HCell Exclusive: Before and After Hair Growth Photos

Last week I had the opportunity to join a video conference with the HCell team to discuss their therapy aimed at multiple forms of alopecia. The HCell company emerged on the internet around mid January 2018 through the announcement of their Orphan Drug Designation from the FDA to treat pediatric alopecia areata. That press release also mentioned that HCell has a therapy aimed at androgenic alopecia. I learned a lot about HCell during our discussion including the biological components of the treatment and the fact that this treatment is currently available to patients in Asia. 

HCell Alopecia Therapies

HCell currently has two therapies in its pipeline, HCO17AA for pediatric alopecia areata and HCO100 for female androgenic alopecia. Both therapies are based on the same therapeutic components, PRP/Plasma and basic fibroblast growth factor (bFGF). I believe that different ratios are used when treating either androgenic alopecia or alopecia areata. The designations given in the company’s pipeline are due to the company’s desire to focus on these designations first based on market potentials for unmet needs and regulatory pathways. However, the company has other designations that will also treat adults with alopecia areata and men with androgenic alopecia. I was initially surprised to learn that PRP/Plasma was involved in the therapy, however was interested to learn more about bFGF and how these therapies are designed to work. HCell theorizes that their treatment is likened to the metaphor of trying to grow a crop in unfertile soil. Their aim is to make the soil, or scalp, healthy to produce improved growth of hair through the injection of PRP, Plasma, and bFGF.

HCell Before and After Results 

Of course, the main focus on every alopecia treatment is what the results look like. I was shown several case studies during the HCell slide deck presentation as well as other results images from the presenter’s computer. Here are some images from the HCell slide deck. Click on any image to view it full screen.

HCO17AA


HCO100



I find these results interesting. Alopecia areata cases are typically easier to review because their is such a contrast in before and after images. There are more variables to consider when reviewing regrowth in androgenic alopecia photo results. The presenter did mention that these photos of HCO100 were taken early on and the doctor has improved his technique for capturing photos. Another HCell team member suggested that the doctor could provide video documentation for further cases. I agreed that would be helpful and I hope to receive more photos from the HCell team to share in the near future.

Company Background & Development

Here’s a brief overview of the company’s history and development from what I gathered during the video conference. The treatment originated from the office of Jaehyun Lim, MD, PhD of South Korea. He also serves as the CSO of HCell. Jaehyun has treated over 500 patients with this novel formulation and has observed positive results. Thus, along with his brother Jaebum Lim who serves as Chief Business Strategist for HCell, they have endeavored to bring this therapy to North America through the US FDA. The decision was made to approach alopecia areata initially and then female AGA because of the significant unmet needs in those patient areas. The HCell team also comprises William Jang J.D., interim CEO and Karl Kim, COO.

HCell is in a unique situation as they are a company seeking FDA clinical approval for their hair growth treatments while these treatments are actually available to consumers in another part of the world (South Korea). This should, if anything, help them produce an unlimited amount of data to prove their efficacy. If you are considering inquiring with HCell about receiving these treatments in South Korea please use your own discretion.

Feedback

I know that many of you will have questions about HCell and its treatments. So, in order to help you get efficient answers so I am inviting Karl Kim of HCell to respond to readers’ questions in the comments section below. 

87 Comments

  1. Follicle Thought on January 30, 2018 at 6:38 pm

    As always this thread is for civil discussion only.

    Feel free to comment on the photos and ask questions.



  2. Natasha Atanaskova Mesinkovska MD PHD on January 30, 2018 at 6:44 pm

    Very interesting data.

    Will the alopecia areata pediatric population treatment consist of repeated scalp injections and blood draws?



    • Jaebum Lim on January 31, 2018 at 10:04 am

      Dear Dr. Mesinkovska,

      The treatment is consist of multiple series of injections on the scalp. The number of the injections can be varied depending on the size of the target area.

      Jaebum Lim,
      CBO
      Hcell.net



  3. John on January 30, 2018 at 10:01 pm

    When will HCell be available in the USA?



    • Jaebum Lim on January 31, 2018 at 10:06 am

      Hi John,

      HCell is not yet available in the USA. It requires FDA process to be marketed.

      Jaebum Lim,
      CBO
      Hcell.net



    • Monique on January 31, 2018 at 12:23 pm

      How is this different than the many types of prep done here in the USA; for example prep with a cell? Cost and ability to travel to South Korea ? It will take years for fda approval, and it doesn’t actually need fda approval to be done here. Thank you!



      • Jae H Lim M.D, Ph.D. on January 31, 2018 at 7:51 pm

        Monique,

        As you mentioned there are various types of treatments. One of the main difference is that heterograft’s (calf bladder- a foreign body) absorption speed is very fast, which means that the effects of the injection does not last long before the scalp returns to original state. Also, the Vascularity is ineffective.

