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Biomedicine and Molecular Biology

Stem cells' slow advance in Europe

Advances in human stem cell research and their applications to so-called regenerative medicine are going slower than expected, although significant progress has been made, says a new report on the subject by the European Science Foundation. The report recommends, among other things, the continued public support for this research and the clarification of the legal landscape with respect to patents.

Malén Ruiz de Elvira | 6 de julio de 2010

Photo: Abraxas3d

Regenerative medicine promises to be one of the most fascinating, and most controversial, scientific advances of the century, says the European Science Foundation (ESF), in its report on the European perspectives on the scientific, ethical and legal aspects related to research with human stem cells. The 13 authors of the report, including Spain’s Flora de Pablo, of the Center of Biological Research of Spain’s National Research Council (CSIC), remind us that the opportunity to repair or replace tissues or organs that have lost their functions due to age, illness, damage or birth defects by using human stem cells raises deep ethical issues with a strong emotional component.

Therefore, the foundation aims to stimulate research efforts to develop stem cells for regenerative medicine applications and other benefits for patients while maintaining high ethical and safety standards.

Potential applications

Among the many potential clinical applications of stem cells are cardiac muscle repair after myocardial infarction, treatments for neurodegenerative diseases, including Parkinson's, improvements in wound healing and the replacement of damaged bone and cartilage tissues. Nor can its use in identifying new drugs in the laboratory be forgotten.

Overall, these are applications that have awoken a great amount of excitement and hope, but the results of early clinical trials have not met these heightened expectations. Experts convened by the ESF believe that the area of bone and cartilage repair will the first to move towards the stage of clinical application, in part because these tissues are more accessible and less complex than neural and cardiac tissues.

The emergence of induced pluripotent stem cells (IPs), derived from reprogrammed somatic cells, is the most significant innovation in recent years, the authors note. But their appearance raises the risk that they will be studied and used much more than embryonic stem cells because they are more readily available and pose fewer ethical problems in some countries. However, the reports’ authors point out that the safety problems are by far higher in iPS than in embryonic stem cells and that since their properties are not identical it remains necessary to study them both.

The emergence of induced pluripotent stem cells is the most significant innovation in recent years“Regenerative medicine is a promising area, but we need to understand the full picture of what it can provide. We must be careful not to limit research on the different types of stem cells,” says Aotui Hovatta of the Karolinska Institute, who chaired the report. “With more research we will know more about the basic mechanisms of stem cells and their risks and benefits.”

In addition to continuing to work with all existing stem cell types, especially in basic science, the recommendations of the experts also point to the need for continued public funding, including European funds, for research in this area. “Progress towards therapy would be faster if all European researchers had the same opportunities, provided that they understand the risks and benefits of this research well,” they report stresses while advocating that all European citizens have equal access to therapies wherever they happen to reside.

“The lack of common criteria and universal standards for the preparation of stem cells has greatly hindered progress,” reads the report's final recommendations. “In addition, the functional characterization of stem cells is limited by the available methods of in vitro differentiation. A complete understanding of the identity of stem cells and their characteristics is both urgent and necessary.”

Problems with patents

The report also points out the existence of problems with patents due to the complexity of the process to patent technologies related to human embryonic stem cells in Europe. The European Patent Convention is not clear that innovations can be patented without raising any ethical problems because patents can not be given to use human embryos for industrial or commercial objectives. What is unclear is whether the therapeutic use of stem cells would be considered “commercial.”

In general, the rules indicate that patents will not be granted if the invention is based exclusively on a method that requires the destruction of a human embryo, but it does not clarify whether a small set of cells (the blastocyst, a common source of stem cells) is considered an embryo or not. “We need clearer rules on patents in order to maximize the potential innovations based on the knowledge of stem cells,” says Hovatta.

REPROGRAMMINGThe report also includes an updated summary of the rules and laws in each European country as well as a list of the types of stem cells currently worked with: embryonic, fetal, adult, those derived from tissues, iPS and mesenchymal. These last ones are multiuse adult cells derived from a well-characterized population that can develop into fat, cartilage, bone, tendon and ligament, muscle, skin and even nerve cells.

While attempts to obtain stem cells by cloning have been greatly reduced due to the shortage of eggs and the fraud scandal of the Korean scientist Hwang, work on somatic cell reprogramming has increased. “At this stage we can not say if it will succeed in generating iPS cells safe for transplantation in clinical trials, but for now these cells represent a unique route for drug development and for studying hereditary diseases or those diseases related with the environment and aging,” says the EFS report.

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