Histogen Update from Ziering Medical

[locke999]

You don't think rationally, do you?

Alright fine, you get a good part of your hair back. Then what? You continue to to go bald, and the other areas continue to thin out and eventually turn slick bald. That single and very costly hair transplant doesn't do jack shit. Some guys don't even respond to Finasteride.

But hey, looks like your method is 'good enough' for everyone! Let's all throw our hands in the air with praise because you've figured out a way to do a hack job treatment for hair loss using archaic methods!

My god.

What do you want us to do. Whine and complain with you on this forum at every chance we get like you do? How does this help at all? If you put as much effort as you do in complaining on these forums into actually getting into a lab and finding a cure, maybe you might just beat all these researchers who you insult so much to the cure.

I'll patiently wait okay?

[robodoc]

You still have your frame do you? Wait until you turn slick, come back here and tell me the change is not dramatic.

Fill up the third front can completely change a person's look. Of course you don't know that because you're still a NW3.

Yea, that frame can help SOME people but HT is not for everyone like the hair docs like to imply. Take the pro basketball coach who looked ridiculous with his HT. He had the grafts removed.

[Scientalk56]

I spoke to Histogen. HSC is NOT shelved and they are moving forward.
Now everyone relax.

Yeah but my hair is not going to relax...He is moving forward too and shedding. When i get to norwood 7 Histogen won't be relevant.

Histogen for me is dead...

[UK Boy]

[QUhbale;164551]Did they tell you this directly?

Don't mean to put a downer on it but that means nothing. A rep from Aderans informed a poster on here that Ji-Gami was continuing as normal even after it had been discovered is was being discontinued.[/QUOTE]

I haven't been on the website for weeks due to there being nothing worthwhile to read for quite sometime prior. I saw this thread and upon reading the msg from Ziering I immediately made the conclusion that Ryan555 has confirmed - Ziering are referring to their own physician sponsored trials. I know this because I contacted them last year to find out if they would be doing more and their response was the same.THEY are not intending to carry out any more trials and take the opportunity to try an push shitty prp/acell. They DO NOT state that HISTOGEN have no further trials planned! Ziering DOES NOT = HISTOGEN! Why do people get confused by this?! And then spread false info and start claiming the end of the world. The post also stated approval takes 5-7 years, as others already said that referes to the general approval timelines not saying they will take another 5-7 years. The thing to take from this post is GOOD news, Histogen's treatment has effect for longer than 2 years! I am worried about Histogens results as two well respected hair transplant docs (Cole & Hassan) have said they are not impressed with presentations but I still will try it when it becomes available even if just to maintain.

Hellouser does make some good contributions (RU guide and involvement in demerolling thread) but he also gets carried away on certain topics and I think he needs to spend more time away from this site for his own sake.

[Dav7]

Wasn't this stuff always proposed for release on the Asian market for 2014/15 or 2016 at the earliest? And perhaps it just might be still? As for the US, to hell with that, we'll probably have transport vehicles capable of intergalactic travel before the FDA crowd ever give the thumbs up to such a treatment for MPB

[HairBane]

Wasn't this stuff always proposed for release on the Asian market for 2014/15 or 2016 at the earliest? And perhaps it just might be still? As for the US, to hell with that, we'll probably have transport vehicles capable of intergalactic travel before the FDA crowd ever give the thumbs up to such a treatment for MPB

late 2015 - early 2016 still seems feasible IMO, but they would have to begin their final phase 2 trials within the next few months and start doing whatever negotiating/paperwork needs to be done to secure a pan-Asian release on completion of phase IIb right now. Let's hope they know what they're doing and have enough funding to pull it off. I'm sure they have an ambitious plan.

Yeah, Elon Musk thinks we'll have the technology to ship millions of people to Mars and millions of tons of cargo there in about 10-12 years. It would be sort of embarrassing if I end up moving to mars, but have a bald scalp because the FDA delayed all the stem cell therapies for years. Maybe that's what happened to Picard - he was just waiting for the FDA to approve hair multiplication.

[hellouser]

Yeah, Elon Musk thinks we'll have the technology to ship millions of people to Mars and millions of tons of cargo there in about 10-12 years. It would be sort of embarrassing if I end up moving to mars, but have a bald scalp because the FDA delayed all the stem cell therapies for years. Maybe that's what happened to Picard - he was just waiting for the FDA to approve hair multiplication.

Like I said elsewhere, no biotech should be doing any of their clinical trials in USA. FDA is a joke and will only SCREW the biotech's plans.

Anyone know WHY the FDA is so ass backwards?

[James7]

It would be sort of embarrassing if I end up moving to mars, but have a bald scalp because the FDA delayed all the stem cell therapies for years. Maybe that's what happened to Picard - he was just waiting for the FDA to approve hair multiplication.

