Exosome Therapy

Exosomes are useful as drug carriers because they are, by nature, capable of fusing with cells and do not express danger signals that can cause immune rejection. They have been heavily researched in the context of various diseases, including tumors and inflammation. Exosomes also have great therapeutic potential for wound healing and regeneration and have shown great potential in tissue repair in the skin, kidneys, bones, and cartilage. Various types of exosomes for disease therapy have been established. In addition, exosomes are actively studied as a factor in organ-on-a-chip technology, where they can demonstrate drug safety and toxicity using patient-derived cell culture. New applications and purification methods for exosomes are under development and are expected to help replace existing therapeutic sources. The establishment of industrialized techniques to purify allogeneic exosomes will rapidly promote the development of exosome therapy, but this is now under basic research. The acceptance and practical use of exosomes in clinical care and regenerative medicine are still in theoretical stages. Only a limited number of clinical trials are currently underway.

Benefits of Exosome Hair Treatment

A revolutionary new hair treatment that goes by the name of exosome hair therapy has emerged in the last year. It is very popular and gaining traction quicker than we ever expected. High-profile news sources are starting to write about it, and hair clinics are rushing to endorse it. It is forecasted to be a game changer in hair regeneration treatments. Exosomes derived from adult stem cells may potentially be used clinically to regrow hair by stimulating the multiplication of hair follicle cells. At the same time, exosomes can also encourage the proliferation of tissues that line the hair follicle. This creates a protective layer that rejuvenates the skin and promotes hair growth. Exosome therapy fortifies hair follicles, aids the regeneration of new ones, and improves overall hair growth. Exosomes are known to contain growth factors and signaling molecules that aid in cellular repair. As a result, when they are topically applied to the scalp, regeneration and repair processes are kickstarted. Clinical results from numerous studies have discovered that exosome hair therapy aids in combating hair loss while also encouraging hair growth in a minimally invasive manner. As a result of their standard dilution schedules, patients typically have minimal downtime and minimal adverse effects. Overall, exosome hair treatments are still in their initial investigative stages, but they show a lot of potential and could be further developed into efficient hair restoration treatments.

Rationale for Using Exosome Therapy

Cells in the human body secrete exosomes, which are used to transport proteins, lipids, and nucleic acids with intercellular function. This suggests that exosomes, which facilitate cell-to-cell communication, could be used medicinally. Exosomes’ roles in regeneration and healing are so prominent that some researchers believe that exosomes are the active medium in most forms of stem cell-based regenerative medicine more often than cells themselves. Exosome therapy, therefore, could potentially revolutionize the treatment of healing-resistant injuries, cancer, and chronic pathologies. Exosomes can home in on a tissue of interest and a specific cell type in a tissue. Using exosomes, healthy cells in the vicinity of the injured, unhealthy cells can transfer the healing proteins, lipids, and nucleic acids found in exosomes to the site of injury. Exosomes are also able to transport signaling molecules with unique “eat me” or “avoid me” signals to receptive or non-receptive cells, respectively. Though they originate within cells, the exosomes themselves do not become infected by cell originators’ viruses or develop cancer. One downside of exosome therapy may be that because exosomes are relatively small, they can be cleared from the circulatory system in as little as 24 hours. However, this may be less likely if packaged in a lipid complex. While they overlap with stem cells in some ways, exosomes offer better treatment options than cells in some cases. Daily injections of proteins and enzymes can shrink liver scars in mice by 40-50%, as they do in people, with the treatment. In a patient with the bone marrow disease crisis, a single dose saved him from being put on a liver transplant waiting list. These biologicals are otherwise inert without exosomes to deliver them to target cells. For systemic illnesses like traumas or mental health conditions, exosome delivery of biological treatments could even be preferable to today’s common local treatment with surgery or injection of live cells. They argue that surgery, for example, is not appropriate for treating widespread fibrosis in chronic diseases, since laceration causes additional injury, and anesthesia and pain medications are contraindicated. Nor is stem cell transplant the solution for every patient, due to the risks of immune rejection and cancer promotion. They estimate that the niche application of exosomes as a delivery system for biotherapeutics could become an $8 billion market in 5 years, growing as large as $80 billion in 10 years, a 60% compounded annual growth rate. Logically, they assert that to be effective, exosome source material should be very similar or identical to the products of cultured mesenchymal stem cells released, since exosomes are basically a way stem cells exert their protective anti-inflammatory effects in health and disease.

Exclusions for Exosome Treatment

It is not appropriate to provide exosome therapy to individuals with the following: 

· Active infections in the application site area – Not only will the impact of exosome therapy at the infection site not be able to manifest in the desired manner, but also the therapy of this kind can result in a further spread of the infection or other adverse effects. 

