In the early 21st century, the discovery of human stem cells sent shockwaves throughout the scientific community. Researchers envisioned the potential to mend damaged tissues caused by natural aging processes or disease.
A few years down the line, their aspirations are finally within reach. The United States Food and Drug Administration (FDA) regulates blood stem cell transplantation for the majority of cancers and various conditions affecting the blood and immune system. Pioneering research is currently under way, exploring the therapeutic potential of stem cells derived from umbilical cord tissue in addressing knee osteoarthritis, a condition characterized by the gradual deterioration of cartilage, as well as nerve-related complications stemming from diabetes.
However, the promise of stem cells came with a darker aspect.
Following the discovery of stem cells, unscrupulous clinics emerged rapidly, claiming they could revitalize aging skin, joints, and even treat severe conditions like Parkinson’s disease. Throughout the United States, numerous clinics have been offering stem cell therapies without a sufficient scientific basis to support their claims, despite the lack of FDA regulation on this matter, as of 2021.
As a phenomenon that gained momentum, the influx of companies transforming this space unfolded with unprecedented rapidity, according to a notable publication in 2021.
History appears to be repeating itself as a promising “miracle cure” – exosomes – emerges on the scene.
Exosomes are microscopic vesicles produced by cells to encapsulate proteins and genetic material for intercellular communication and delivery. While preliminary research on these enigmatic vesicles hints at a possible link to aging or cancer metastasis.
Research is ongoing, exploring novel treatments that span a range of applications, including exosome-based therapies, innovative approaches to addressing slow hair loss, and groundbreaking remedies for cardiovascular conditions such as coronary heart attacks, strokes, and degenerative bone and cartilage disorders. They’ve potential.
While some clinics are capitalizing on the growing trend of exosome therapy, others are also exploring the potential benefits of these tiny vesicles. By 2030, a precise forecast indicates that exosomes will revolutionize the skincare industry.
The issue? Although researchers have made significant progress in understanding exosomes, we still lack a comprehensive grasp of these tiny vesicles’ intrinsic nature, physiological impact on the human body, and potential adverse reactions. In a novel approach, these molecular packages resemble intricately wrapped “thrillers” – each containing a unique blend of organic compounds that can dramatically reshape cellular properties by activating or silencing genes in unexpected ways.
Studies have investigated numerous crucial matters. “A pressing need exists to establish guidelines protecting patients from severe risks associated with interventions grounded in minimal or nonexistent scientific evidence,” a group asserts.
Mobile Area Shuttles
In 1996, Dutch molecular scientist Graça Raposo made an unexpected discovery: the immune cells she was studying seemed to communicate with each other through minute vesicles. As she examined the cells under the microscope, she observed that upon exposure to various toxins, the cells absorbed the molecules, transported them to the surface of small vesicles within the cell, and then released the vesicles into the vast expanse of their surroundings.
By gathering the bubbles and releasing them onto various immune cells. Notably, they elicited a comparable immunological reaction within the cells, mimicking exposure to the toxin just moments before. Bubbles seemed to ferry information between cellular compartments in a seemingly orchestrated manner.
Initially considered to be the cell’s waste management system, researchers believed that exosomes functioned as cellular “garbage compactors,” encapsulating unwanted molecular debris within membranous vesicles for eventual disposal outside the cell. Researchers led by Raposo, however, made a groundbreaking discovery just two years later: they isolated exosomes derived from cells capable of naturally combating tumours in mice.
Curiosity about these enigmatic blobs suddenly surged.
Researchers found that most cells release exosomal “spaceships,” allowing them to package various molecules, including proteins and RNAs, which can influence gene expression by switching genes on or off. Despite extensive analysis, we’re merely just beginning to uncover the vast potential of what cargoes they will transport and how they will function organically.
Despite ongoing research, the specific functions of exosomes remain somewhat obscure. Cells on the brink of death may be sending distress signals to their counterparts, urging them to reinforce their immune systems and prevent similar demise. Tumor cells have co-opted the process to deceive nearby cells into assisting their progression and spread. Researchers suggest that in Alzheimer’s disease, abnormal protein aggregates may potentially be transmitted from one cell to another, facilitating the disorder’s progression throughout the brain.
While they appear robust in part due to their minuscule size and inherently erratic behavior. Measuring just a tiny fraction of the size of a crimson blood cell – roughly one-hundredth its dimension – exosomes prove notoriously challenging to capture, even with the aid of state-of-the-art microscopy techniques. Each type of cell exhibits a unique proliferation pattern, with some cells rapidly dividing and releasing numerous progenies at once, while others proceed at a slower pace. Until recently, scientists lacked a clear understanding of how to characterize exosomes.
As the field has evolved over time, consensus has emerged among researchers regarding unified terminology and best practices for working with exosomes.
The Wild West
As scientists converge to meticulously bring exosome-based treatments to fruition, unscrupulous clinics have sprouted up worldwide, posing a threat to patients seeking innovative therapies. Their inaugural foray into the public sphere focused squarely on combating Covid-19. Found approximately 60 unverified US clinics touting exosome-based treatments as a means of combating COVID-19, despite lacking credible scientific backing. Tapping into its popularity, another notable trend has emerged in the realms of skincare and hair care, captivating consumers in the US, UK, and Japan alike.
While exosomes are regulated as biological medicines in the United States by the FDA and in the European Union by the EMA, this classification requires prior authorization from these agencies. Despite the ban, clinics continued to advertise such treatments, leading to devastating consequences. Following a 2019 incident in Nebraska, individuals who received untested exosomes developed sepsis, a severe and potentially life-threatening condition caused by an overwhelming bacterial infection that affects the entire body.
“Clinics peddling unapproved exosomes mislead patients by making unfounded assertions about their products’ ability to prevent, treat, or cure various ailments and conditions,” the company stated.
Japan’s economic growth is stagnant, posing a significant challenge for policymakers. Exosomes are not governed by regulations as they fall outside the scope of established laws. With nearly 670 clinics established to date, the Chinese market has grown exponentially, dwarfing those of both the United States and European Union in terms of scale. The vast majority of providers have aggressively promoted their products and services focused on skincare, anti-aging, hair growth, and combating fatigue, according to the authors. Rarely, a few boasted about their potential to combat cancers.
The rogue clinics have tragically resulted in devastating consequences. The researchers reported that a prominent aesthetic clinic had delivered exosomes to at least four patients, including family members of employees with advanced-stage lung cancer, only to observe that their disease rapidly deteriorated following treatment.
Due to the clinic’s secretive nature, it is challenging to accurately assess the scope of harm caused.
The primary concern isn’t that exosomes pose a threat as standalone entities. The manner in which access credentials are acquired plays a crucial role in ensuring overall system security. In unregulated environments, the likelihood of contamination is high, with bacterial endotoxins potentially triggering harmful inflammatory reactions or viable microbes that can thrive and multiply.
From a genuinely primordial perspective, we’re unclear about their intentions – benevolent or perilous. “I would not recommend taking them; let’s adopt a cautious stance,” advises James Edgar, a renowned exosome researcher at the University of Cambridge.
Unscrupulous clinics inflict irreparable harm on unsuspecting patients. Will they successfully establish a thriving new habit once more?
While scientific progress may appear sluggish at times, its deliberate pace is crucial for ensuring the reliability and effectiveness of discoveries, even if they don’t garner widespread attention or flashy headlines. Researchers continue to push boundaries by harnessing the potential of exosomes in addressing various health concerns, despite the need for further insight into these enigmatic cellular vessels.
