Exosomes, Direct Biologics

Exosomes and Hair Loss Update

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When I published my first post on exosomes and hair growth in late 2019, I got numerous requests for an update. However, the US FDA has since posted warnings about the unregulated use of exosomes for hair loss and other regenerative medicine applications. I was awaiting further updates in relation to product safety and legality.

Update: Check out my new post on exosome suppliers to the hair loss market.

New Exosome and Hair Loss Studies

In comparison to 2019, fewer studies on exosome treatment for hair loss were published in 2020. But at least half of this year was wasted due to shutdowns.

And finally, a September 2020 article on stem cell hair loss treatments has two important notes on exosomes:

  1. There are currently no clinical studies on extracellular vesicle (or exosome) therapy for hair growth.
  2. There are presently no standard effective isolation methods for exosomes.

The second statement above ties in with recent warnings from the US FDA. Irreputable exosome products can cause major side effects or worse.

FDA Regulations

Over the past decade, the FDA has generally been very hands-off when it comes to stem cell and related treatments. This includes PRP, adipose-derived stem cells, SVF and more. The government likely did not want to inhibit the growth of new therapies in regenerative medicine per Dr. Ron Shapiro.

However, we now have problems with the proliferation of unethical clinics. Some use third-party derived exosome products that are poorly processed and can cause side effects and infection. Sometimes, these products may not even contain exosomes! Or they contain 1000s of times fewer exosomes per cubic centimeter (cc) then promised.

One key issue to look out for in 2021 will be updates on 351 versus 361 status. The former is expensive to attain. Technically, exosomes fall under 351. Meaning that they need to be regulated as drugs and/or biologics. Note: I am not 100 percent certain about these technicalities, but the gist of the matter is that one needs to be cautious.

Adding to my delay in writing this post, the initial excitement about this subject matter was perhaps overblown. Exceptional results have not been as frequent as expected and advertised in some YouTube videos out there. I also wanted to see if more doctors would jump on the exosome bandwagon in 2020. And if more studies and patents would be published on this topic.

Exosomes for Hair Loss Feedback

I have received feedback and updates from a number of doctors since I published the original post in 2019.

Dr. Jerry Cooley is one of the early pioneers of using exosomes to treat his hair loss patients. His website has an updated section on this subject with a number of before and after photos. Dr. Cooley uses ExoFlo™ products from Direct Biologics. These exosomes are derived from bone marrow cells. Note that Direct Biologics also market the product as XoFlo™.

According to Dr. Robin Unger, her exosome results are more dependable than platelet-rich plasma (PRP). Moreover, she already gets good results from using PRP to treat hair loss. Make sure to compare growth factors in PRP versus this list of growth factors and proteins in exosomes. Dr. Unger has been using exosomes for more than a year and is currently undertaking a study on their benefits.

According to Dr. Jeffrey Rapaport, “Exosomes are not FDA approved. No guarantees or promises can be made regarding treatment or cures of conditions or diseases with exosomes”. He only uses them for people who have not responded as well as he likes to PRP. Below is one of Dr. Rapaport’s patients before and 3 months after being treated with exosomes for his hair loss.

Exosomes Before and After Hair Growth
Exosome hair loss treatment in a young male. Before and 3-months after hair growth. Source: Dr. Jeffrey Rapaport.

Dr. Rapaport also said that he believes in Direct Biologics. “The company has an IND for using exosomes to treat Covid. This says something for the safety of the product”. Per the doctor, one cannot be sure that exosomes will still be available to treat hair loss after May of 2021. Apparently, that is when the FDA concludes its evaluation.

Note: My hope is that the FDA takes a lenient position on exosome use. But also imposes very stringent requirements on any company seeking proprietary exosome product marketing approval. If there is an outright ban, I would not be surprised if people start going to other countries for treatment. This would be far more dangerous.

According to Dr. Ron Shapiro, the debate over the use of placental versus bone marrow mesenchymal stem cell-derived exosomes still exists. Note that stromal and mesenchymal stem cells (MSCs) can be derived from bone marrow; the placenta; umbilical cord tissue; adipose tissue; molar cells; and amniotic fluid.