· Anyone with bleeding disorders – Exosome therapy can result in hemorrhage or hematoma formation at the injection site. 

· Pregnant and breastfeeding women. Exosomes, just like other types of extracellular vesicles, do interact with tissues or even cross the blood-brain barrier, so we cannot exclude the presence of any harmful substances or exosome components for the baby. 

Additionally, there are concerns about the use of exosomes, such as the chemicals they contain, their ability to affect cell functions, and a lack of research on their protein and RNA components, which might potentially interfere with breastfeeding. In general, oncological diseases do not constitute a formal contraindication for exosome-based therapy. However, patients who are in the initial course of their chemotherapy or radiotherapy are excluded. These cancer treatments are associated with increased chemotherapy agent levels in the body and, consequently, an acceleration in the excretion of medicines. It is also important to exclude people with autoimmune diseases from observation. Such patients are critically evaluated on an individual basis; however, the use of exosomes is not recommended in such cases. Any decision should be made predominantly by medical professionals who are familiar with the treatment of a given illness.

Presence of Active Infection in the Application Area

Exosomes are safe and beneficial for patients who are appropriately selected by a healthcare provider to ensure that no active infection is present in the application area. If an active infection is present, the exosome therapy could decrease the detection of such an infection due to its anti-inflammatory properties, but the infection will not be resolved until it is adequately addressed by a healthcare professional. Implementing exosome therapy under these conditions could result in an impaired healing process and increased risk of complications. A healthcare provider must evaluate the application area for any active infection and proceed with the exosome therapy only after the healthcare provider determines that treatment is permissible post-evaluation. The patient could be compromised and betrayed if not admitted to treatment in the case of underlying or acute infectious diseases. Sometimes the symptoms will appear to have almost resolved, only to reappear once the treatment has begun. One possible side effect of increased immune surveillance by exosomes is increased malaise experienced by the patient, and this level of malaise is correlated with increased immune activity that may occur as exosome therapy plays out over the first 7 to 10 days of therapy. Hence, this is not a contraindication for trying exosome therapy and may be a sign that it is triggering an immune surveillance response that is necessary for successful cell therapy. Only a healthcare provider can assess this condition, and these silent sentinel cells trained to search out infectious agents to assist your body in clearing these infections may move to the application area for several weeks as part of their desired beneficial pro-inflammatory role. It is the job of these silent sentinel cells, doing their job as designed, to make you feel unwell as cold and flu-like symptoms emerge in the days to weeks following treatment if an infection is present. This should be monitored and is not a contraindication or reason not to undergo treatment. It is an early indication that your treatment with mesenchymal exosomes is working normally with expected results against imperceptible deep underlying co-occurring disease. Only healthcare professionals can diagnose and treat patients concerning their individual infectious disease exposures or overcrowding afflictions. We hope the information provided helps support an appropriate informed consent that you can prepare in conjunction with your chosen healthcare professional, providing essential professional medical and infectious disease advice on this subject.

Bleeding Disorder

In deciding who might not be a good candidate for exosomes, exclusion criteria are included in order to minimize risk during and after the treatment process. One of the exclusion criteria is if the patient has a significant bleeding history, inherited or otherwise. Regardless of the etiology of the bleeding disorder, pre-treatment screening for commercial exosome therapy is recommended. The preferred effect from the presence of macrophages after the introduction of exogenous exosomes into the body will be to absorb the exosomes and take up their post-translational cargo to re-educate the remaining body macrophages. Careful and honest discussion of the risks of excessive bleeding and/or impaired healing in the presence of a known or still-to-be-diagnosed bleeding disorder will help prevent avoidable adverse events. Adequate preoperative evaluation of healthy and bleeding-disorder patients will likely avert unnecessary complications after both minor and major surgeries.

The caregiver should thoroughly review the personal and family histories, clinical options, and potential outcomes of treatment with the patient. These patients are generally in the most need of assistance to ensure their safety during the consent process. It is our hope that by providing a more complete picture of exosomes and blood coagulation, we will aid with full risk and benefit consideration when determining whether to seek exosome therapy for any condition. The healthcare provider who is considering exosome therapy for his or her patient should assess the need for potential coagulopathy and non-hemostatic effects before ordering exosomes, as well as counsel the patient on the weakness of the available clinical data for exosome production and re-education of the alveolar macrophages.

Pregnancy

Pregnant women are generally advised to postpone or avoid exosome therapy. A majority of healthcare providers are recommending against exosome therapy for pregnant women, and only a few are neutral on this issue. This consensus is based on the uncertainty and unknown risks of new therapies on the developing fetus should pregnant women receive exosome therapy. Exosomes have been shown to carry eukaryotic RNA and small noncoding RNA, in addition to prions and viruses that have unknown effects on pregnancy or fetal development. Thus, we recommend that pregnant women avoid receiving exosome therapy. The benefits and risks of exosome therapy should be discussed thoroughly between the healthcare provider and the potential patient, and the potential risks and benefits should be weighed heavily.

