Exosome Therapy: Are there any clinical research studies on the use of exsomes for hair loss?

- Although there have been many anecdodal reports on the clinical efficacy of exosomes on hair loss, there is only one published case report to date on the use of exosomes to treat male pattern alopecia. - There are currently several investigator initaited studies underway on the safetly and efficacy of exosome treatment for hair loss.

Exosome Therapy: What are exosomes?

- Exosomes are micro-vesicles (30-150nm) that are involved in cell communication. This is a new frontier in regenerative medicine. These exosomes have been recently discovered to be involved in direct cell signaling. - The ExoFlo exosomes are isolated from donated human mesenchymal stem cells (MSCs) and purified using proprietary processing. The unique benefit to these exosomes is that they are stem cell-derived and bring a wide array of growth factors to stimulate and modulate many processes within the healing cascade. - Exosomes are not cells but are micro-vesicles, which are about 1/1,000th the size of a cell and contain no nucleus or DNA. They can be regarded as the purest form of cellular therapy available, because their function is to direct tissue and wound healing by activating the patient’s own regenerative cell response. - This is one of the latest generations of naturally bioactive stem cell-based products for patient treatment. - Stem cells and stem cell therapy work by paracrine signaling (local cell-to-cell communication to induce changes in nearby cells) to create the appropriate healing environment to restore tissue. - The exosomes in ExoFlo are those paracrine signals isolated from stem cells that can be delivered without the need for delivering stem cells. As the technology and discovery of new methods of treating patients has evolved, the science shows that the optimal way to provide true “stem cell therapy” is to directly provide the signals as its own therapy and avoid potential issues with delivering and keeping transplanted cells alive. - Stem cells by nature work to heal, repair, and restore the body. But, in some cases where there is a chronic abnormality, these cells fall into an inflammatory state, work in an unregulated capacity and inhibit healing. - The 1000+ growth factor proteins found to naturally occur in healthy tissue and in ExoFlo have shown to help modulate the inflammatory healing process. This is accomplished by activating and recruiting the patients’ own cells to the area, revascularizing the area and reducing the inflammatory response to allow natural healing. - Useful growth factors/signalers: MIP-1: A recruiter of mononuclear cells | VEGF: A stimulator to encourage blood vessel formation | SCF: An encourager of stem cell and melanocyte growth | FGF: A growth factor that signals cells to encourage biological development | TGFß3: A gene variant that, among other things, converts inflammatory T Cells into anti-inflammatory T-Cells - Research into exosomes is happening for a number of purposes; male and female sexual functioning/revitalization, joint regeneration, and facials. Studies into their viability for biomarkers, Lyme disease treatments, rheumatoid arthritis (RA), and COVID-19 are also being looked into. - Exosomes from follicular stem cells, the logic goes, facilitate hair growth References

Exosome Therapy: Are exosomes safe?

- The safety and tolerability of MSC-derived exosomes is something that we do know. Exosomes are an acellular product. That means that there is no chance of rejection or inflammatory response. - ExoFlo exosomes are sterily filtered and tested to meet the United States Pharmacopeia (USP<71>) sterility requirements as well as extracellular vesicle characterization to deliver a minimum of 10 billion exosomes per milliliter (mL) - Exosome products are also regulated by FDA. As a general matter, exosome products intended to treat diseases or conditions in humans require FDA approval. - There are currently no FDA-approved exosome products. - In late 2019, several patients in Nebraska using placental-derived exsomes experiencesd serious adverse effects including bacterial infections. These are different from the mesenchymal-derived exosomes, Exoflo, used in our clinic.

Exosome Therapy: Are there any clinical research studies on exsomes?

There is anecdotal data on the use of exosomes for various conditions. There are very few published clinical research studies on exosomes. There are, however, several current clinical studies being conducted on the use of exosomes for various indications including COVID-19.

Exosome Therapy: How do I know if I am a candidate for exosomes?

- You are thinning or receding or You are experiencing pattern progression after a hair transplant. - You have been told that you are not a good hair transplant candidate - You are hesitant to commit to having a hair transplant due to concerns of unnaturalness - You are concerned with the possibility of additional future loss. - Women with female pattern baldness, especially if other therapies have failed.Exoflo therapy is especially promising for women as they often don’t have the necessary preserved donor to undergo a hair transplant. And so many times the only treatments available to them are either ineffective or bring unwanted side effects. - Women with generalized thinning and focused areas of thinning. - You have Traction Alopecia that has resulted in thinning (not bald) areas of your scalp. - You have contraindications for platelet rich plasma therapy. - You fully understand the risks, side effects, and benefits of exosome therapy. - You have discussed all other hair loss treatment options with Dr. Osei-Tutu.

Exosome Therapy: How is the exosome procedure performed?

The exosomes are mixed into a saline solution. A ring block is placed to make your scalp numb. Then the solution containing 10-20 billion exosomes is injected into the areas where you are thinning. It takes less than an hour and there is minimal downtime (occasional short-term scalp and facial swelling). Microneedling is done after to the procedure. The only preparation that you need is to be off NSAID’s for 3 days prior and 2 weeks after.

Exosome Therapy: How long does it take to see improvements?

Noticeable results have been reported in as little as 30 days. Since this is such a new treatment, it’s unknown how long until the peak effect is seen, or how long the results will last. It is a revolutionary regenerative hair therapy that addresses the root cause of hair loss. It is non-surgical treatment with minimal downtime and minimizes the amount and need to transplant hair.

Exosome Therapy: How long do the results of exosome therapy last?

We just don’t know. Exosome therapy for hair loss is too new to be able to state a certain expectation. The results could last a year, 18 months, 2 years, 5 years, longer. We really just don’t know.

Exosome Therapy: What type of exosomes are used?

- We use Direct Biologic Exoflo. Exfo uses bone-marrow derived mesenchymal stem cells (BM-MSCs) - Peer reviewed published studies clearly indicate that BM-MSCs have a much higher safety profile and yield higher quality exosomes that deliver a more favorable profile of signaling factors vs. perinatal derived MSCs. - Bone marrow derived MSCs are a much more characterized cell source. Over 63,000 peer reviewed papers have been published on bone marrow derived MSCs vs. up to 1,200 on perinatal derived MSCs. - Given the reported differences in safety, quality, and efficacy of exosome products, it is important for physicians to thoroughly investigate the exosome product being considered.