        The main difference is that HCell uses Autograft, which sits atop of the scalp instead of absorption, it creates a thicker scalp through Neovascularization and Anastomosis, which HCell believes is an ideal environment for hair follicles to grow. Not only does this mean the effects of the injection lasts longer (Since the injection is not absorbed into the skin to return to the original state) but effective.

        Depending on where you live, prices may vary for trips to S. Korea, but we are currently working to provide a medical service for those patients who would like to travel to S. Korea for treatment. For more information, please contact luana@hcell.net

        I’m not too sure what you mean when you say that FDA approve is not needed to be done, but the HCell Team is working hard to bring HCell to more patients suffering from Alopecia.



        • ebt on February 12, 2018 at 12:45 am

          Hi Dr. Lim,

          The pictures look great, and I’d consider them a satisfactory cure.

          I guess what Monique was saying and what I was wondering too is some clinics use ACell w/ PRP, a few others use bioD, and they do it legally. A Dr. in the USA has a fair amount of latitude to combine approved materials into their own process and offer a proprietary treatment in their own practice. If the process doesn’t involve a new drug or device, then why couldn’t you start offering the treatment now out of a sole practice in the US? Thx.



      • Karl on January 31, 2018 at 9:07 pm

        Hi Monique,

        Thank you for your interest.

        You’re absolutely correct! There are various types of blood-based hair restoration treatments currently being performed in the U.S. (i.e. PRP and PRP/Acell). Outwardly, they share several similarities with HCell treatments but differences are innumerable.

        For example, one of our key ingredients, bFGF, is a human recimbinant that’s derived from cell culture. Whereas, Acell powder used by a handful of clinics in the U.S. is an extracellular matrix derived from pig’s urinary bladder. To date, these other blood-based hair restoration techniques operated by stand-alone clinics vary widely in their outcomes and are markedly inconsistently.

        At HCell, we’ll be properly following through the U.S. FDA regulatory process, as our paramount goals are both efficacy and safety. Further, in order to protect our IP, we have obtained U.S. and South Korean patents on both the composition (formula) and methodology (process)—and international patents pending.

        Karl
        COO
        HCell.net



  4. Steve on January 31, 2018 at 12:18 am

    When will HCell be available in the USA?



    • Jaebum Lim on January 31, 2018 at 10:06 am

      HCell is not yet available in the USA. It requires FDA process to be marketed.

      Jaebum Lim,
      CBO
      Hcell.net



  5. QQ on January 31, 2018 at 6:34 am

    Wonderful article. The results are stunning. My question: did they communicate about a release in Europe ? I’m not aware of FDA approval differences between the USA and EU. Would they also need the product to pass other test for EU FDA clinical approval if they plan to bring the product in Europe?

    Thanks and congratulations for the amazing job you’re doing with this website.



    • Jaebum Lim on January 31, 2018 at 10:08 am

      HCell is not yet available in the USA nor Europe. It requires FDA process in the USA and EMA for Europe to be marketed.

      Jaebum Lim,
      CBO
      Hcell.net



  6. Paul on January 31, 2018 at 7:56 am

    So, it it available for the people with just common androgenic alopecia as a treatment in S. Korea? Can we travel to S. Korea for the treatment and for how long? What is the price?



    • Karl on January 31, 2018 at 11:28 am

      Hi Paul,

      Thank you for your interest. Yes, HCell treatment is currently available in South Korea for androgenic alopecia patients.

      The treatment is comprised of three one-hour sessions, 28-days apart, which is to help normalize your hair growth cycle.

      Currently, the cost is being evaluated on a case-by-case basis. Our goal is to bring the treatment to the U.S. via the FDA approval after which we’ll be able to standardize the cost.

      Karl
      COO
      HCell.net



      • Jarod on January 31, 2018 at 5:43 pm

        Hello Karl,
        You mention the treatment is available in South Korea. Would you accept patients from US & Europe to travel to your clinic in South Korea to get treatment done?
        If yes, can you provide necessary details (email, website…) to make appointment?
        Thanks.



  7. Ben on January 31, 2018 at 8:51 am

    How many treatments are required to see results? Will you need to have treatments monthly? Weekly? Annually ?



  8. Karl on January 31, 2018 at 11:52 am

    Hi Ben,

    Thank you for your interest. The HCell treatment is comprised of three one-hour sessions 28-days apart which is to help normalize your hair growth cycle.

    We do not require additional treatments after the third session; however for maintenance, an optional one-hour session may be recommended two years later.

    Karl
    COO
    HCell.net



  9. Paul on January 31, 2018 at 3:53 pm

    Bring it to Europe as well ! Why only the USA?



