Question 1

What are extracellular vesicles?

Accepted Answer

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.

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– 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

Question 2

Types of extracellular vesicles

Accepted Answer

– 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.

Question 3

Are there any clinical research studies on extracellular vesicles?

Accepted Answer

There is anecdotal data on the use of extracellular vesicles for various conditions.
 There are very few published clinical research studies on the use of extracellular vesicles (exosomes) on hair loss.

There are, however, several current clinical studies b(https://www.clinicaltrials.gov/ct2/results?cond=&term=exosomes&cntry=&state=&city=&dist=)eing conducted on the use of exosomes for various indications including COVID-19. 
There are currently no FDA approved extracellular vesicles/ exosomes for hair loss and  there is an FDA warning (https://www.cdc.gov/hai/outbreaks/stem-cell-products.html)about these products

Question 4

Are there any clinical research studies on the use of extracellular vesicles for hair loss?

Accepted Answer

Although there have been many anecdodal reports on the clinical efficacy of exosomes on hair loss, there is only one published case report t(https://pubmed.ncbi.nlm.nih.gov/32501792/)o 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.

Question 5

Are extracellular vesicles safe?

Accepted Answer

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.

Question 6

How long does it take to see improvements?

Accepted Answer

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.

Question 7

How long do the results of extracellular vesicle therapy last?

Accepted Answer

We just don’t know. Exosome therapy for hair loss is too new to be able to state a certain expectation.

etracellular vesicles (exosomes)

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