Stem cells: Can treatment be dangerous? – 07/25/2023 – Balance and Health

Underground clinics selling stem cell treatments are popping up everywhere. There are hundreds of them around the world, claiming they can cure everything from autism to cerebral palsy.

The greatest concentration of stem cell treatment clinics is found in the United States, Mexico, India and China. And people are traveling great distances to get these treatments, spawning a phenomenon known as stem cell tourism.

Despite warnings from scientists, the press and regulators that these treatments are untested and potentially dangerous, desperate people are shelling out thousands of dollars to essentially serve as guinea pigs for treatments that are not scientifically proven.

In the United States, several patients have lost their sight after undergoing stem cell treatment for degenerative eye conditions.

The patients, who were seen at an unregulated stem cell treatment clinic in Florida, paid up to $20,000 to participate in the “clinical trial”.

Other reports have highlighted serious harms associated with unregulated stem cell treatments, including fever, infections, tumors, brain inflammation, potentially deadly blood clots, disability and even death.

How stem cells work

Some parts of the human body have the remarkable ability to regenerate and replace injured or lost cells.

Human skin, for example, completely renews itself every four weeks. Red blood cells are completely replaced in about four months. But unfortunately, some organs are less efficient or unable to regenerate.

This self-repair or regeneration is a primary function of stem cells. Unlike other cells in our body, stem cells have the unique ability to transform into different types of cells, each serving a specific function.

In early human development, stem cells are called pluripotent, which means they can develop into any type of cell in the body.

But as the embryo develops, the stem cells become more specialized and can only develop into certain types of specific cells. And in adult humans, these specialized stem cells are called adult stem cells.

Adult stem cells are not as versatile as embryonic stem cells because they can only transform into cell types similar to their source. Stem cells found in bone marrow, for example, can only turn into blood cells, whereas brain stem cells can only replace brain cells.

In addition to their function of replacing specific cells, all stem cells collaborate with the self-healing of cells and organs, releasing beneficial substances stored in small droplets of lipids, called extracellular vesicles.

Stem cells have great potential for research and medical treatments, as they are able to help repair damaged tissues and organs in the body. In fact, thousands of legitimate clinical trials are underway to explore its healing potential.

But it’s still early days, and only a few stem cell treatments — for a limited number of conditions — have yet been approved by drug regulatory agencies such as the FDA in the US or the EMA in the European Union.

Stem cell therapies approved in the US include those aimed at specific types of cancer, receding gums, cartilage degeneration and spinal muscular atrophy. In all of these approved treatments, very specific types of stem cells are used for each condition.

Overall, stem cell treatment is still at a very early stage and is certainly not a general-purpose therapy or a miracle cure for every disease or condition.

Any clinic that offers stem cell treatments without regulatory approval is selling unproven and potentially dangerous therapies.

legal loophole

In the European Union and the United Kingdom, some clinics are acting unethically and taking advantage of a regulatory loophole.

If the stem cells are not modified in any way after they are extracted and then reinserted into a person, these procedures are not subject to the regulation of so-called advanced therapy drugs (drugs based on genes, tissues or cells).

As a result of this lack of regulation, there are no quality control standards—if quality control exists at all. Therefore, it is not possible to guarantee the effectiveness and safety of these stem cell treatments.

To convince potential customers that their stem cell injections work, many of these companies avoid referencing credible scientific evidence, such as randomized controlled trials — the gold standard for testing new treatments.

Instead, they fall back on evidence that has some medical and scientific basis but has been taken out of context.

Often these clinics use patient testimonials—written or videotaped—that cannot be verified. Or they mention celebrities who were treated at the clinic, using their fame and influence to create a sense of legitimacy despite a lack of scientific evidence or regulatory oversight.

Due to the lack of regulation and undisclosed quality control measures at these stem cell clinics, the risks of dangerous side effects and complications are significant.

Stem cell treatments that are not scientifically proven can also cause patients to postpone or give up treatments that are proven to be safe and effective for their conditions. These delays can have serious consequences, as they may allow the underlying condition to progress or worsen in the absence of appropriate medical intervention.

* Darius Widera is Professor of Stem Cell Biology and Regenerative Medicine at the University of Reading, UK.

This article was originally published on the academic news site The Conversation and republished under license Creative Commons. Read the original version (in English) here.