  10. Colum on January 31, 2018 at 5:06 pm

    Are there any side effects from the injections?
    Is hair regrowth projected to continue to advance beyond the 3rd injections, or is this the limit of progress? Can the guys in the photos expect to have even thicker hair beyond the 18 week period? Is there any possibility of a baldy regaining a full head of hair in time with these injections?



    • Jae H Lim M.D, Ph.D. on January 31, 2018 at 10:40 pm

      Hi Colum,

      There are no major side effects. However, 5% of patients do experience swelling on the forehead for the first three days after the injection, which de-swells after a couple of days. It really depends on the type of Alopecia. However, it is definitely possible to regain a full head with the injections. With time, the hair will continue to grow beyond the 18 weeks shown, even after the last injection – which is the beauty of HCell.

      Jae H. Lim M.D, Ph.D.
      CSO of HCell



    • Karl on February 1, 2018 at 1:20 am

      Hi Colum,

      Please note that we do not have the supporting scientific data but our (non-scientific) internal data supports the finding that the side effects were of the temporary variety, including but not limited to: itching, scaling, minor headache and dizziness. Our goal is to thoroughly test the efficacy and safety (both short term and long term) via the FDA regulatory process prior to bringing HCell treatments to market in the U.S and other countries soon thereafter.

      Yes, hair regrowth is projected to continue beyond the third session and beyond the 18 week period.

      Lastly, there are too many physiological variables so we cannot claim that HCell treatments could help someone bald regain a full set of hair; however, our internal data supports the finding that all of our patients have shown to experience varying degrees of noticeable hair regrowth.

      Karl
      COO
      HCell.net



  11. Luana on January 31, 2018 at 5:06 pm

    Hi Paul,

    We are currently focused on the US, however, it would be fantastic if HCell became available in Europe! We are working diligently and we hope one day, we’ll be able to treat patients around the globe.

    Luana
    Director of PR
    http://www.hcellinc.com



  12. Dr. Amnon Gonenne on February 1, 2018 at 1:46 am

    Sounds intriguing. I have a few questions:
    1. Was the research published anywhere? If not, it would be useful to publish it especially now that you have patent protection.
    2. What is the duration of the effect on hair growth? Does it require future “maintenance” by additional injections?
    3. Did you test for possible synergy with Rogaine?
    4. Did you notice any adverse reactions?
    5. Is this treatment regulated by the Korean FDA (or its equivalent)?

    Finally, as a former CEO of several US biotech companies, I commend you for choosing (and receiving!) the pediatric Orphan Drug Designation to obtain approval in the US market.



    • Jae H Lim M.D, Ph.D. on February 2, 2018 at 2:36 am

      Dear Dr. Amnon Gonenne,

      Thank you! We are so excited for our ODD grant, and we are so excited for this milestone for HCell.

      I’ll answer your question in sequence as you have asked:

      1. We haven’t published our research result to anywhere, but are planning to. We are currently waiting to conduct some important research which we have not published yet as we are still in research.
      2. The growth first starts at 3 months in the zoom up views, (x10-30) and to the naked eye in 9 months. Our protocol is that we follow up every 3, 9 and 18 months after the last injection.(min) Normally, we do not need any additional injections. Since HCell has been around for about 4 years (since our initial establishment) we have kept our follow ups to our initial patients and have seen great results, which has shown that there are no additional injections required for “maintenance”.
      3. I didn’t recommend any other drugs except Minoxidil with HCell as I thought it could work in conjunction, creating a synergy effect for HCell, for its vasodilation property; however, this was not the case. As the main concept of HCell is thickening the scalp and enhancing the vascularity on the scalp with neovascularization and anastomosis, it did not work with each other but the opposite; the results were unpredictable. For this reason, I do not use Minoxidil with HCell anymore except for very limited patients (if any).
      4. We did find some adverse reaction such as:
      1)5% of patients who experience swelling on top of their forehead, which is de-swelled after 2 to 3 days.
      2) Patients who feel an itching sensation after a couple of days, which then is healed by spraying steroid for one or two days.
      3) Lesser than 1% of patients may experience dry patches, and dry spots for 2 to 4 weeks. This is because we have suddenly rapidly increased the thickness of the scalp, causing the skin to react accordingly. (Similar to a paint on a balloon, which has been painted, dried and then spontaneously blown up in size. As a result, the dried paint becomes flaky, just like the outer layer of the skin)
      4) Patients who have stopped oral medication has experienced what it seems like an increasing hair loss during the procedures directly prior to the procedure. This is done when the medication is stopped immediately before the treatment. Once the oral drug is stopped, the results does too. Likewise, we found that as the oral drug is stopped and the treatment commences, it is hard to normalize the hair follicles even after 3-9 months. My hypothesis is that since there are two types of hair: normal (bigger and thicker hair) vs. fragile (thin and can be pulled out easily), the unhealthy hair follicles are unable to stay on the scalp (resulting in hair falling out) as the regrowth of the “normal/ healthy” hair follicle grows after HCell Treatment. For a little while, it may seem that there is an empty scalp, as there is lots of fragile hair loss, and regrowth of healthy hair at least, to the naked eye for 3 months following the HCell Treatment. However, in zoom- up view (x10-30), we are able to observe the new hair growth, which then is not fragile but heatlhy.
      5. Yes, the treatment does follow the Korean FDA and or its equivalent.

      it would be great if you are able to contact me directly at jhlim@hcell.net , I would love to answer more of your questions!