Haha good one

[bigentries]

I keep reading the FDA blaming

Has a researcher came out and proclaimed that FDA is the reason Aderans, Intercytex or any other potential baldness treatment failed?

What is the other option? Besides going fully unethical with human experimentation

This is sounding like those weird conspiracy theories about the electric car, where no single serious researcher was involved

[HairBane]

I keep reading the FDA blaming

Has a researcher came out and proclaimed that FDA is the reason Aderans, Intercytex or any other potential baldness treatment failed?

What is the other option? Besides going fully unethical with human experimentation

This is sounding like those weird conspiracy theories about the electric car, where no single serious researcher was involved

Well the whole slow/expensive clinical trials/FDA approval process could be directly or indirectly assigned blame to the failure of those companies, whichever way you look at it. If it was much cheaper and faster, they could all have had a product on the market within a few years and been turning a profit.

I posted a thing a while ago about a company that is trying to disrupt the clinical trial process, massively reducing both cost and time.

http://www.xconomy.com/boston/2013/04/16/re-thinking-clinical-trials-for-the-world-of-crowdsourcing/

Transparency Life Sciences (TLS) is a drug development company and a leader in the effort to embrace open innovation in clinical development. Tomasz Sablinski, the company’s CEO and founder, is calling for transparency in clinical trials to improve study design, quality and outcomes while drastically reducing costs. With recent clearance by the FDA of its Investigational New Drug application to assess lisinopril as an adjunct treatment for multiple sclerosis, TLS is embracing the power of disruption. Sablinski’s goals are universal and his success would be revolutionary. TLS aims to cut clinical development costs by 50 percent initially, with an ultimate goal of 80 percent savings, along with designing better trials and producing better outcomes. That’s high-impact, groundbreaking change."

All the FDA needs to do is take a look at their system of doing things, and intelligently re-evaluate it for the 21st century. They could save millions of lives, cure thousands of different conditions, create a biotech spring.

I hear Japan is working on legislation to do something similar with it's trial and approval process. Asia as a whole is much more accepting of new therapies, which is why you don't need to do a phase III trial to sell there. The FDA is a bit of a dragon holding up the development and innovation of new treatments in the USA, and I hope they take a serious look at themselves and follow Asia's example.

[bigentries]

Well the whole slow/expensive clinical trials/FDA approval process could be directly or indirectly assigned blame to the failure of those companies, whichever way you look at it. If it was much cheaper and faster, they could all have had a product on the market within a few years and been turning a profit.

I posted a thing a while ago about a company that is trying to disrupt the clinical trial process, massively reducing both cost and time.

http://www.xconomy.com/boston/2013/04/16/re-thinking-clinical-trials-for-the-world-of-crowdsourcing/

All the FDA needs to do is take a look at their system of doing things, and intelligently re-evaluate it for the 21st century. They could save millions of lives, cure thousands of different conditions, create a biotech spring.

I hear Japan is working on legislation to do something similar with it's trial and approval process. Asia as a whole is much more accepting of new therapies, which is why you don't need to do a phase III trial to sell there. The FDA is a bit of a dragon holding up the development and innovation of new treatments in the USA, and I hope they take a serious look at themselves and follow Asia's example.

Again, not defending the FDA, since it has been proven to be corrupt, and definitely needs some reform, also, a lot of the blame is due to the nature of research funding in the US, we incentivize research, not invention

However, I think that people are vastly overrating the blame of the FDA, if places like Cuba, China, India, etc. that have way more lax laws on research haven't advanced hair loss treatments, it's probably because the current knowledge about hair loss is very limited, and not because bureaucracy is stopping things

I see people complaining about the way trials are done in the FDA, but never point out what is exactly wrong and who is doing it better and how, from that I can only read it as people proposing completely unethical trialing of drugs and procedures

[Kiwi]

All of this talk about a totally retarded FDA reminds me of a totally retarded system that makes other drug laws. This is a brilliant read albeit a little off topic.

http://www.theguardian.com/commentisfree/2014/feb/06/russell-brand-philip-seymour-hoffman-drug-laws

[Scientalk56]

Again, not defending the FDA, since it has been proven to be corrupt, and definitely needs some reform, also, a lot of the blame is due to the nature of research funding in the US, we incentivize research, not invention

However, I think that people are vastly overrating the blame of the FDA, if places like Cuba, China, India, etc. that have way more lax laws on research haven't advanced hair loss treatments, it's probably because the current knowledge about hair loss is very limited, and not because bureaucracy is stopping things

I see people complaining about the way trials are done in the FDA, but never point out what is exactly wrong and who is doing it better and how, from that I can only read it as people proposing completely unethical trialing of drugs and procedures

+1
Agree...