A complete pregnancy test should be performed before starting exosome therapy. Healthcare providers should inform patients to uphold at least three months of abstinence after ending all exosome therapy before attempting conception due to the potential for injury upon exposure of the conceptus to the drug. We suggest that women be advised to avoid becoming pregnant while they are receiving exosome therapy because of poorly understood risks to their pregnancy. Women who are partners of men receiving exosome therapy should be advised that the exosome treatment may be present in their partners’ seminal plasma. There are no data to inform avoidance of kissing or other close contact in people receiving exosome therapy. If pregnancy is confirmed in a partner of a man being treated with exosomes, healthcare providers should report the pregnant woman’s exposure to exosomes to the appropriate pharmaceutical company. This policy is not meant to be exclusionary and to exclude the pregnant patient, but to prioritize maternal and fetal safety, which is in line with regulatory guidelines. Explanation of the risks and other possible interventions may help the patient and her healthcare provider make an informed decision in the hope of a healthy outcome for her pregnancy.

Breastfeeding

Maternal decisions regarding care and treatment are often influenced by the need to consider the well-being of their breastfeeding children. A potential concern with respect to the use of exosome therapy in breastfeeding mothers is the transfer of possible exosome-based substances through breast milk and the potential unwanted effects on the infant. This is a relatively unexplored area of medicine, and caution is encouraged. Unregulated mast cell stabilizers and other drugs may pose a risk to the neonate, leading to the recommendation of suspending breastfeeding during treatment with such materials. A potential course for clinical decision-making might include the assessment of the benefits of continuing breastfeeding versus those of suspending treatment, given that the transmission of exosome-based substances through a mother’s milk may offer unique health benefits to the infant. In general, the pattern of healthcare providers is first to recommend the suspension of breastfeeding when faced with the unknown. This basic tenet of clinical medicine has not changed: it is always best to evaluate each maternal situation according to maternal needs, the health of the infant, age, developmental and nutritional alternatives, the health of parents, and alternative domestic arrangements. Mothers can usually evaluate unbiased information but should also consider any misdirected advice in the community setting.

Advising the breastfeeding mother in relation to the safety of exosome therapy presents the same dilemma. The decision-making between clinician and mother must always be formulated within the rationale mentioned above. Thorough recruitment discussions and informed consent, including education and understanding of the unborn child, breastfeeding network and wishes, reporting of potential complications, trial alternatives, and outcomes, are essential. With the practice of exosome therapy mainly being bound within the limits of reasonable entity type, both men and women are now aware and cautious of postponing pregnancy until they, or both partners, have completed. It is essential to recognize that while it is crucial for the health of children, breastfeeding interventions must also fully endorse maternal autonomy while meeting their personal goals. Mothers need to have full faith in the clinical decision-making process and minimize the occurrence of situations in which the maternal-child pair at risk evolves. Efforts should be made to ask these questions during the recruitment phase and further investigate the safety of exosome treatment in lactating mothers. By making informed choices, the reproductive healthcare providers of infant breastfeeding can ensure that the participants in interventions are buffered against any alternative or detrimental effects. During these delicate situations, all female faith becomes the human faith, the shutting-down faith, and the emergence to address a workable solution only tailored to their needs.

Pricing Information for Exosome Treatment

While costs can vary widely for exosome treatment, they can range from a few hundred dollars to close to or even over a thousand dollars depending on factors like the type of treatment, the provider, and the region. For surgical procedures with PRP and amnion injections, you can expect to pay for the initial appointment and imaging that may be necessary as part of your healthcare consultation. From there, regenerative medicine injections range between $300 and $800 per session. Follow-up appointments can range from $75 to $400. The complexity of the particular case will most likely determine if the treatment plan requires one injection or multiple treatments. For individuals seeking exosome infusions or exosome injections, they may be responsible for paying for the exosome treatment, the follow-up appointment to review imaging that may be necessary, and any additional follow-up appointments they may choose to schedule throughout their healing process. Currently, no insurance coverage exists for exosome injections for individuals with osteoarthritis, though payment plans may be available. To promote parity and transparency in pricing, some regenerative authorities include pricing to ensure potential patients understand the costs and successfully plan for exosome treatment. Patients are encouraged to review the published pricing or discuss pricing when they have a consultation with a regenerative healthcare provider. If a patient has any financial concerns about exosome treatments, the best course of action is to discuss the concerns with the provider. A fair amount of regenerative healthcare providers are willing to discuss concerns with patients, and they may offer options to accommodate patients with budgetary restrictions.