Exosomes and Hair Loss Update

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.

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 comprehensive list of growth factors 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.

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.

Part 2 of this post will come next week.

69 thoughts on “Exosomes and Hair Loss Update”

  1. Unrelated but – admin, have you heard that Rivertown Therapeutics has gone out of business? So frustrating, their before and after photos were so promising.

    1. Yet another one bites the dust! I wonder if the remaining serious contenders get a small staff together and drink in celebration whenever this happens – similar to the 1972 Miami Dolphin players celebrating together when the last undefeated NFL team has their first loss of the season.

  2. One of the Doctors on YouTube mentioned that the needle puncturing the scalp may also help in regrowth, much like Follicas wounding method

  3. I’d be upset if exosomes regrew a full head of hair and then the FDA steps in and now regulates it and then I can’t get another injection until years later when they approve it I would be very upset. but exosomes don’t regrow a full head of hair or even do much so I’m not upset. Just so you guys know I don’t like FDAs regulations (for certain things) to much government regulation is not good. And the clinical trial process is way to slow.

  4. Mjones, I deleted your scam allegation comment against the clinic. I clearly said in the post that the 3 month after photo is in different lighting because the patient took the photo himself at home. Most patients will not fly back to a clinic to have after photos taken in similar light and background settings as before photos.

    His hair is lighter, and perhaps this is due to the lighting change or perhaps he stopped dying his hair. I am just glad it is not darker, or else people would accuse me or the clinic of a double scam lol Dr. Shapiro has treated over 100 patients with exosomes, and he sent me what might be one of his best results. Also note that the guy received exosomes, PRP and Wharton’s Jelly via two spread out treatments.

    1. hello- would it be possible to advise how many billion exosomes were in the 5cc vials they used ? Thank you

  5. And I should also mention it’s been known that former heads of the FDA are big pharma board members. That could be why we still have Finasteride. Just something to think about.

  6. Fair enough admin:) I still dont believe in prp or exosomes… but I’ll slow my role on saying it’s a scam.

    Woofy- propecia works well. I dont understand your comment about how it’s still available because the head of fda is pharmaceutical ties? It’s on the market because it’s a solid drug for mpb.

    1. Hi Marc yeah Finasteride works very well I agree. What I’m saying is about the former FDA heads they are on the boards of pharmaceutical companies and they most likely profit from drugs being sold and it wouldn’t surprise me if some get paid Off of Finasteride sales and do not want any other approaches to potentially cure AGA they like Finasteride because it’s a maintenance drug not a cure and it doesn’t regrow a full head of hair so they like how we keep coming back to the pharmacy to buy more prescriptions. Now this is all speculation I could be wrong but nothing is impossible. Lol

      1. @woofy, mjones, what dosage of Finasteride you taking? I’m currently split 5mg to quarter and taking them the positive effect hasn’t kicks in yet, been taking around 4mths mark now.

  7. Also with the exosomes there is no reason to take the exosomes out of the male pattern baldness industry to protect the patient if the patient uses his brain and does good research then he won’t get scammed. the FDA only needs to regulate the companies and product and make sure what they are selling is Pure and legit but no need for clinical trials.

    1. Woofy you really have high hopes for stemson theraputics , there going to crash and burn just like Dr tsuji. You know Dr tsuji claimed to have cloned human teeth and salvery glands way before he started working on hair cloning, my point is he never showed proof or tried to market growing teeth and glands, not only is the hair loss industry a huge scam but so is stem cell research after 16 years of stem cell research nothing has come from it absolutely nothing .and don’t confuse me with mjones.

      1. Marc why are you comparing stemson to tsuji? Alexey is not tsuji. Just because tsuji didn’t deliver doesn’t mean stemson and Alexey won’t deliver.

        1. Becuase it’s stem cell research and nothing has come from stem cell research after almost 20 years of research. Woofy97 just look up prop14 in California it passed in 2003 they said in 5 years there would be medical breakthroughs, absolutely nothing has come from it.

          1. Wake up. Nobody will get real medical healing. It’s all big Pharma outdated toxic pill crap. Anybody that develops anything they get rid of.

    1. Both 1mg and 5mg selling the similar price here in Australia, for affordability reason I went with 5mg and split them into 4 part, and take each quarter everyday, I assume they workout to be same as taking 1mg?

  8. Did anyone notice Floyd Mayweather Jr got a hair transplant in turkey , that’s just proof that if a billionaire can’t get hair cloning OR something close to that, then a true meaningful cure is decades if not impossible. Woofy97 let me ask you a question what do you think of spacex going to Mars in a few years and of electric vehicles?

    1. Elon Musk himself have male pattern baldness, I reckon if he want to change this he has the brain resources and money to bring mpb to an end for all of us.

