What Is Exosome Therapy?

Exosome Therapy is the new frontier of regenerative medicine for the treatment of Lyme Disease, Mold Toxicity, and other chronic illnesses resulting in severe neurological inflammation or other degeneration.

Considered to be one of the purest forms of regenerative medicine and cell therapy, exosomes are extracellular tiny lipid vesicles (30-150 nm) that are involved in direct cell-to-cell communication and secreted from a cell to help maintain viable cellular terrain.

The use of exosome therapy is relatively new but has shown promise with the treatment of chronic illness by unlocking the body's natural healing mechanism within a person's own cells, resulting in a reduction of chronic inflammation and supporting the regeneration of cells and tissues.

Exosome therapy involves administration into an affected joint or as an IV treatment.

Direct Biologics’ ExoFlo™ exosomes are isolated from human bone marrow mesenchymal stem/ stromal cells (MSCs). They are purified using proprietary cGMP processing and are sterile filtered and tested per USP<71> sterility testing. The unique benefit to Direct Biologics exosomes is they provide a wide array of regulatory proteins to stimulate and modulate many processes within the normal healing cascade.

Exosome Therapy For Treatment of Lyme Disease
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Exosomes are being heralded as the next frontier of cell therapy. While not being cells at all, they play a vital role in the communication and rejuvenation of all the cells in our body. Science has shown that the cell-to-cell communication is important in maintaining a healthy cellular terrain.

Age, chronic disease, environmental factors and genetic disorders can interfere with how our stem cells communicate with other cells, thus disrupting the healing process. Exosomes play a key role in the regulation of these communication processes.

What are exosomes?

Exosomes are small structures called micro-vesicles. About 1/1,000th the size of a cell, exosomes are important for cell-to-cell communication and regeneration.

The roles of exosomes, growth factors and cellular activity in regenerative medicine

Healing, repairing, reconstructing—this is the very nature of cells. Increased scientific understanding has revealed a revolutionary healing modality. This is true stem cell therapy—providing targeted treatment to the patient’s own cells by modulating the cellular activity.

This happens by introducing the patient’s cells to a healthy and younger combination of naturally occurring growth factor proteins and exosomes.

What are Exosome growth factors?

A growth factor is a naturally occurring protein capable of stimulating cellular growth, proliferation, healing, and cellular differentiation. Usually, it is a protein or a steroid hormone. Growth factors are important for regulating a variety of cellular processes.

How are exosomes made?

Inside the cell, a cell membrane forms inward, forming a special type of lipid vesicle called an endosome. Then the proteins, microRNA and messenger RNA, invaginate the endosome’s membrane, forming the exosomes.

Endosomes then fuse with the surface of the cell, releasing the exosomes outside of the cell. Due to the observation of this process, historically, exosomes were believed to be a waste byproduct of cells. But when researched further, and it was discovered that, in fact, these are the mediating mechanisms involved in direct cell-to-cell communication.

Producing anti-inflammatory effects

These produce an anti-inflammatory response due to the communication from the many proteins that downregulate inflammatory proteins.

Other proteins will then recruit stem cells to the area that will help upregulate these cells to proliferate and promote organized healing through the regulated process. Then, once the task is complete, there are additional proteins that tell the cells when the healing has been completed.

These exosomes, with the presence of over 1,000-plus growth factors, are being regarded as one of the purest forms of stem cell therapy. In their natural state, they offer proteins and no DNA or potentially harmful byproducts that can be found in other therapies.

What are the potential benefits of exosome therapy?

Those with degenerative or autoimmune conditions could potentially benefit from exosome therapy as well as those wanting:

  • To reduce pain and inflammation
  • To speed up recovery from an injury
  • To improve the body’s overall healing ability

An Introduction to Exosome Therapy And Its Costs

Are you curious about how exosomes relate to conversations about stem cells? Maybe you’ve heard of exosome therapy and its regenerative capabilities.

But what exactly is exosome therapy and what are the benefits to cell biology?

Keep reading for an introduction to exosomes so you can better understand how this type of therapy is advancing the field.

Why Are Exosomes Important?

Exosomes have been described as tiny bubbles that are released from cells, especially from stem cells. They’re also called extracellular vesicles. These “bubbles” are lipid spheres that carry genetic information and protein to be delivered to other cells.