      Dr. Jae Hyun Lim M.D, P.h.D
      CSO of HCell



  13. WHL on February 1, 2018 at 2:37 am

    Is this treatment effective for frontal hair-loss, along the hair-line and temples?

    Do you have an approximate price range?

    Do you envision this treatment becoming available in other countries in SE Asia, inc. Japan in the near future?



    • Karl on February 1, 2018 at 8:27 pm

      Hi WHL,

      Thank you for your interest!

      Our internal data supports the finding that patients with frontal hair loss along the hairline and temples have shown to experience varying degrees of noticeable hair growth.

      We have patents pending in many other countries for the purpose of making our treatments available internationally, including but not limited to Japan and SE Asia.

      The pricing of HCell treatment is still to be determined. Please note however, our team in the U.S. is focused solely on advancing through the U.S. FDA regulatory process, less marketing for treatments in South Korea. However, at your discretion, please feel free to consult directly with the HCell clinic in South Korea, including pricing and traveling logistics. Please use this contact email for more information and next steps: replyinquiries@gmail.com.

      Karl
      COO
      HCell.net



  14. Josh on February 1, 2018 at 1:43 pm

    This is absolutely promising stuff. I’m really surprised I haven’t heard about this before. Just a few questions.

    I know you guys have said it will be possible for people to travel to S. Korea to get this treatment. Exactly how will this process work considering injections need to be administered 28 days apart?

    How much will this procedure cost?

    You guys say after the 3 injections no other follow up treatment will be needed other than an optional maintenance treatment 2 years later. Does this mean the follicles will become DHT resistant? Or does the injection basically prevent DHT from attacking the follicles?

    If a person is maintaining hair currently on Minoxidil and Finasteride, will they need to continue those treatments or will it be possible to cease treatment?

    What is the earliest this will be offered to non-Korean consumers who want this treatment and are willing to travel to S. Korea for this?

    Do you have any more pictures of other results or any data on exactly how much hair regrew in these patients?

    Really appreciate you guys taking the time to answer our questions!



    • Karl on February 1, 2018 at 10:21 pm

      Hi Josh,

      Thank you for your interest. We’ve been working diligently behind the scenes by design in order to properly advance through the U.S. FDA regulatory process, as well as to protect our IP.

      The theory behind three HCell treatment sessions 28 days apart is to help normalize one’s hair growth cycle via thickening the scalp and neovascularization (i.e. natural formation of new blood vessels).

      We hope to study the synthesized effects of using commercially available hair growth products in HCell clinical trials. For patients in South Korea, we’re leaving it to their own discretion whether to use or discontinue using them after their treatments. However, our internal data supports the finding that no new side effects are introduced if continued to be used.

      Please note that our team in the U.S. is focused solely on the U.S. FDA regulatory process in order to serve the U.S. market in time, and internationally soon thereafter. However, at your discretion, please feel free to consult directly with the clinic in South Korea, including pricing and traveling logistics. They may also be able to share additional information. Please use this contact email for more information and next steps: replyinquiries@gmail.com

      Karl
      COO
      HCell.net



  15. Paul on February 1, 2018 at 2:04 pm

    I’m a 30yr, Caucasian male and I live in the US currently but would be willing to fly and stay in SK for a month to try this treatment. Is that something you guys would support? What is the cost of the procedure, risk factors, etc? Can you give more details on how the treatment works? Does this work for male androgenic alopecia?

    Thanks,
    Paul



    • Karl on February 1, 2018 at 8:50 pm

      Hi Paul,

      Thank you for your interest! Majority of 500+ of our patients in South Korea are both male and female androgenic alopecia patients. Also, many patients have traveled from both China and Japan.

      Our team in the U.S. is focused solely on advancing through the U.S. FDA regulatory process in order to serve the U.S. market in time and internationally soon thereafter. However, at your discretion, please feel free to consult directly with the HCell clinic in South Korea, including risk factors, pricing and traveling logistics. Please use this contact email for more information and next steps: replyinquiries@gmail.com.

