What if damaged or worn-out tissues and organs could be replaced with laboratory-grown ones? Or if our own cells could be guided not merely to heal damaged tissue, but to regenerate it?
Such ideas date back to 1901, but for decades they remained little more than aspirations because scientists did not know how to achieve the kind of regeneration seen in some animal species.
A landmark breakthrough at the end of the 20th century changed biology and revived interest in regenerative medicine.
Researchers in Scotland created the first cloned mammal, a sheep named Dolly. The ability to create a clone — an identical copy of an adult organism — demonstrated that mammalian body cells retain the information needed to create an entirely new organism.
Further experiments highlighted the potential of stem cells, undifferentiated cells found in tissues and organs that act as a reservoir, replacing cells that die.
The isolation of such cells in 1998, followed by the discovery that they could be multiplied in laboratory conditions and guided to develop specific identities, such as nerve or muscle cells, generated optimism that regenerative medicine could move from science fiction into clinical practice.
“Regenerative medicine seeks to do more than treat a disease. It seeks to repair, restore, replace or regenerate cells and tissues that have been damaged or are dysfunctional, with the goal of restoring their function,” Maria Roubelaki, professor of Biology and Applications of Regenerative Medicine at the National and Kapodistrian University of Athens Medical School, told To Vima.
Roubelaki is also president of the Hellenic Society for Gene Therapy and Regenerative Medicine.
Progress has been gradual
Despite early predictions that regenerative treatments would be developed relatively quickly, only a small number of therapies today meet the requirements to be classified as regenerative medicine treatments.
It is not coincidental that the first therapies to be developed and approved by the U.S. Food and Drug Administration (FDA) and/or the European Medicines Agency (EMA) initially focused on skin and later cartilage. These tissues are less complex than those found in internal organs.
Today, such treatments are classified as Advanced Therapy Medicinal Products, or ATMPs. They are used, among other applications, to help heal burns and repair joints.
Some involve cells taken from the patient, which are cultured and multiplied under controlled conditions and combined with appropriate scaffolds before being transplanted.
The broader field of regenerative medicine also includes other advanced therapies, including gene therapies, treatments using stem or somatic cells, and tissue-engineering products.
“These are complex therapeutic products subject to strict quality, safety and efficacy requirements,” Roubelaki said.
Some applications are already established. Hematopoietic stem-cell transplantation, for example, has been used for decades. There are also advanced cellular and gene therapies for specific diseases, CAR-T cell therapies for certain blood cancers, cell therapies for skin repair and other highly targeted applications.
Research into such treatments continues intensively around the world.
The problem with unproven treatments
But what do these scientifically developed therapies have to do with treatments offered at doctors’ offices, aesthetic centers and wellness centers in Greece?
“Absolutely nothing!” hematologist Achilleas Anagnostopoulos, a pioneer in hematopoietic cell transplantation, said in response.
The protocol used to collect blood stem cells for therapeutic purposes illustrates the difference.
Blood stem cells are the cells from which the white and red blood cells circulating in the body develop. They are found in the bone marrow, meaning that their collection for transplantation originally required a bone-marrow procedure.
To avoid discomfort for donors, a protocol was developed involving the administration of a growth hormone, usually for five days. This increases the number of stem cells circulating in the blood, allowing them to be collected from the bloodstream rather than directly from the bone marrow, Anagnostopoulos explained.
In other words, only very small numbers of stem cells are normally present in circulating blood, and the number is not sufficient to produce a therapeutic effect.
Anyone claiming otherwise is making a false claim, he said.
Protecting the name of regenerative medicine
Roubelaki said practices that use the language of regenerative medicine without meeting the necessary scientific and regulatory standards risk undermining a field that has already produced new therapeutic possibilities and is expected to play an even greater role in future medicine.
“The goal is not to approach innovation with suspicion, but to ensure that every new therapeutic approach is supported by scientific evidence, safety, efficacy and rigorous evaluation,” she said.
The distinction is therefore between regenerative medicine as a scientifically developed field and treatments that use its terminology without the evidence and regulatory standards required for genuine medical therapies.
