Is Exosome Therapy FDA Approved?

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The Code of Federal Regulations of the United States Food and Drug Administration (FDA) stipulates that the uncertainty of the scientific evidence of the over-the-counter (OTC) drugs claiming to be for hair loss treatments warrant the need for these drugs to be scrutinized. Specifically, new drugs and substances that have been claimed to address hair loss still need to be clinically tested and evaluated to ensure their efficacy and safety.

So is exosome therapy FDA approved? Exosome therapy is a new technology that’s still undergoing clinical studies. Many healthcare providers are claiming that it’s just a practice of medicine and doesn’t need FDA approval for its use. However, it’s still technically a new drug that the FDA needs to regulate and hasn’t yet approved.

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Why Exosome Therapy Isn’t FDA Approved

The United States Food and Drug Administration (FDA) is the regulating body that ensures the safety of consumers by regulating the use of drugs, biological products, and medical devices, among others. A clinical investigator from the FDA takes time to weigh the benefits and risks of new drugs before approval, which they oversee through a structured framework they follow.

Currently, there are still no US FDA-approved exosome products in the market. While stem cell clinics that also offer exosome products falsely claim that there’s no need to seek FDA approval for these kinds of regenerative medicine products, a vial of exosome products is still a medical product that the US FDA must regulate to ensure the safety of the patients.

Potential risks of these treatments are still not fully uncovered, especially since clinical studies are still being conducted with these kinds of therapies. In fact, some clinics even claim that they’re operating exosome therapy under investigational new drug application (IND) in the FDA, and patients must be wary of these claims. To verify further, they should ask for documentation from the FDA.

How Exosome Therapy Works

An exosome is an extracellular vesicle that budded off from the plasma membrane (the semi-permeable covering of the human cell), which contains compounds responsible for intercellular communication. They are mesenchymal stem cell-derived products that can deliver specific compounds such as RNA  (responsible for protein synthesis) to target cells. They can be found in different bodily fluids such as blood and saliva.

Initial clinical studies regarding exosome treatment for hair loss have also shown that it’s capable of stimulating hair growth by encouraging the growth of hair follicles, shortening the time that the hair follicles stay at the telogen phase (resting phase) to the anagen phase (growing phase), and acting as antioxidants that protect the hair follicle cells from reactive oxygen species (destructive molecules derived from oxygen). 

Benefits Of Exosome Therapy

Aside from its promising effects against hair loss, exosome treatment also shows promise in bringing a lot of potential benefits to address a variety of diseases such as SARS-CoV-2 infection, cancer, peripheral nerves, bones, cartilages, and inflammatory diseases of the brain. It also has diagnostic applications against cancer cells and metastasis. It’s one of the newest trends in regenerative therapy available for people who would want to try biological products in addressing their abnormalities. 

1) Protection Against Microbial Infection

Exosomes are capable of modulating the immune response against microbial pathogens. It’s shown to be capable of strengthening the immune response through antigen presentation (the process in which molecules from the pathogens are exposed to be easily detected by immune cells).

It’s also capable of immunosuppression, which is vital so that the immune cells won’t go into overdrive that may also be damaging to the body. In fact, clinical studies are being done to investigate the possibility of the use of exosome therapy in improving the morbidity and mortality profiles in COVID-19 patients.

2) Role In Tumor Progression And Metastasis

It was established that promoting the production of new blood vessels and helping the spread of the tumor to metastasis sites are the role of exosomes in tumor progression and metastasis. As such, studies directed towards manipulating this fact are being done in order to potentially manage cancer through exosome use. Some applications of exosomes include:

  • The potential use of exosomes as biomarkers (biological products used in the diagnosis of a disease such that a disease is present when high levels of these biomarkers are detected);
  • The potential of exosomes as targets of the mechanisms of action of therapeutic agents (for example, blocking exosome production); and
  • The potential of exosomes as vehicles to deliver cancer antigens to produce immune responses against cancer. 

3) Therapy For Traumatic Brain Injury

Clinical studies have shown that exosome therapy is helpful in addressing traumatic brain injury morbidity and mortality through immune modulation that results in reducing the degradation and inflammation of neurons (brain cells) and promoting the growth of new neurons and blood vessels in the brain.

Moreover, clinical studies in a rat model also have shown that the use of 100 ug of exosome treatment is the optimal dose in returning the brain functioning in those who underwent moderate cortical contusion that induced the brain injury in rats.

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4) Therapy For Peripheral Nerve Injury

The exosomal cargo (the compounds found in exosomes), such as miRNA, are important in promoting the production of membrane and cytoskeletal proteins. These proteins are essential in promoting axonal (a part of brain cell) growth. This is a good way to shift the therapy from grafting or harvesting and sacrificing functional Schwann cells of the brain to culture the cells to less invasive regenerative therapies such as the use of exosome products.

5) Therapy For Cartilage And Bone Tissue Regeneration

The role of exosomes in addressing bone and joint diseases is promising, as they’re shown to promote the repair and regeneration of cartilage and bones. Exosomes are observed to induce the production of cartilage and bone cells while inhibiting the biological markers necessary for catabolism (breakdown) and inflammation.

Safety Of Exosome Therapy

At present, there are still no known contraindications (patients in which the therapy can’t be administered) of the procedure because it’s a ready-made product in which the donor stem cell products are already stored in vials. As long as they’re properly harvested, these products are said to be safe for use and not contain contaminants that may lead to communicable diseases or malignancies.