      Karl
      COO
      HCell.net



  16. Damian on February 1, 2018 at 5:21 pm

    Hi,
    I don’t understand if the patient have to do one session every 2 years for all life ?
    Thanks
    Damian



    • Karl on February 1, 2018 at 9:16 pm

      Hi Damian,

      Thank you for your question. Patients are not required to perform HCell treatment every 2 years. In fact, our patients in South Korea who have had the treatment performed four years ago—which is the timeframe the HCell treatment first became available in South Korea—are continuing to retain their newly grown hair.

      The optional “maintenance session” is purely a recommendation for the purpose of helping to maintain one’s hair growth cycle for many years to come.

      Karl
      COO
      HCell.net



  17. Hairguy on February 1, 2018 at 8:12 pm

    Do you have pictures of this treatment hcell being used by androgenic alopecia males. The pictures shown on here are great! But they are for areata. Please show us some AGA before and after pics please. I would love to see the effects and would probably fly to S Korea to get this done if it can thicken hairline and density.

    Thank you



  18. Karl on February 1, 2018 at 10:46 pm

    Hi Hairguy,

    The third set of photos with 4 case studies shown in this blog are of the AGA patients. Please stay tuned for more case study photos.

    Karl
    COO
    HCell.net



  19. Abdulaziz on February 2, 2018 at 4:10 am

    Hi,

    This treatment is only for people who lives in South Korea?

    I have no issues going to South Korea and have this treatment

    Can you please let me know how to take an appointment to come and have this treatment

    Thanks



    • Follicle Thought on February 2, 2018 at 10:00 am

      Abdulaziz, thanks very much for commenting. Please review the comments in this thread, your question has been answered several times.



  20. Karl on February 2, 2018 at 2:30 pm

    HCell Inc. Disclaimer:
    We would like to further clarify that while we appreciate many interests to undergo the HCell treatment in South Korea where it’s currently available, HCell Inc. (the U.S. and international biotech venture) is not promoting nor marketing HCell products and services on behalf of the clinic in South Korea. Our sole objective is to swiftly advance our products through the U.S. FDA regulatory process to test for safety, efficacy and, ultimately, market approval. HCell Inc. does not, and will not, gain monetary benefits from the clinic performing treatments in South Korea.

    However, at your discretion, please feel free to consult the clinic directly in South Korea for more details, pricing and traveling logistics. Please use the contact email below for more information and next steps.

    replyinquiries@gmail.com

    Karl
    COO
    HCell.net



    • Yoda on February 2, 2018 at 4:57 pm

      Hello Karl,
      I appreciate that Hcell is going thru the proper regulatory process to obtain USA/FDA approval. Where exactly is Hcell currently is the FDA process (e.g.phase pre-clinical, 1, 2 or 3) and when would you estimate completing the regulatory approval process and making the treatment commercially available in the USA? My apologies if you’ve stated a timeline before but I can’t recall seeing this outlined clearly.



  21. Steven on February 2, 2018 at 2:53 pm

    please let me know once FDA approved and you when you start doing procedures in U.S

    thanks and congratulations!



    • Luana on February 2, 2018 at 5:54 pm

      Hello Steven,

      Thank you very much! We are so excited for this milestone.
      Please follow our Facebook (HCellinc) and our Twitter page (HCellinc) for the latest news and updates on HCell as we update regularly.



  22. AJ on February 2, 2018 at 3:18 pm

    Hello,
    I understand that HCell is only focussing on FDA approval, but why not EMA approval at the same time? Or does EMA automatically follow FDA when given approval? It feels like the EU market is a little neglected since there is only a US-team. Second… is HCell already recruiting clinics in EU for this treatment. If yes, also clinics in the Netherlands? (or Belgium/Germany)

    Thank you for giving us baldies hope! 🙂
    Kind regards, AJ



    • Luana on February 2, 2018 at 5:53 pm

      Hi AJ,

      We are Internationally Patented for Composition and Methodology, the EMA approval is another process that is separate from the FDA. As we are still a smaller company, we do lack resources to be focusing on two approvals at once. However, we are so thankful for your enthusiasm and hope that you follow our Facebook (HCellinc) and our Twitter page (HCellinc) for the latest updates as we update regularly.

      Luana
      Director of PR at HCell



      • AJ on February 3, 2018 at 1:50 pm

        Thank you for your reply Luana. I understand your reasons. But do you know how long an EMA approval approximatelly takes after FDA approves? Is that a long process or a matter of a few months? Does EMA consider the results of FDA?

        Kind regards, AJ



        • Luana on February 5, 2018 at 6:07 pm

          Hello AJ,

          The EMA approval is uniquely different from case by case. We are afraid that the EMA, like the FDA approval can take a couple of years. We are not sure if EMA refers to the FDA results- since it is a completely different administration. From what we know, they would need to undergo various inspections and evaluations in verifying that it is fully approved as they may have different guidelines from the FDA.