      1. Elon musk def was balding bad in late 90s. He’s got a good rug or some great hair HT. His hairline is Goodnow. Somebody needs to tell ELon to make a Tesla hair loss cure ha

  9. Marc I’m all for spacex going to Mars In a few years I think its time we start exploring other planets. And as for electric vehicles I think they are cool I would buy a Tesla if the charging time is fast and they don’t have a lot of expensive mechanical problems.

    1. Alright woofy you answered my question correctly I thought you were going to say Tesla is the future no it is not electric vehicles are way over hyped and so is spacex there’s no way there going to Mars in a few years spacex will land humans on Mars in the 2030s , my point is elon musk is a con man pushing old technology like it’s something new. And people are fanboying out on him, much like your fanboying stemson therapeutics. You stated that in 18 months there starting trials no word of human trails just trails. I’ll be seeing you in 2 years and I’m going to tell you I told you so, I wonder when follicle thought starts to mention tissuse your going to say guys this the cure too. Much like Replicel and Dr tsuji and histogen and follica

  10. Blog is called “hairlosscure2020.com”. Most recent post and scientific progress on 16th of December: exomones and hair loss update.

    Stop having hope guys, there won’t be no cure for us anymore. Learn to live with it somehow, having hope is dangerous, I had it since I started reading this blog in 2016 and I didnt accept the issue of hairloss. Which I luckily did a while ago and life is still bad, but not depressing bad anymore.

    1. How do you know there won’t be a cure?? Are you a graduate of Hogwarts???
      Just because you have no hope anymore doesn’t mean no one should…

      1. no one knows what is the progress in the work of Tsuji or Stemson, there is progress and it cannot be denied, if there is no medicine for us, let it be for the next generations

      2. You don’t have to be a genius or a wizard to understand how difficult it is to find a cure … maybe one day but that day is not around the corner of our time …

    2. Most likely you are right, I have been hoping for almost 30 years … in the meantime the past time will never come back …
      live your life guys, with or without hair.

  11. I agree with Red and Lorence. Live your life and accept your genetics. Hop on big 3 as soon as you notice shedding. Dont hope for a cure! It ain’t going to happen. Just potential baby steps with slightly better results or similar to big 3. To this date we have not seen any company show us a before after pic of a nw7 to nw1 with any treatment. Even those high risk side effects drugs that get shut down….only thing was Jak for Areata and some random super responders to big 3 and dermaroll but I think those redit guys are a scam. Fue transplants can get you coverage but those are not dense thick nw1 coverage. We are decades away from curing mpb.

    1. “Follow your lives and have no hope” says the one who does not stop entering hair loss pages daily. Set an example and leave and no more. thanks

  12. Rodri I have no hope for cure but I do believe we will get better treatments this decade. I join this site to see what the latest treatments are what I can stack up on to addition of big 3. Plus several people mentioned things that work for them that I have used like certain compound minox, and diets etc. This site is also a place to help one another with our experiences. So dont try and act smart with your comments bro. I am telling those guys that think a cure is going to happen because they believe it will….is a bad way to think. Just giving them advice to hop on what’s available and save the most hair they can by being realistic.

    1. No mjones, you are just blowing off steam and you are very tired with your daily repetitions. Do you think people don’t know what exists now? Obviously they do but you are always saying the same thing over and over again on all the hair loss forums.

      1. I’ll keep telling them and telling them until they use it. Some people need the extra push to wake up and realize current treatment works and to use them instead of hoping for a cure in 2021.

  13. still waiting for your answer Marc. why are you comparing stemson to tsuji? Alexey is not tsuji. Just because tsuji didn’t deliver doesn’t mean stemson and Alexey won’t deliver. I’ve seen this type of thinking many times by multiple users and it’s just not healthy and doesn’t make anysense I don’t mean to be rude but it’s true.

  14. My current thoughts on a ‘cure’ ——————————-> ?

    I don’t like xmas because the bauble decorations remind me of bald heads.

    I’ve had a few…(I’ll see myself out). Nite.

  15. @sunnykim that’s funny man. Maybe lay off the egg nogg for a couple days lol…I can see you guys are very frustrated at the lack of progress with this challenge we face. The year is just about finished and nothing to show. I get it…but I think some of you make a good point to live your life no matter what. If people treat you differently because your balding or bald then I say f them. Dont be around people like that..and that includes women that act like jerks. Dont let them get you down. Stay strong boys, let’s all do something nice for someone else over the holidays!

  16. Hey, admin I’m sorry to bother you about this but do you think you could try and get another interview with Alexey T at stemson? or anyone at stemson? I’ve tried to contact them but i never get a response.

  17. Has Tsuji really failed?
    I see a lot of comments in recent months about that.

    Do those comments mean he failed to deliver in 2020 only?
    Or do you mean Tsuji’s technology has failed completely, forever?

    Is there any official source affirming that, or is it all based on assumptions?