Combination Treatment with PRP

Dr. Shapiro is very pleased with his results to date and sent me the below two before and after photos of one of his patients. Note: I always assume that all photos sent to me from any doctor or surgeon are examples of best-case results.

The first photo below is 6 weeks after combination treatment with 5 cc exosomes and PRP. The second photo is another 6 weeks after an additional 5 cc exosomes + PRP + Wharton’s Jelly addition to the treatment.

The results are excellent in my opinion. Note that the second after photo was taken by the patient himself at home, hence the difference in lighting. It is often not possible to get a patient to fly back to a clinic just to get an after photo in similar lighting and background. Dr. Shapiro also sent me closeups of the crown and entire frontal scalp of this patient. All looked great to me.

Week 0, Week 6 and Week 12 Treatment Progression

Exosomes PRP Before After Hair Growth
6 weeks before and after results after 5 cc Exosome and PRP combination hair loss treatment. Source: Dr. Ron Shapiro.
Exosomes, PRP and Wharton's Jelly Hair Loss Treatment
12 weeks before and after results after initial 5 cc Exosome and PRP combination hair loss treatment. Then, at 6 weeks, a second 5 cc Exosomes and PRP injections treatment (with the addition of Wharton’s Jelly). Source: Dr. Ron Shapiro.
Wounding, Follica, Microneedling, Women's Hair Loss

Scalp Wounding for Hair Growth in Females

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A new pilot study on wounding and hair growth just got released online yesterday. The authors found that wounding via Follica’s microneedling device causes new hair growth in women. This is worth reporting because prior research from Follica only entailed studying hair growth in men.

Wounding, Microneedling, Follica and Female Hair Growth
Before and after hair growth photo for wounding via Follica microneedling device in females. Source: International Journal of Women’s Dermatology. Publisher: Elsevier.

In fact, almost all past research on microneedling and hair growth has focused on male pattern hair loss. Balding men are often satisfied with new hair that grows just 1 inch high. Women, on the other hand, often need superior results in order to make for a natural appearance. I did not think that this would be possible via just wounding and intentional scalp injury.

Men are also more likely to be ok with a shaved or thin appearance on the sides and rear of their heads. And of course many men can get away with just shaving their head entirely.

Scalp Wounding Causes Hair Growth in Women

This latest study was undertaken using Follica’s technology. See the company’s press release from today. The lead researchers were based at Harvard University and at Massachusetts General Hospital. The team was led by Dr. Maryanne Senna.

The study showed that wounding leads to at least some hair growth in all women. See discussion further below. All of the 11 females in the study suffered from mild to moderate female pattern hair loss (FPHL).

The main limitation of the study is obviously the small sample size. All 11 patients underwent six treatments with Follica’s Hair Follicle Neogenesis (HFN) device. Each treatment lasts for just a few minutes. The scalp skin wounding creates an “embryonic window” that allows new hair follicles to form from epithelial stem cells.

Two of the patients were also using Spironolactone for their hair loss during the trial.

Minoxidil Addition

The study summary initially states that on non-treatment days, participants applied a topical “on-market” drug. However, later on in the study, it states the following:

“Subjects applied topical minoxidil 5% foam nightly to these areas for the duration of the trial. Topical minoxidil foam was not applied on treatment days.”

So I guess it is Minoxidil and nothing else in Follica’s topical? A lot of online discussion in the past centered around the addition of valproic acid, but this now seems unlikely.

100 Percent Success

  • 10 out of 11 patients reported perceived improvement in hair growth at the end of study.
  • All 11 patients demonstrated improvement in physician-graded Sinclair scores after 4 months. The average improvement in Sinclair grade was slightly more than 1 full integer reduction.

The Sinclair Scale for female pattern hair loss was developed by Dr. Rodney Sinclair of Australia. A more commonly used measure in women is the Ludwig Scale. For men, the most common way to classify degree of baldness is the Hamilton-Norwood Scale.

Also see Follica’s announcement of these findings on Twitter.

According to CEO Jason Bhardwaj, their product has the potential to address both male and female androgenetic alopecia. And this study makes clear that the device works well with both longer and shorter hair.

Follica plans to advance its lead program for male pattern hair loss into Phase 3 trials in 2021.