          Regards,
          Luana
          HCell



  23. Augusto on February 2, 2018 at 7:06 pm

    En cuanto tiempo piensa que puede llegar este tratamiento a Argentina? Muchas gracias



    • Augusto on February 3, 2018 at 5:05 pm

      Sii, estamos en el horno! Ni siquiera nos contestan!! En unos años quizá se nos de!



      • Karl on February 6, 2018 at 11:48 am

        Dear Augusto and Seba,

        Please forgive us for the delayed response. We consider both Central and South America important international marketplace for HCell treatments. The timeline is still to be determined however, as it depends on our ability to find prospective investors/partners in Central and South America where we hope to have HCell treatments available soon.

        We’ll keep you updated on our Facebook (@HCellinc) and our Twitter (@HCellinc) pages.

        Karl
        COO
        HCell.net



  24. Yoda on February 3, 2018 at 6:57 pm

    Any particular reason why you censored my question about an FDA timeline? It wasn’t a “negative” comment as far as I could tell. I want to make sure I tow the line with your rules and regulations in the future.



    • Follicle Thought on February 4, 2018 at 3:09 pm

      Yoda, your comment was not removed, the comment you replied to was removed for a moment which made your reply invisible.

      No need to toe the line here my friend, Follicle Thought is very reasonable.



      • Yoda on February 5, 2018 at 5:19 pm

        Thanks Joseph, guess I got lost in the black magic of the internet…it’s good to be back! 🙂



  25. kj on February 4, 2018 at 12:47 am

    Everyone please check this amazing news:

    https://www.sciencedaily.com/releases/2018/02/180201142853.htm



  26. Akash on February 4, 2018 at 3:23 am

    Team,
    Let’s Keep USA trails aside for a while and introspect one important question, “Did the development of potential treatment fo AGA completed, or it’s still in research phase by HCell?”
    If it’s still in research then how long are you planning to continue development, to put an end to this problem.
    Thank you.



    • Karl on February 6, 2018 at 12:57 pm

      Hi Akash,

      Thank you for your interest! HCell has been treating patients in South Korea for approximately 4 years and we have approved patents (Composition and Methodology) in the U.S. and South Korea.

      We are currently endeavoring to advance our products through the U.S. FDA regulatory process to test for safety, efficacy and, ultimately, market approval.

      Please check our Facebook (@HCellinc) and our Twitter (@HCellinc) pages for updates.

      Karl
      COO
      HCell.net



  27. BenJ on February 4, 2018 at 2:37 pm

    Hi,

    To reach the European market without the requirement of EMA you may think of marketing the product to Turkey (histogen another biotech company was thinking of this), as many individuals particularly from UK travel there for hair transplants. They even have services where hotel/flights are included for Europeans, although you may need to do research on trustworthy surgeons.



    • Hairguy on February 4, 2018 at 3:28 pm

      Thank you for the reply Hcell. Those 3rd case study looks good. How long will fda trials take. I know most drug trials take roughly 8 to 10 years with phase 1 to 3. Your treatment isn’t drugs so would this take a much quicker approval process? Like a year or so since it’s already safe and working in south korea? If this will take typical trial length of 5 plus year I would rather go to south Korea and get this done to save my hair because I won’t have any if it’s going to take 5 years due to fda trials



    • Karl on February 6, 2018 at 1:14 pm

      Hi Ben,

      Thank you for your suggestion!

      For the european markets, our current focus is to follow the proper EMA regulatory protocol as well in time. However, we’ll keep an open mind.

      Karl
      COO
      HCell.net



  28. Kyros on February 4, 2018 at 6:04 pm

    Hi! This is incredible! I’m confused – isn’t this your “wildcard”? I feel like these results are more impressive than what glimpses we have of Histogen and Shiseido/Replicel Phase 2. Why aren’t we popping bottles and flying off to S Korea yet? Xx : )



    • Follicle Thought on February 5, 2018 at 11:42 am

      Gotta take everything a step at a time and review more results, respectively.



    • Karl on February 6, 2018 at 1:29 pm

      Hi Kyros,

      Thank you for your interest. HCell’s primary goal is long-term sustainability in nature in order to allow HCell treatments available/accessible to more people in more countries in time.

      Karl
      COO
      HCell.net



  29. Shiven on February 5, 2018 at 2:34 am

    When will this treatment will be avialable in India?



    • Karl on February 6, 2018 at 1:56 pm

      Hi Shiven,

      Thank you for your interest. Our ability to have HCell treatments available in India depends on the procurability of prospective investors/partners in India as well where we hope to have HCell treatments available.

