Update: November 17, 2020
See the bottom half of this post for more details on Smart Hair Transplants (SHT) and J.Hewitt.
The TissUse team published two interesting new studies in 2020. The first from April was related to hair growth in reconstructed human skin. The second just came out this month and discusses the microfollicle as a model of the human hair follicle.
TissUse Responses Regarding J.Hewitt
More relevant, reader “PaulR” corresponded with TissUse several weeks ago and below are their responses.
Hello,
I have been interested in TissUse’s new hair cloning technology for the past few years. I am aware that J.Hewitt has a license to test this technology in Japan. I have e-mailed this company, but have not received any reply. I have a few questions about the process of this new technology.
Question 1) Are the pre-clinical tests complete for this technology? I have not read about any animal tests. Does this mean that such tests need to be completed before human trials can commence?
Answer 1) Animal tests have not been performed so far. However, animal tests are not required in Japan to initiate first in man trials if one can show solid in vitro data proofing safety of the method. Japan is unique here as other countries or regions like the US or Europe would require animal tests.
Question 2) I read online that J.Hewitt had planned on conducting a clinical trial last year. But this doesn’t seem to have happened as they cannot find a cell processing company. Do you have any information about when human trials will start? Can we expect this to happen in 2021, or are we a few more years away from trials?
Answer 2) The COVID-19 pandemic severely impacted the timeline of J.Hewitt. They are now continuing to look for a GMP manufacturing unit with the required capabilities to produce the transplants. If this is successful we believe first trials can start in 2021.
Question 3) TissUse is obviously a very innovative company. Are you confident this technology can change the ways current hair transplants are conducted? Does your company see this being available to clients in Japan in the next few years, or is it 5-10 years away?
Answer 3) Japan takes a unique approach to these new cell-based therapies and is actively promoting their development. It is therefore possible that the technology can be available in Japan in the next couple of years should the clinical trials be successful. The outcome of the first clinical trial will very much define the timeline for a potential market launch.
GMP Manufacturers
Also of note, two months ago, I contacted TissUse too and got the below reply:
“J.Hewitt is in discussion with a couple of GMP manufacturers for the SHT technology. We expect to hear of the outcome of these talks soon. Apparently it is still difficult to find a manufacturer due to the ongoing Corona crisis but J.Hewitt definitely made some progress here.”
Best regards,
The TissUse Team
April 22, 2019
TissUse and J.Hewitt Partnership
Earlier this month, Germany’s TissUse entered into an agreement with Japan’s J.Hewitt that may have significant implications for hair loss sufferers. This agreement is in regards to the licensing and further development of the former’s Smart Hair Transplant (SHT) technology in Japan.
Fuji Maru from Japan first noticed this development and has covered it in detail here. He has been in contact with the company’s CEO Jon Knight.
TissUse also has a press release page where you can find the story towards the top for the time being.
Among the main scientists who developed TissUse’s technology is the well known Dr. Roland Lauster. He is now on the company’s advisory board. In the past, Dr. Gerd Lindner also used to be on that list.
As has been mentioned numerous times by myself and many others over the past several years, Japan’s government is heavily promoting regenerative medicine in the rapidly aging country. One of the main ways it is doing so is via speeding up the usually lengthy and expensive clinical trial process (which is common in most developed countries).
Smart Hair Transplants
In the case of SHT, the process is autologous in nature. So clinical trials are possibly not required, or will be fairly short in duration if required.
Smart hair transplants theoretically provide unlimited donor hair. By isolating cells from the dermal papilla and then culturing and multiplying them, this procedure supposedly forms neopapillae. According to TissUse:
“Neopapillae are the precursors of hair follicles which have been shown to grow hair follicles under controlled conditions in vitro. Each of these neopapilla has the potential to form a brand new hair follicle.”