Han Bio Planning Hair Multiplication Trial This Year

pegasus2

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During an interview with The Korea Herald on Friday last week, Kang said with this technology it would take just a single strand of a patient’s hair to cultivate enough cells to reproduce around 30,000 hair strands.
Using the new technology, Han Bio could also reduce the cost of hair transplantation. “The company expects to be able to cut the cost since the amount of time required for hair transplantation by using our technologies is around half of existing hair transplantation surgeries,” he said.
The company plans to start its clinical studies in the second half of this year, after submitting the necessary documents to the authorities.
Kang said he expected the time required for clinical trials to be shortened under a new law here
They make bold claims. I'm not familiar with this company, and I don't know how their technology works. The article only mentions injecting DP cell clusters. I don't know how they make them form a new hair, or if they have even confirmed it in human skin grafts. I hope they can really do what they claim, but I'm skeptical. It sounds more like they are going to get Replicel tier results rather than 30,000 new hairs.


 

SaveTheMane

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It better be true because back in 2016 to 2018 the news are saying they will start trials in 2020.
 

eeyore

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Nice find, one other potential company to keep us hopeful. Best case they cure hair loss in a few years, worst case they pull a Jon Knight, but we have nothing to lose. Looks like they're trying to create an all in one solution with their storage plant as well.
 

eeyore

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A company is bound to get there eventually, and the more in the race the better. Even J Hewitt should at least be a very miniscule threat to Stemson, encouraging them to not sit around.
 

rapper dude

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They make bold claims. I'm not familiar with this company, and I don't know how their technology works. The article only mentions injecting DP cell clusters. I don't know how they make them form a new hair, or if they have even confirmed it in human skin grafts. I hope they can really do what they claim, but I'm skeptical. It sounds more like they are going to get Replicel tier results rather than 30,000 new hairs.


Nice catch, we need this and everyone will be happy if it works. How much would this cost?
 

eeyore

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"Han Bio has already finished construction of its first plant, where the company stores and cultivates patients’ dermal papilla cells. Whenever a patient wants, the company can regroup 3,000 cultivated dermal papilla cells and transplant them into the recipient.

The facility is currently undergoing a validation process and expects to start operation in April or May, Kang added."

Looks like they've already invested quite a bit into this, which I would take to mean they're not just lying like Jon Knight.
 

pegasus2

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It looks like with the new law we are looking at 3 years at the earliest after they begin trials. I doubt this will qualify for early launch.

it will allow the authorization process to begin earlier, with drugmakers able to submit data for screening before the drug is completely developed. Second, biopharmaceuticals for rare and obstinate diseases can get screening priority. Finally, some treatments for cancers and rare diseases would be eligible for marketing approval based on phase II data, under the condition that the drug must prove its effectiveness and will be launched after carrying out phase III.
Generally, new drug R&D in South Korea takes 12 to 15 years. The new act is expected to shorten that process to between three to four and a half years.
Based on the new act, stem cell therapy will be available under limited conditions. The therapy must be carried out for clinical research and on patients with cancers and obstinate diseases. The government will designate the medical institutes permitted to use stem cell therapy after strict screening and authorization. To prevent recruiting patients for profit, the medical institutes will not be able to charge the patients. Instead, the government will support the entire cost of the clinical research.
"For the stem cell therapy developers in Korea, the fast track supporting law will accelerate marketing their products and treating patients with rare and obstinate diseases. In particular, the companies carrying out clinical trial phase II or III will be able to launch their products early," a spokesman at the Korea Biomedicine Industry Association told BioWorld.
 

eeyore

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It looks like with the new law we are looking at 3 years at the earliest after they begin trials. I doubt this will qualify for early launch.



It doesn't qualify according to those criteria, but the CEO believes it will, and it seems unlikely he'd just make a statement like that if it were so clear cut untrue.
 

pegasus2

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It doesn't qualify according to those criteria, but the CEO believes it will, and it seems unlikely he'd just make a statement like that if it were so clear cut untrue.
Let's hope their drug administration commissioners are bald. It's not clear what Kang meant by that. He may simply have meant that it would be 4.5 years instead what it used to be.

image_readmed_2020_849881_15977400164321880.jpg
 

trialAcc

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It looks like with the new law we are looking at 3 years at the earliest after they begin trials. I doubt this will qualify for early launch.



I think you're reading this slightly wrong, the 10-12 year process includes pre-clinical research, which this company has completed. This could be different but phase one studies are usually 12-24 weeks and phase 2 studies are anywhere between 6 months and 2-3 years.

Edit* I see your chart on the reply. That's what I mean, they have phase 1-3 in 4~ years which would leave around 18 months for phase 3 and data aggregation. Phase 1-2 can easily be done in 2 years.
 

pegasus2

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I think you're reading this slightly wrong, the 10-12 year process includes pre-clinical research, which this company has completed. This could be different but phase one studies are usually 12-24 weeks and phase 2 studies are anywhere between 6 months and 2-3 years.

Edit* I see your chart on the reply. That's what I mean, they have phase 1-3 in 4~ years which would leave around 18 months for phase 3 and data aggregation. Phase 1-2 can easily be done in 2 years.
Right. This will likely require 3 completed trials before they can launch it as it doesn't seem to meet the criteria for an early launch, so 3 years if we're lucky.
 

trialAcc

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Right. This will likely require 3 completed trials before they can launch it as it doesn't seem to meet the criteria for an early launch, so 3 years if we're lucky.
Isn't this basically the same process that Stemson is going through, except that here they are specifically cultivating the DP cells? Either way, extremely promising to see multiple companies pursuing these types of treatments pathways.

Also adds credence to the pricing model Stemson will use as well, if these guys are looking to drive prices down based on actual labor I'm sure Stemson will have to go a similar route.
 
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pegasus2

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Isn't this basically the same process that Stemson is going through, except that here they are specifically cultivating the DP cells? Either way, extremely promising to see multiple companies pursuing these types of treatments pathways.

It sounds like it since they compare it to a hair transplant and say that this procedure will take half as long. If they are just culturing DP cells and injecting them like Replicel then it shouldn't take even that long to do the procedure. However, all they mention is DP cells which wouldn't form new hairs by themselves. Stemson is also using keratinocytes and including the different cell types in a scaffold to approximate the layers of the hair matrix over the DP. The size of the hair shaft is determined by the size of the DP, but the Matrix is what produces the hair shaft. If all you do is implant DP cells then where is the hair shaft going to come from? All Replicel's DP injections do migrate to an existing DP to enlarge it so that the keratinocytes begin producing thicker and longer hair shafts again. The efficacy of that seems to be limited, and it certainly doesn't produce new hairs like Stemson does. Considering the cost of Stemson's procedure and the fact that they only mentioned DP cells, I'm leaning towards their procedure being more like Replicel's than Stemson's.
 
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