      Karl
      COO
      HCell.net



  30. Matt on February 5, 2018 at 11:56 am

    All I can say is amazing! I will be following this one closely and checking plane ticket prices in the near future. The advancements being made by these new entrants is refreshing. Thanks Admin!



    • Follicle Thought on February 5, 2018 at 1:15 pm

      Good to hear from you Matt!



    • Karl on February 6, 2018 at 1:59 pm

      Hi Matt,

      We appreciate your kind words. Please follow our Facebook (@HCellinc) and our Twitter (@HCellinc) pages for updates.

      Karl
      COO
      HCell.net



  31. Yoda on February 5, 2018 at 5:22 pm

    Hello Karl or Luana, I’m re-posting a question that got lost and was never answered, please respond.
    I appreciate that Hcell is going thru the proper regulatory process to obtain USA/FDA approval for male pattern baldness. Where exactly is Hcell currently is the FDA process (e.g. pre-clinical, phase 1, 2 or 3) and when would you estimate completing the regulatory approval process and making the treatment commercially available in the USA? My apologies if you’ve stated a timeline before but I can’t recall seeing this outlined clearly.



    • Karl on February 6, 2018 at 12:42 pm

      Hi Yoda,

      Please forgive us for the delay responding to your questions and our apologies in advance for not being able to provide you the answers to your questions.

      The FDA process does take 5 to 7 years (in some cases longer); however, we hope to be able to speed-up the process where possible without compromising proper protocols, including but not limited to safety and efficacy.

      We appreciate your patience and understanding!

      Karl
      COO
      HCell.net



  32. Luana on February 5, 2018 at 6:11 pm

    Hello Seba,

    As Karl mentioned in a previous reply, our sole objective is to swiftly advance our products through the U.S. FDA regulatory process to test for safety, efficacy and, ultimately, market approval. However, we are so thankful for your enthusiasm and hope that you follow our Facebook (@HCellinc) and our Twitter page (@HCellinc) for the latest updates as we update regularly.

    Regards,
    Luana



  33. KB on February 7, 2018 at 5:59 am

    Ok so we are looking at 5 years before FDA approval in the US



    • Luana on February 7, 2018 at 3:26 pm

      Hello KB,

      Unfortunately at this time, we are unable to provide a concrete timeline for HCell’s FDA approval in the US since it is different case by case , meanwhile, our team is working diligently and hope you follow our Facebook (@HCellinc) and our Twitter (@HCellinc) pages as we update frequently.

      Luana
      HCell



  34. Monique on February 7, 2018 at 10:51 pm

    Kerastem has released results of their Phase II clinical trial in the US. They use adipose derived fat and PRP. They report a 17% increase in hair density. Do you have comments regarding the differences in your treatment and Kerastem.
    https://www.prnewswire.com/news-releases/kerastem-reports-successful-us-phase-ii-hair-growth-clinical-trial-results-300568170.html

    In regards to my statements in previous posts regarding FDA approval. There are clinics offering this exact treatment, PRP with autologous fat. You are just agreeing that the FDA has not stated it helps hair loss. Same was true for a long time regarding the many different laser hair therapy combs and caps, etc. They were marketed and sold long before the FDA basically came out and said that they were safe and might have some benefit. Just clarifying what I said earlier.



    • Follicle Thought on February 7, 2018 at 11:13 pm

      Monique, just wanted to help you out for a second here, and I’m sure HCell will provide you a full response. HCell does not use autologous fat in their therapy, they use bFGF.



      • Monique on February 8, 2018 at 11:25 am

        Yes, I’m fully aware. I’m in medicine and well versed in research and the topic at hand. My question asked their opinion of the differences, perhaps if they felt this growth factor is superior. I am also wondering if you have any info on this site regarding Kerastem. They released results recently. I have never seen anything here regarding Kerastem. Thank you



        • Luana on February 8, 2018 at 6:38 pm

          Monique,

          Thank you for your concern, and we are glad that you have been so keen on learning about HCell.

          Our Treatment’s main concern is the vascularity and thickness of scalp without stem cell treatment. We have seen positive results from our patients- officially, we have not reported to the FDA about the increase of density as of yet. It is great that another company is working hard to help alopecia patients, just like HCell.

          If you would like to know more about the scientific details of HCell, it would be great if you can directly reach me through the e-mail listed below- we would love to answer any more of your questions.

          Luana
          luana@hcell.net



  35. Trevor on February 8, 2018 at 5:56 pm

    First off, it is very frustrating to see so many people ask the same questions again and again, I strongly recommend that people READ all the comments and answers BEFORE asking questions. Why do people waste everybody’s time? More importantly, they totally waste the time of the HCell executives who are patiently responding to the same questions over and over.
    Get a grip people – you need to be more considerate and stop being lazy.

