STEM CELLS, BETWEEN EVIDENCE AND SHAM

STEM CELLS, BETWEEN EVIDENCE AND SHAM

In the facilities of Bogota Health Secretary, in Ricaurte neighbourhood, there is a hidden place that one could not expect that exists in Colombia: the District Institute of Health Science, Biotechnology and Innovation (Instituto Distrital de Ciencia, Biotecnologia e Innovacion en Salud), also known as Idcbis. Besides having the only public umbilical cord blood bank in the country, the institute develop research in steam cells, one word with we have been bombarded with, but we don’t fully understand.
Without going too far, if we follow the soap operas in the television, is common to watch an advertisement of Teatrical, a skin cream publicized for three recognized actresses that claim that is the only one with “an Asian flower stem cells”. Also is possible that, years ago, in social networks like Facebook, we encountered an advertisement of Stem Tech, a series of dietary supplements that claimed to support “the release of adult stem cells from the bone marrow”.
Also, if we do a fast review in the last scientific advances, we found more than a thousand of papers about the stem cell potential to treat various diseases: from diabetes, heart ischemia, cartilage regeneration, certain leukaemias, and even Parkinson disease.
The truth is that this promise has been feed alongside the scientific evidence and the commercial scams. So much so in 2017, Invima and Societies Superintendence suspended Stem tech.
Even though the first time that there was a talk about the potential of this cells was 20 years ago, according to calculation of National Health Service (NHS) of USA at 2018 near to 1.43 billion of dollars have been spent in 400 different research lines. This not including Europe and Japan that now leads the field. So, why so much fuss about stem cells? Why see them as a panacea?
Doctor Ricardo Peña, PhD in Molecular Pharmacology and professor in Los Andes University, likes to explain it with a simple metaphor. Stem cells have two characteristics that make them really attractive: they can replicate a lot and, potentially, can convert in any type of cell. “It is like when you go to a kindergarten. You are a kid with too much energy that, also, can turn into anything: lawyer, astronaut or artist. But then you go to school and you like math more and later in the university, you study an engineering career. You specialize and is too difficult, if not impossible, becoming a child again”. Then the stem cells are like children full of energy to replicate and the potential to be anything that they want.
Precisely, this characteristics are the reasons why the stem cells are advertised to cure practically everything. The first thing that clarifies Ana Maria Perdomo Arciniegas, PhD in Biomedical Sciences of National University of Colombia, leader of the Idcbis bank and researcher for the improving of cell transplant, is that not all the stem cells are the same, and doesn’t have the same capabilities. Neither they come from the same tissues or are extracted from the same regions of the body. And despite that the science know a lot how and why they work, there are still a lot of questions to decipher.
A revolution that doesn’t fully comes
Stem cells – she says – can be classified by type: totipotent, multipotent and pluripotent. This words describe how little specialized are each cell and so their higher or lower capacity to turn in a cell of distinct tissues. To continue to Doctor Peña’s metaphor, we could say that is a way to classify the children: some are in kindergarten, other in preschool and other in primary.
Totipotent and pluripotent are foetal stem cells. This implies that, to use them, it is necessary to make inviable a foetus birth, which represent an ethical dilemma to scientific research. But the multipotent are cells that can be taken form umbilical cord or the amniotic liquid when a baby born, or even from adults. Because of that, this are the ones that have awaken science ambition.
In the deck of options, the one that have gained more fame are the hematopoietic stem cells; i.e. the cells that are in our blood. So much so there are more than 964,000 scientific publications about this kind of cells in Google Scholar. “More than 50 years ago the bone marrow transplant turned into the standard procedure to treat problems like leukaemia, lymphoma and other blood disorders”, explains in its web page the International Society of Stem Cell Research (ISSCR). Perdomo things that near 80 diseases can be treated this way.
But they are not the only competition. There are also the mesenchymal stem cells and the neuronal stem cells. The first have the potential to turn into bone, cartilage or fat cells or regulate the immune system. They can be extracted from different parts, like the proper bone marrow or the fat in our body. The second ones could, in theory, regenerate damages in central nervous system and, for example, achieve to return mobility to a person with irreparable injuries in the spinal cord. But here is where the research has less advanced.
From Perdomo’s eyes, also for the ISSCR, there is also too much to go down in this two fields. And is in this confusion between “the theory” of what this cells are capable of and what has been verified that they can do, where a giant door of scam has opened.
Bones that grows in the eyes
