Update in Cell Therapies

By Dr. Carlos Téllez Osorio

The transition in the epidemiology of diseases that affect Mexico, namely, the changes that have been observed among the main causes of disease and eventual death among its habitants, have reoriented the budgets destined by the health sector towards the development of plans of increasingly specialized attention. Consequently, higher operating costs need to be updated in favor of preventive medicine, which has the virtue of being cheaper.

However, the economic factor should not be the only reason to make modifications in the national health system, since it is essential to avoid conditions that affect humans and satisfy their right to health in the broadest sense of the word.

Conventional medicine provides priority treatments to counteract the symptoms of diseases, but in general terms it does not attend to the causes that originate them. Even less, it does not provide a viable resolution to improve the quality of life of patients. Hence it is eagerly sought to propose health initiatives so that patients can count on care for degenerative chronic conditions that unfortunately affect the Mexican people.

It is urgent to focus attention on compassionate medicine practices for some pathologies, innovative medicine for other cases, and regenerative medicine as a strong tendency of wellness as in different countries of the world, which drag a heavy economic burden to conduct their plans of public health. Certainly, regenerative medicine operates with high costs today, but technology advances rapidly and expenses will decrease over the years.

But other factors are required in addition to economics for regenerative medicine to progress substantially. Therefore, applying a legal framework and congruent regulations necessary for clinical research and protocols to be facilitated, always under a bioethical environment towards patients is essential. For more than a decade, Japanese authorities have been working on the health regulation that has allowed the development of advanced cellular therapies, with huge focus on regenerative medicine in patients who are eligible for these treatments and satisfactorily comply with the inclusion criteria for diverse studies.

Without trying to evade the requirements established for clinical research in humans, Japanese doctors and researchers can request their authorities’ approval for a regenerative medical product, for example, an intravenous application of mesenchymal stem cells. This means that as soon as it is demonstrated that a cell therapy is safe in a certain number of patients, it can be executed in more patients to demonstrate its effectiveness. It will be followed up; if satisfactory with documented evidence over an estimated time of 3 to 5 years. It then may be approved with a definitive sanitary registry.

Proceeding under a solid and responsible medical environment is the only feasible way to estimate the benefits of regenerative medicine, making it perhaps the most difficult obstacle to overcome in many countries. Non-profesional doctors and other opportunistic people have proliferated in the health sector that not only discredit this activity, but also slow their development and put patients at risk.

To be continued…