What are Exosomes?

Imagine your body is like a busy city with tiny mail trucks called exosomes zipping around. These trucks carry special packages (proteins, messages, tools) that help different parts of the city work together. They can tell cells to grow and fix themselves, build new blood vessels, or even calm down if there's an argument (inflammation). Because they're tiny and flexible, they can travel everywhere and deliver their packages safely. It's like having a mini repair crew working inside your body, keeping everything running smoothly! That's why scientists are excited about using exosomes to help heal injuries and even grow new tissues, like fixing a broken sidewalk or planting a new park in the city (1)!

Exosomes are a type of extracellular vesicles, produced within multivesicular bodies, that are then released into the extracellular space through a merging of the multivesicular body with the plasma membrane. These vesicles are secreted by almost all cell types to aid in a vast array of cellular functions, including intercellular communication, cell differentiation and proliferation, angiogenesis, stress response, and immune signaling. This ability to contribute to several distinct processes is due to the complexity of exosomes, as they carry a multitude of signaling moieties, including proteins, lipids, cell surface receptors, enzymes, cytokines, transcription factors, and nucleic acids. The favorable biological properties of exosomes including biocompatibility, stability, low toxicity, and proficient exchange of molecular cargos make exosomes prime candidates for tissue engineering and regenerative medicine (1).

Inflammation

Imagine your body is a busy city with lots of people working together. But sometimes, fights break out (inflammation), and it can damage buildings (cells) and make things run poorly. Scientists have discovered tiny messengers called "exosomes" that can act like peacekeepers! They come from special "MSC stem cells" and carry messages that tell the body to calm down and stop fighting. This helps with problems like:

Heart attacks and strokes: Exosomes can help mend the damage caused by inflammation in your heart and brain.
Type 2 diabetes: They can help regulate blood sugar levels by calming down inflammation in your body.
Alzheimer's disease: Exosomes can protect brain cells from damage caused by inflammation.
Even cancer: They can help stop the inflammation that can make cancer cells grow faster.

It's like having tiny firefighters putting out the flames of inflammation before they cause too much damage! That's why scientists are so excited about using exosomes to help treat many different diseases. They're like little peacekeepers keeping your body healthy and strong (2).

Many scientists now consider inflammation as the root cause of most chronic diseases such as heart attacks, strokes, type 2 diabetes, Alzheimer’s disease, and even cancer. Therefore, regulation of inflammation is an important therapeutic target to treat inflammatory diseases. It has been demonstrated that MSCs have property of intrinsic immunosuppressive capabilities to alleviate inflammation and immune responses (2).

Cell-Free Therapy

Imagine tiny mail trucks called exosomes zipping around your body instead of using live stem cells! These trucks carry special instructions that help fix problems in different places, like:

Tired hearts: The messages tell heart cells to work better, like giving them a pep talk.
Hurt kidneys: They deliver instructions to help rebuild kidney cells, like sending blueprints for repairs.
Lumpy lungs: The messages tell lung cells to calm down and stop getting inflamed, like soothing a cough.
Dry skin: They instruct skin cells to make more protective stuff, like building stronger walls.
Weak muscles: The messages tell muscle cells to grow stronger, like giving them a mini workout.
Confused brains: They deliver instructions to brain cells to work together better, like fixing scrambled signals.

The best part? These tiny trucks are safe and can even help with problems caused by inflammation, like redness and swelling. It's like having miniature firefighters putting out fires inside your body! That's why scientists are excited about using exosomes to help with many different problems, keeping you healthy and strong from the inside out (3).

Exosomes are a cell-free therapy, which would minimize safety concerns about injecting live cells. The therapeutic efficacy of MSC-derived exosomes has been shown in heart, kidney, lung, skin, muscle, and brain diseases. In many cases, the mode of action of such exosomes in treating diseases is derived from their anti-inflammatory activity. MSC-derived exosomes contain anti-inflammatory components, which are delivered to the recipient cells, reducing inflammation. Taking advantage of these characteristics, MSC-derived exosomes can be applied to various inflammatory diseases and autoimmune diseases (3).

What Can Exosomes Do?

Picture tiny messengers called "exosomes" zipping around your body like mini mail trucks! These trucks carry special instructions to help fix different problems:

For slow-healing wounds, they tell cells to grow faster and build new blood vessels, like giving a boost to construction workers.
For damaged nerves, they deliver messages to help them regrow and reconnect, like fixing broken wires.
For weak hearts, they send instructions to strengthen heart muscles, like giving tiny pep talks to athletes.

Scientists are super excited about these "mail trucks" because they're safe, effective, and could even replace treatments like using stem cells in the future!

It's like having a tiny repair crew working inside you, fixing things up and keeping you healthy (1)!