In March 2017, The New England Journal of Medicine published an unusual article. It was a mix between an alert call and a case study. At the hands of distinct ophthalmologist arrived three patients with exactly the same history: they came to an American clinic of stem cells to treat themselves a macular degeneration, a deterioration in the retina and that determines the precision in which we see. Everyone had stem cells injected in their eyes that were extracted from their own fat with the promise that they were capable to regenerate their vision.
But the effects were opposite. The vision of the patients worsened, had retinal detachment, haemorrhages and at the year of receiving the injection, the three of them have lost the capacity to perceive light. The story remembered the case that was reported by Scientific American at 2012.
A 60 year old women that lived in Los Angeles (USA) went to an aesthetic clinic in Beverly Hills for a liposuction and some face retouching. Three months later she wasn’t able to open her eyes. They were inflamed and she said hearing an uncomfortable “click” sound each time she blinked. When examining it, another medical team found something unbelievable. There were small pieces of bone in her eyelids and around the eye. Why? The aestheticians that made her liposuction took the opportunity to take from her fat mesenchymal stem cells (the same than can be modulated to generate bone or cartilage) and in a kind of “two for one” they injected them near her eyes to rejuvenate her eyelids.
The promise of the stem cells, for being near to the fiction of eternal youth and an infinite life, also has serve as an excuse for the appearing of endless treatment that are far to be approved. In USA the clinics offer treatments with stem cells that have proliferated to the point that Food and Drug Administration (FDA) has known very well how to put a stop to this.
In December 2018 the FDA wrote a letter to 20 of this clinics remembering them that they should be regulated under its guidelines and that should contact them before November 2020. That year, the documents said, the Agency will going to take strong actions against those who do not comply the parameters. A lot of clinics, however, answered them that they only inject stem cells extracted from the same patients so they don’t need any regulation. They say that there is no medication.
Because of this for Doctor Perdomo, one of the reasons that there currently exists more scams that real treatments is poor regulation, both in USA and Colombia. The science, as technology, usually go many steps ahead of law and those loopholes sometimes translate in false promises to patients.
In Colombia, as answered by Ministry of Health to El Espectador, the only approved treatment with stem cells are “Hematopoietic precursor transplants done with umbilical cord, bone marrow and peripheral blood stem cells for the treatment of blood dyscrasia or primary immunodeficiency”. From there on, everything have glimpses of essay and error.
In the edge of testing with stem cells
In the fourth floor of Altos del Bosque building, at the north of Bogota, Cell Regeneration Medical Organization facilities are found, lead in Colombia by Doctor Felipe Torres. Unlike Icdbis, what is done inside this walls is closer to the edge of experimental, but as Torres clarifies, “based on previous evidence”.
The centre offer what they call a “mixture of three concepts”: cell therapy, regenerative therapy and translational medicine, which often works with stem cells. In short words, they make alliances with international laboratories and research centres and, in some way, replicate successful procedures.
Torres, for example, is already treating patients with Parkinson disease with stem cells. But he always explains to them that this are experimental processes, “off label”, “not approved, but with successful researches in other countries”.
“In Colombia as long as the treatment is not part of the Benefits Plan is considered experimental or not approved. We chose patients that are not responding to other treatments and we explain to them that this therapy has minimum or international evidence”, he comments.
He also clarifies that unlike what happens with other drugs, the stronger evidence that commonly have vanguard treatments with stem cells are the case studies or clinic cases. What he refers to? Meanwhile to probe the efficiency of a headache drug, as acetaminophen, a population of 1000 people is used, for the pathologies that Torres works with, and for the ones that use stem cell, the matter is different. “Much of our patients come with orphan diseases, groups that doesn’t represent even the 6% of the global population, so doing wide clinical studies is really difficult”, he says. “Sometimes there are no huge researches that say if it works, but they evidence an improvement on quality of life, and when the patient have nothing else to do, is a big possibility”.
EL UNIVERSAL – COLOMBIA, PIONEERING IN LATIN AMERICA IN CELL REGENERATION
The research team is led by Doctor Felipe Torres, director and coordinator of Cell Therapy and Stem Cells in Latin America that alongside a team of specialist, have dedicated to study and find a treatment for patients with autoimmune, degenerative and post-traumatic diseases, as multiple sclerosis, lupus, diabetes, arthritis, polymyositis, retinitis pigmentosa, arthrosis, Alzheimer disease, Parkinson disease, vascular dementia, among others.
“Cell regeneration medicine rise as a need of the patients to find a last technology therapy, with an interdisciplinary point of view, where difficult development pathologies can be handled that currently are incurable by the actual methods, and with therapies with rare side effects”, pointed out Torres.

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