of cells and cell products have initially introduced new protocols, new techniques, new products with potential, providing doctors with more options to apply to medical examination and treatment.

According to Mr. Quang, all countries have strict regulations on cell application research; there is a risk classification (low risk, medium risk and high risk) on issues related to cell research and cell application, development into drugs and commercial products.

Mr. Ngo Quang assessed that Vinmec and Tam Anh Hospital have invested systematically and strictly followed the application of stem cells in medicine.

Classification based on risk: whether the cells are autologous or allogeneic. When evaluating the dossier for permission to conduct clinical trials, human trials are also based on risk discrimination. Human studies, and before applying cell therapies to humans, must be reviewed and approved by the Ethics Committee in Biomedical Research.

Based on the research, the regulatory agency will give conditional approval, short-term approval. And immediately withdraw when the cell product is not safe, not effective. With stem cell products, most are currently conditional approval, very few products are officially approved.

"Many Vietnamese people are being advised to go abroad for stem cell therapy at great cost. But there are situations where they are actually participating in stem cell trials on humans, but the participants are not fully informed. This reality poses potential health risks and huge financial losses due to expensive services, but the reality is not as advised," Mr. Quang warned.

No "making things difficult" but need strict legal regulations

Also at the conference, Associate Professor, Dr. Nguyen Anh Dung, Deputy Director of the Ho Chi Minh City Department of Health, pointed out a series of common violations in the field of stem cells, such as the provision of medical examination and treatment services without a license to operate medical examination and treatment; medical examination and treatment without a certificate to practice medical examination and treatment; advertising medical examination and treatment services without a license to operate medical examination and treatment or a certificate to practice medical examination and treatment; advertising false information, exceeding the scope of expertise, without a certificate confirming the advertising content.

Mr. Dung suggested that the Ministry of Health should tighten the appraisal and licensing activities related to stem cell treatment; strengthen inspection and supervision. It is not about whether the regulations are more or less difficult, but it is necessary to be clear about the law, to license, manage and handle violations, creating conditions for those in need to access quality, truly effective cell therapy services and therapies.

Some opinions from research and treatment groups note that stem cell therapy can effectively support some diseases that cannot be treated by traditional methods, but the application of stem cells is very strict and stem cells are not a panacea as many unverified advertisements claim.

Receiving comments at the workshop, Mr. Quang assessed that, besides facilities such as Vinmec and Tam Anh Hospital that have invested systematically and strictly followed the application of stem cells in medicine; licensed facilities for tissue banking and stem cell preservation, creating access opportunities for patients and those in need, on social networks, there is still widespread advertising of services abroad for stem cell treatment; false advertisements about the ability to treat diseases with stem cells.

"In the coming time, there will be strict regulations on research on the application of cells and cell products, creating conditions for this scientific field to comply with legal regulations, develop in the right direction, and bring more practical results in caring for and protecting people's health," Mr. Quang affirmed.

At the conference, delegates from health departments, researchers, and treatment facilities discussed and proposed strengthening specific management of the quality of research on cell applications and cell products in Vietnam, to ensure science and ethics in research; ensure the safety and effectiveness of research on cell applications and cell products, and protect the rights of participants in stem cell research.

In particular, the Ministry of Health needs to inspect the quality of cells and ensure the quality of cells used in clinical trials. The quality of cells, cell products and the application of cell therapy on humans need to be strictly controlled for safety and quality.

Source: https://thanhnien.vn/te-bao-goc-khong-co-kha-nang-chua-bach-benh-185240920124142767.htm