FAQs: Exosomes

Exosomes are not cells or tissue. Exosomes are produced within stem cells and are liberated to the extracellular space as tiny membrane-bound packages of powerful nanoparticles representing a “cargo” of RNA, DNA, peptides, proteins and metabolites to be transported to target cells at close or distant tissues. Generally speaking, Exosomes carry healthy and lost information to be inserted  into target cells. This usually happens in response to injuries.

Exosomes do not multiply themselves but assist other cells in their proliferation by inserting missing cell information in them. The information is basically: “This is what a healthy cell does and this is how to get there”. This process happens in 2 stages. In the initial phase, the exosome inserts their “cargo” into the cell and basically quenches the immediate inflammatory response. In the second phase, the response starts after 6-8 weeks in which the information initially transferred to the cells by the exosomes is now used by the receptor cells to regulate and reprogram the cell function and aid in the repair process. This will last approximately 3 months and can influence the stem cell activity in the body.

Exosomes can be administered topically, locally, through IV injection or IV drip, intranasal, intrathecal or intradiscal. For example as part of joint rejuvenation therapy, the exosomes are administered directly into the affected joint area. The normal concentration is 1 billion exosomes per 1ml. One treatment may consist of up to 15 billion exosomes. The dosing is individual to every patient. In some cases, exosomes may be combined with focused ultrasound frequency therapy or regional hyperthermia which may help attract them to a certain area in the body.
 

Exosome therapy is usually performed in an outpatient basis. Most patients should expect to leave the clinic without any down time. The patient will not experience any discomfort. Less than 10% of patients have reported developing a mild fever, headache, nausea or vomiting. However, if the patient develops these side effects they will not usually last more than three days . Most (if any) symptoms will usually resolve within 24 hours. No long-term negative side effects have been reported

In order to gain an optimal response from exosome therapy, we recommend the following:

• Refraining from taking anti-inflammatory medication
• No overly strenuous activity for the first 24–48 hours
• Resume cardio workouts after 3–4 weeks
• After four weeks, resume any weightlifting and running activity if they are part of your prior routine

Exosomes trigger a so-called bi-phasic response. First, there is an immediate reaction that usually last about 24 hours until the initial proteins have been broken down. Then the messenger RNA, which has been inserted into the target cells becomes active and helps ‘reprogram’ the cell. This usually takes 6-8 weeks. So, the timeline is about 8-10 weeks. The continued effects may continue for months afterwards.

In the initial days following a therapy, patients generally report a reduction of their inflammatory symptoms. The following weeks can be accompanied with light flu-like symptoms and fluctuating energy. After 6-8 weeks, the cell function and repair processes have been reprogramed. This process can again result in episodes of  low energy or mild flu like symptoms and a flare up of symptoms of your individual medical condition. Typically, early benefits of therapy are observed in 3-4 months and continue for 9 -12 months.       

Both adult stem cells and exosomes have their place in a treatment protocol and depends on what the treating physician is trying to accomplish. When performed correctly, treatment with exosomes and/or stem cell therapy is safe. Therapy with exosomes may carry a lower risk of complications as exosomes do not require a surgical procedure for harvesting.

There is a general standard exosome solution that is produced from placental derived mesenchymal stem cells. These stem cells are GMP laboratory stem cells, which have been screened and certified. The end product contains many anti-inflammatory cytokines and immune modulatory proteins.
It is also possible to produce different kinds of exosomes. Some involve the use of a patient’s own tissue to provide specific markers in combination with laboratory produced exosomes. The legalities in each country also play a role in what is possible. The treating doctor can decide if individualization is necessary and what that best type of individualization may be.

Our Exosomes are sourced from laboratory grade, GMP certified mesenchymal stem cells. Placental mesenchymal stem cells produce exosomes with the correct expression for our use. We commonly acquire the basic product from Kimera Laboratories, with Dr. Duncan Ross as director. Their process allows us to harness the healing power of those stem cells without the risk of cell proliferation (tumoral) with benefit from higher production yields and at an affordable cost.

The starting material of exosomes (mesenchymal stem cells) are GMP laboratory grade, meaning they have been screened for disease, viruses and bacteria. Once the exosomes have been extracted from the stem cells, the stem cells are discarded. The finished exosomes solution is sterile, filtered, and tested according to the standard pharmaceutical regulations.

Exosomes suspended in saline must be kept frozen.

Cancer Exosomes can cause cancer to grow. These are not to be confused with exosomes derived from stem cells which we use in treatment. Stem cell derived exosomes can actually be indicated in the treatment of some cancers as they can insert the missing proteins into the cancer cells and stop their replication.

No, as exosomes are NOT embryonic stem cells. Again, exosomes are not cells or tissue and consequently do not multiply. Exosomes transfer valuable biological signals to the recipient’s tissues and facilitate the normalization of various pathological processes.

In some cases, a follow-up treatment may be advised. There is no sustainable data about standard dosing and the treatment is as individual as the response. Some patients may need a single application, while others need multiple doses or a small booster therapy. In some cases, therapy may start with a small initial dose which is increased over time.
 

Exosomes are a form of cellular therapy and a similar timeline can be applied when it comes to assessing the body’s response. Therefore, the same follow-up routine is scheduled, and the progress is measured after approximately 3 months to determine the customized follow-up treatment protocol and home care protocol.

This will have to be decided on a case-by-case basis. There may be an added cost that will be quoted in advance if exosome treatment is recommended.

Recent research has shown that stem cell-derived exosomes have an anti-inflammatory potential and induce high levels of anti- inflammatory cytokines and can therefore assist to regulate the inflammatory response. In addition, they can also inhibit abnormal macrophage activation. The macrophage is a large white blood cell that is an integral part of our immune system. Its job is to locate microscopic foreign bodies and ‘eat’ them. However, disproportional macrophage activation can induce undesirable inflammatory processes.

Chronic infections have a lot in common with autoimmune diseases, including dysregulated immune response incapable of protecting our body from pathogens (bacteria, viruses, molds etc.) while attacking our own body tissues and organs thus causing significant structural damage. One of the key mechanisms controlling the direction of immune responses is a balance between specific protective immune cells vs autoimmune responses. Exosomes from mesenchymal stem cells have shown to normalize that immune balance and bring the deviant immune response back to normal.

Research has shown that exosomes can penetrate the blood-brain barrier and stimulate neuronal differentiation, neuronal growth, and suppress inflammatory processes within the brain tissue.