How Do Exosomes Work and How Are Exosomes Different from Stem Cells?

The exosomes that are used in regenerative therapy come from stem cells. Exosomes contain a lot of the same important functions of stem cells, but they are different.

The use of stem cells became popular in the early 2000s. Adult stem cells have been used in therapy and the goal was for these cells to migrate to the area of disease or damage in the body. The most common type of adult stem cell is the mesenchymal stem cell (“MSC”).

There are many benefits and risks to this type of therapy. The safety has also not been proven, according to the FDA.

Over time, it became clear that adult stem cells rarely facilitate new tissue growth. However, they can be highly beneficial for their cell signaling. The cells that will heal the body are thought to already be there, but they need the proper signals. Science is now showing us that exosomes are an effective way for stem cells to deliver these signals.

Exosomes are able to tell cells how and when to react. This is because of their shape and content. They carry messenger RNA, genetic information, and proteins.

Exosomes that are from stem cells, such as MSCs, appear to exert powerful effects. For example, they may be anti-inflammatory or prevent scar tissue formation or facilitate a healthy immune response. Messenger RNA helps other cells by inserting missing cell information.

What is Exosome Therapy?

Exosomes are being looked at for many types of therapy. It’s thought that patients who suffer from degenerative diseases can greatly benefit from exosome therapy.

This is because exosomes that are derived from stem cells have anti-inflammatory possibilities. They can induce high levels of anti-inflammatory cytokines.

So patients with autoimmune disease can benefit. Exosome therapy may also benefit patients with inflammation and degenerative joint disease.

There are many approaches that are being researched for creating drug-loaded exosomes. One approach includes using a drug in exosomes that have been refined from donor cells. Another approach is looking at loading cells with a drug, which is then contained in exosomes.

They are specifically looking to use exosome treatments for rare diseases.

Exosome therapy holds a huge potential and is also researched in cancer cell-derived exosomes. Researchers are looking at exosome drugs that could be harvested from stem cells and then housed in a bioreactor. Once they’re purified, they could become a drug product that’s given by injection or infusion.

What Are the Benefits of Exosome Therapy and How is it Used Today?

As time goes on and research develops, there are reports of the benefits to exosome therapy. Some patients report feeling reduced inflammation from their chronic disease. This leads researchers to hypothesize that exosomes may have a role in helping to repair or regulate disease progression.

Exosome therapy is also being explored in Lyme Disease patients, as using exosomes might break the inflammatory cycle. It may also provide the body with cellular information that could help in the healing process.

Exosome therapy might be less risky than live stem cell transplants. This is because exosomes can’t replicate and they can’t transform into harmful cell types.

Other diseases like Parkinson’s Disease might also benefit from exosome therapy. This disease is due to a loss of specialized cells over time. Exosomes have regenerative genetic material and deliver protein and lipid cellular building blocks. These properties can help restore cells to health.

What are the Risks?

It’s possible that a person could reject the exosomes. This is seen as unlikely since exosomes aren’t cells or tissues so the body would probably not see them as a foreign substance.

Clinical trials are looking at the risks and seeing that it’s possible for exosomes to die-off, so many are giving a small test dose before a larger one.

Most importantly, no exosome products have been approved by the FDA. Meaning, all exosome therapies are experimental. 

In some cases, they may be incorporated as a part of an approved stem cell treatment.

What Is The Cost of Exosome Therapy?

As explained above, there are no approved exosome therapies, so all exosome treatments are experimental and unapproved by the U.S. FDA.

Nonetheless, there are companies within the U.S. (and worldwide) that offer exosome treatments.

These exosome therapies are either delivered by intravenous infusion for chronic or systemic (full-body) conditions. Or, they are administered by local injection for site-specific conditions (usually orthopedic).

Understanding Exosome Therapy and Its Uses Today

The above introduction to exosome therapy will help you understand the basics of exosomes and how they’re being used today.

It’s important to understand how exosomes could benefit people with degenerative diseases and what types of therapies are being developed. The anti-inflammatory properties of exosomes could potentially make them a useful treatment for many types of diseases. Research continues to expand, especially as exosomes relate to stem cells.

Exosomes Lipid Treatment

*Sponaugle Wellness Institute cannot guarantee individual patient outcomes.
Treatment results will vary from patient to patient.