Moreover, at present, the only known side effect of exosome therapy is an injection site reaction in which pain, bruising, or swelling in the injection site may be felt after the treatment. It’s considered to only have minimal downtime, in which patients who underwent this therapy can proceed to their normal activities, provided that they won’t engage in strenuous activity within 24 to 72 hours after the treatment. Other things to be avoided within at least 24 hours after the therapy include alcohol intake, use of tobacco products, and eating salty and sugary foods.

Other Hair Restoration Treatments

There’s still a scarcity of clinical studies regarding the efficacy and safety of MSC-derived exosomes. While it’s still undergoing clinical studies, you may consider other hair restoration treatments with already established efficacy and safety profiles. However, caution still must be exercised when considering these treatments for hair loss as not all of them are FDA approved.

1) Hair Transplant Surgery

Hair transplant surgery entails a surgical procedure of grafting scalp hair or hair follicle strands in areas with visible baldness. Two techniques of hair transplant surgery are currently available, and it’s a matter of preference as to what you want to undergo.

  • Follicular Unit Transplantation (FUT) – Follicular unit transplantation entails taking a section of scalp skin and transferring it to the areas of concern.
  • Follicular Unit Extraction (FUE) – Follicular unit extraction entails making tiny holes in areas where the transplant will be done and transferring hair strands in these tiny holes.

Although it’s an invasive procedure, adverse events associated with hair transplant surgery are minimal and may go away on their own. These side effects include bleeding, infection, and an unnatural-looking scalp; the grafted skin didn’t match the area it was transferred to). To alleviate some of these symptoms, you may be prescribed by your healthcare provider some pain and anti-inflammatory medications, and antibiotics.

2) Stem Cell Therapy

In stem cell therapy, a cylindrical sample of scalp skin is removed from the patient. This scalp skin will then be processed and its stem cells separated from the tissue using centrifugation. Upon processing, the stem cell formulation will then be re-injected back to the patient’s scalp where baldness is apparent.

Injection site reactions are the possible side effects of this procedure, such as bleeding and swelling on the site of injection. Caution must still be exercised when undergoing stem cell therapy because, although a study has shown an improvement in hair density in patients that underwent stem cell therapy, stem cell is also yet to be approved by FDA for hair loss. The only approved use of stem cells as of the moment is for bone marrow transplantation.

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3) Platelet-Rich Plasma Therapy

Platelet-rich plasma (PRP) therapy entails taking a blood sample from the patient’s peripheral veins. This blood sample will then be processed via centrifugation, where platelets and their growth factors will be concentrated and the other blood components such as red blood cells are discarded. Upon processing, the PRP formulation will then be injected in areas with visible hair thinning.

Similar to stem cell therapy, injection site reactions are the common side effects of PRP therapy. The procedure isn’t also for everyone, in that people who use blood thinners such as aspirin and have other medical conditions such as psoriasis are discouraged from undergoing this procedure.

4) Laser Combs

Clinical studies support the efficacy and safety of laser combs, also known as low-level laser therapy (LLLT), in addressing hair loss. The company that manufactures laser combs claims that its use has received clearance from the US FDA. In 2009, it’s available for use for males 30 to 60 years old, while in 2014, its use was further expanded to females that experience androgenetic alopecia. The only known side effects of this treatment are itching and tingling of the scalp.

5) Medications

Medications such as the topically-applied minoxidil and finasteride are the most widely-used treatments for hair loss as of the moment. Their use against pattern hair loss or androgenetic alopecia is approved by the US FDA. Side effects associated with these drugs when used against hair loss include swelling and itching in the site of application.

PEP Factor: A Safe Solution To Hair Loss

Exosomes are multivesicular bodies derived from sources of mesenchymal stem cells such as umbilical cord blood and amniotic fluid. The potential therapeutic applications of exosomes are diverse, from diagnosing infectious diseases to possibly addressing chronic diseases such as chronic pain, autoimmune disorders, and even cancer. However, much like unproven stem cell treatments, these biological products are yet to get approval from the FDA due to the need to make sure that these products are safe for use.

As such, alternatives that can yield the same results to hair loss as what exosome treatment is promising to deliver, such as FACE Med Store’s PEP Factor. FACE Med Store’s PEP Factor can also be complemented with other products or procedures such as microneedling to help improve the appearance of thinning hair.

With its natural components, especially the active ingredients such as basic Fibroblast Growth Factor (bFGF) and copper peptide which are known to have cell growth and antioxidant properties, PEP Factor is surely a high-quality and safe solution to hair loss.

Shop Safe And High-Quality Products At FACE Med Store

Therapeutic exosomes are regenerative medicine products that have the potential to address a wide range of conditions in humans due to their ability to stimulate the natural healing processes of the human body. However, the potential risks of the procedure are not yet fully studied in detail so it’s still an unapproved product by the FDA.

At FACE Med Store, we only offer safe and high-quality products to patients. All our products are compliant with the regulations set by the FDA. We have excellent customer service that goes with our top-of-the-line products for both businesses and regular clients. Contact us now at (800)770-9083 or browse through our site to learn more.

All content in this blog is for informational purposes only. It is not medical or legal advice. Please consult with lawyer or a medical professional.