    Ok, here are my questions:
    1. Is the actual treatment essentially the same in its constituents (PRP/bFGF) for pediatric as well as AGA?
    2. If the answer to #1 is yes, then do you agree that getting the Orphan Drug designation from FDA for pediatric essentially means the treatment’s SAFETY is valid for pediatric AND AGA as well?
    3. You mentioned that there is no derivatives from pig urinary blader used in HCell’s treatments. While that is excellent news, is the PRP/nFGF treatment used by HCell for AGA include any foreign body matter or does it involve the patient’s very own cells? In other words, is it allogeneic or autologous?
    4. You mention 3 treatments spread 28 days apart. Does it have to be exactly 28 days apart? I am guessing so, since the 28 days is the “cycle” phase, correct? If so, people traveling to S. Korea have to hit those 3 appointments at exactly 28 days each, else, the whole trip becomes a waste. Correct? If the answer is yes, that means an incredibly difficult challenge to HCell’s scheduling team to get people lined up exactly for the 3 appointments, and also very challenging for patients too.

    Please do accept my sincere congratulations for your efforts. The photos of AGA are just amazing. If such great results can be achieved for a 57 year old male, that is really proving a lot. A big thank you to Hcell and also to Admin who keeps bringing to us these therapies.



    • Luana on February 8, 2018 at 8:11 pm

      Dear Trevor,

      Our team and I are happy to answer your questions!

      1. AGA patient’s treatment and the procedure schedule is different from Alopecia Areata for pediatric patients.
      3. HCell’s treatment is autologous.
      4. HCell is a separate enterprise from the clinic in South Korea. At the clinic, the full treatment (3 injections) do not have to be exactly 28 days apart, as long as the injections are 3-6 weeks apart (depending on the patient’s condition and schedule, as it is different case by case). For more information about the treatment in South Korea, the clinic’s team can be reached at replyinquiries@gmail.com

      We thank you for your excitement and enthusiasm! We are thankful to Joseph for this wonderful opportunity!

      Luana (luana@hcell.net)



      • Trevor on February 8, 2018 at 9:55 pm

        Hi Luana,
        Thank you for the quick response.



  36. Trevor on February 8, 2018 at 6:06 pm

    Sorry, correction. I meant a 65 year old male, not 57 year old. Very, very impressive growth for a male at that age! Thanks and look forward to hearing from the experts at HCell.



  37. Michael L on February 13, 2018 at 7:44 pm

    Great to see your results thusfar and your willingness to interact with the eager public.

    A few questions.

    Would this likely be effective on men and women suffering from diffuse thinning such as in cases with DPA or DUPA?

    Also, while this may be reaching for an answer thst may have too many variables to reasonably account for… is there any reason to think this would in any way be complicated by a person’s partaking in other AGA treatments such as Histogen’s HSC, Replicel’s RCH-01, or Rivertown’s potential treatments?

    Thank you for your dilligence and consideration.

    -Mike



  38. Luana on February 14, 2018 at 5:34 pm

    Hi Mike,

    Thank you for your question! We’ve had affirmative results on patients suffering from diffuse thinning such as DPA and DUPA. When we tested HCell with AGA treatment such as Minoxidil, our patients had unpredictable results. (Dr. Lim has answered a question similar to this one above, asked by Dr. Amnon Gonenne, where he provides more detail about this outcome)

    Thanks,
    Luana (luana@hcell.net)



  39. Clive on February 15, 2018 at 5:21 pm

    Hi

    Wow all looks and sounds great, congratulation!

    Just a few questions, which I don’t think has been asked and may be due to my lack of knowledge!

    1. Does the HCell treatment that is available in Korea treat Male Pattern Baldness?
    2. If not does the HC0100 target Male Pattern Baldness, if so is this available in Korea/

    Thank you very much

    Clive



    • Karl on February 16, 2018 at 12:33 pm

      Hi Clive,

      Thank you for your question, and that’s no problem at all.

      Yes, HCell treatments currently being performed at a clinic in South Korea have shown positive hair growth across all subjects, including but not limited to male pattern baldness.

      Karl
      COO
      HCell.net



  40. Luis Hernandez on February 16, 2018 at 1:10 pm

    Is this available in SK only? If yes how can I make an appointment to go there I live in USA



  41. D on March 16, 2018 at 4:55 am

    Hi,

    Would you recommend this treatment for 3yo with AA?
    How many AA patients in SK have you treated? How’s their response?

    Thanks



    • Follicle Thought on March 16, 2018 at 10:16 am

      Please contact the Clear Clinic directly. Best wishes



  42. Mohammed arif on April 16, 2018 at 12:42 am

    When ths treatment will avaliable in india!!?



  43. Waldo Pepper on December 12, 2018 at 3:56 pm

    Any news on availability in the US and/or internationally?



Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.