In recent years, it has been established that exosomes have modulatory potential and play a critical role in diverse biological processes. Exosomes show tremendous therapeutic potential for disorders including chronic wound healing, neurological damages, and cardiovascular dysfunction. Exosomes have also gained widespread attention in the field of biomarker research and are now even being seen as an alternative strategy to stem cell-based regenerative therapies (1).

*Research on specific ailments can be found under the "Research" dropdown

Stem Cells Vs Exosomes

Imagine tiny mail trucks called "exosomes" delivering instructions from special stem cells to fix different problems in your body:

For slow-healing wounds, they tell cells to grow faster and build new blood vessels, like speeding up construction workers.
For damaged nerves, they carry messages to help them reconnect, like fixing broken wires in the brain.
For weak hearts, they send instructions to strengthen heart muscles, like giving tiny pep talks to athletes.
For achy joints, they tell cartilage builders to get busy, like sending extra workers to fix a bumpy playground.
Even for other problems like lung issues, kidney trouble, and even cancer, exosomes might be able to help!

Scientists are excited because these "mail trucks" are safer and easier to use than the stem cells themselves. It's like having a mini repair crew working inside you, delivering the right instructions to fix different parts of your body! So next time you hear about stem cell treatments, remember the tiny "exosomes" that might be doing most of the work (1).

Stem cell therapies have increasingly gained momentum in treatment of disease; much of the research that has been done in recent years has focused on the potential significance of applying MSCs. MSCs are non-hematopoietic, multipotent, adult stem cells which can be isolated from many biological sources including bone marrow, umbilical cord, adipose tissue, brain, spleen, kidney, and liver. MSCs can differentiate into adipocytes, chondrocytes and osteocytes, as well as endodermal (hepatocytes) and ectodermal lineages (neurocytes). In addition to their mechanical differentiation properties, MSCs also secrete exosomes and biomolecules including cytokines, chemokines, and growth factors. Though initial reports indicated that MSCs may play a critical role in tissue repair, investigations have shown poor survival and low grafting potential of MSCs in damaged tissue areas, limiting MSC effectiveness in tissue repair. Further studies have demonstrated that beneficial effects of MSCs applications in repair are attributable to paracrine signaling, which includes secreted vesicles such as exosomes. Interestingly, several studies indicate that exosomes secreted by MSCs can replace the MSC-based stem cell therapies in various injury and disease models. For example, MSC-derived exosomes (MSC-Exos) have been shown to induce repair in mouse models of wound healing and myocardial infarction. In particular, investigations have revealed that exosomes secreted by placental umbilical cord MSCs play a significant role in wound healing and tissue regeneration. Similarly, in the past few decades, studies have demonstrated that MSC-Exos can have advantageous effects in various contexts including neurological, respiratory, cartilage, kidney, cardiac, and liver diseases, bone repair, and cancer (1).

The information on this website includes quotes and concepts derived from scientific research papers. While these quotes are accurate representations of the original findings, they have been rephrased and simplified by Bard, a large language model, to make them more understandable for a general audience.

Bold text has been rephrased by Bard

Direct quotes are in regular text

FDA / REGULATORY INFORMATION

FDA REGULATORY INFORMATION

In 2014, the FDA announced its intention to adopt a selective regulatory approach towards the exosome industry, aiming to foster growth in the field of exosome therapies. The agency stated that regulations would primarily target firms engaging in illegal practices, such as the failure to ensure product sterility, while facilitating expedited FDA-approved trials for compliant companies. However, despite these efforts, many companies did not pursue FDA approval, leading to the program’s failure. Consequently, by the end of 2018, the FDA reversed its position and began shutting down non-compliant companies.
In contrast, our manufacturing partner took a meticulous and extensive approach, dedicating over 11 years to refining and testing our exosome product. As a result, by the end of 2021, our manufacturer received an FDA master file, establishing our product as the first and only legally recognized regenerative medicine drug derived from human umbilical cord exosomes in the United States.

EXOMED TAKES PRIDE DISTRIBUTING THE SOLE COMPANY REGISTERED AS A BIOLOGICAL DRUG IN THE UNITED STATES, UTILIZING HUMAN UMBILICAL CORD-DERIVED EXOSOMES.

This distinction ensures that our exosomes adhere to the highest standards of safety and efficacy, subjecting them to rigorous testing and regulatory oversight by the FDA.

Our exosomes, derived from human umbilical cords, are among the safest and most potent available in the market. As a 351(a) biologic product, they can be sold for research and investigatory use, having undergone thorough testing and receiving third-party virology reports to guarantee their safety and effectiveness.

FDA MASTER FILE AVAILABLE ON REQUEST.