  18. It appears that organ technology’s has gone bankrupt but that doesn’t mean failure. It only would mean failure if it causes cancer or doesn’t work at all and that’s not the case with tsuji we haven’t heard any of that bad news just the bankruptcy. And I don’t think we have gotten an official statement from tsuji himself it would be nice if they communicated more but they don’t, but I’ve moved on. Stemson seems like a better company.

    1. A reader got the below response from Kyocera and e-mailed it to me. Not as bad as I expected, although perhaps still false hoping on my part. Key words = “completed” and “postpone”.

      This is XXXYYY from Kyocera Corporation.

      Thank you very much for your inquiry regarding the joint research project with RIKEN and Organ Technologies.

      The joint research agreement with RIKEN and Organ Technologies on “Treatment of alopecia by hair follicle organ regeneration” ended in March 2018. In the meantime, our company had completed the development of hair follicle cell processing technology.

      Our company had planned to consider commercialization based on the results of clinical research and experiments led by Organ Technologies, but as Organ Technologies decided to give up clinical research and experiments this time, our company decided to postpone the commercialization of hair follicle regeneration as of now.

      1. One should read between the lines, organ technologies gave up because hair cloning isn’t possible! Everybody needs to microneedle and take propecia asap!

      2. Admin please Tell me exactly because Every Little Information is Importanz in that case:
        – What was the question to kyocera?
        – When got the Reader the answer of kyocera?

      3. Why would organ technologies decide to.give up clinical research and experiments if it was anywhere close to working? :) i guess it wasn’t

  19. Interesting response from kyocera. They finished the technology and organ decided not to commercialize at this time. If they had a blockbuster hair cloning cure they would rush that mofo to the market. I think they failed….no pics of success or anything. Time to move on. Maybe they will come back in the future to retry it.

    1. Thanks for the video Lorence!
      Funny thing I caught in that was in the comments, there goes Jan talking sh*t about Tsuji again. Jan trolls everything that mentions Tsuji. Lol I’m almost 100% it’s the same person that comments on this site. I can see why Woofy97 was trying to get him/her banned.

  20. I don’t have time to wait on these pharma companies. I have 4 video consults set up in January for an FUE, 3 domestic (USA) and 1 abroad (Eugenix in Mumbai).

    1. All comments should be awaiting admin approval unless someone is one of the few dozen old-timers who was granted automatic approval in the past due to posting generally useful and mature comments. Maybe you got lucky so far. Sometimes the interface does strange things with switching permission settings, especially if you post from different computers and phones. At some point, I will just require all comments to be approved by myself or a moderator first.

      Marc has been posting too many sarcastic, repetitive and accusatory comments lately (I deleted a few) so I do not want you to engage with him unless blog post subject matter related (in this case, exosomes). I think he is mostly trolling on here considering that he thinks there will be no cure or great treatment for decades.

  21. Direct Biologics is by far the best company to get exosomes from . I myself , as well as many family members have benefitted in MULTIPLE ways from this remarkable treatment . I had excruciating pain from a broken shoulder and arm last year , and received an injection of exosomes straight into my shoulder joint . The very next day my pain was gone and hasn’t returned . No more tramadol for me . What a gift that was !
    This is why Big Pharma wants these miracle treatments, such as exosomes , to disappear.

    My parents have received IV exosomes as a regenerative medicine treatment, and my father especially has said he never has felt better . You can even see the difference just by looking at him . My daughter has received exosomes in her scalp for hair loss and has experienced lots of new growth and is very pleased . My cousin received IV treatment for her arthritic hands and could tell the difference in the pain by the end of that very day . ( I had the same and my arthritis has disappeared as well . Such a blessing .)
    As of today , my cousin has NO pain. Nor do I.
    Countless patients have been given relief by a doctor I am well acquainted with and trust completely , and each and every one of them have been thrilled to have something natural , 100% safe , and not pharmaceutical. Many are repeat patients . All of the exosomes come from Direct Biologics and they have never failed in their quality . The FDA needs to get on board with this treatment and insurance companies as well , because it’s not cheap . Exosomes need to be covered . Because they heal .
    I agree that they need to be a quality product . Direct Biologics is . You simply can’t lump them all together and shut down the whole industry.

  22. ExoCoBio Asce+ HRLV are not from humans exosomes but from rose stem cells… I am wonder it it can work ??

    And in the list of miRNA in rose stem cells exosomes there are some miRNA which have negative for hair regrow ….

    But it seems there also “bad” miRNA in exosomes from humans like MSC … So I don’t know…

    What do you think about this ?

    Rose stem cells exosomes and miRNA :
    Biological Function of Exosome-like Particles Isolated … https://www.biorxiv.org/content/10.1101/2023.10.17.562840v1.full.pdf

    List of positives and negatives exosomes for hair regrow :

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