It's not like someone has found the cure, and the FDA is not letting him

Many people use snake oil shit on their heads, but still didn't hear of someone who was cured by it (or even got any positive results)

Histogen for example was supposed to release its product in Asia after phase 2b... and here we are in 2014, still stuck with minoxi and propecia..

So lets not blame he FDA on this..

[k3nk3n]

Has anyone been able to get in touch with Histogen or Gail for any new updates? They are usually good with updating us, however, I havn't been able to get a hold of them for a couple of months now. Last I heard from Gail was back in August, where she told me they were planning physician sponsor trails in Korea and Taiwan.

[Desmond84]

Came across this little gem in the Principles of Tissue Engineering 4th Edition by Dr Lanza, Langer & Vacanti, which was published literally a few weeks ago. This 2000 pages of tissue engineering gospel is seen as the blueprint for those in regenerative medicine! Funly enough, one of the chapters covers all of our concerns and discussion regarding the slow progress of regenerative medicine and provides us with some indication of a light at the end of the tunnel. Please read this in full as I didn't have an electronic version and had to type the whole thing lol

OUR CURRENT STATE OF CLINICAL APPLICATIONS

The overall impact of tissue engineering in biomedical science has been fairy diverse in nature. Directly and indirectly, it has enhanced our understanding of the structure-function relationships within normal and pathological tissues. It has also broadened the possibilities for testing pharmacological therapies.

Still, the ultimate benchmark for the success of tissue engineering, as a multidisciplinary field, remains its ability to generate new and more effective therapies for patients afflicted with severe tissue loss and/or organ failure. Based on this measure, only a handful of tissue-engineered products have reached the bedside. By and large, thus far these clinically tried tissue-engineering therapies have demonstrated mostly adequate safety, with only modest, if any, therapeutic benefits in small, defined patient populations, or even simply through anecdotal data. Therefore, it is safe to say that tissue engineering has yet to fulfill its promise for the vast majority of patients in need.

1) HIGH COST
One practical barrier has been the high cost of these technologies. Because elaborate and expensive infrastructure are often necessary for the development and manufacture of engineered tissues, products designed to address relatively rare disease processes are often difficult to remain sustainable in the long term. Indeed, many firms with considerable interest in tissue engineering and regenerative medicine have exited the market despite early studies suggesting efficacy.

Production with Good Manufacturing Practice (GMP) facilities are a prerequisite for FDA approval of cell-based therapies, which, in turn, cannot be pursued without a critical mass of highly trained personnel. Furthermore, certain tissues require preconditioning in complex bio-reactors, which may not be readily amendable to scaled up manufacturing and shipping. All of these issues translate into a chronic difficulty in establishing multicentric clinical trials, which are in turn essential for widespread application of new therapeutic strategies.

2) REGULATORY MATTERS
Despite the common goal of introducing safe tissue engineered products within the clinical arena, most have perceived the regulatory constraints imposed on the field to constitute a significant barrier towards clinical translation.

In USA for example, the FDA has a long history of being notoriously slow at initiating and conducting product approval processes in tissue engineering. This problem has been attributed, at least in part, to the lack of clear regulatory frameworks and occasionally to uncertainties regarding whether tissue engineered products should be classified as mechanical implants, biological materials, or both.

Furthermore, unlike many other biotechnology developments, cell-based tissue engineering technologies are rather unique in that they need to be thoroughly tested for infectious pathogens., tumorigenic potential, and immune reactions (the latter even in autologous applications, stemming from cell processing and/or scaffold composition).

Engineered tissues also need to be rigorously studied in animals prior to clinical application. Depending on the particular product, such testing may require costly large animal models as a means to provide final proof of principle and safety to the FDA prior to implantation in humans.

For many companies devoted exclusively to tissue-engineering technologies, such regulatory burdens and delays, combined with strict reimbursement policies and intermittently poor business models, have often conspired to a commercially untenable enterprise.

A few American biotechnology companies have been able to seek different tactics by accumulating clinical data overseas at a lower cost, given that many other countries have far less stringent regulatory procedures with regard to marketing and clinical application of novel medical products than those endorsed in USA. Recently, this has been evidenced by several US regenerative medicine firms initiating their pilot tissue-engineering clinical trials in countries such as mexico, Argentina, Korea, and Poland.

3) SCIENTIFIC LIMITATIONS
The rapidly changing technologies within the broad, multidisciplinary field of tissue engineering have sometimes made clinical evaluations fairly difficult. For example, the ideal cell type or even cell source for many clinical applications remain undermined. In many cases, while while differentiated autologous cells would be ideal, their use simply may not be a viable option in humans, either because of current isolation and expansion limitations (e.g. Dermal papillae cells) or because they tend to dedifferentiate over time (e.g. chondrocytes).

Human embryonic stem cells (hES) and induced pluripotent stem cells (iPS) are relatively new and potent alternative sources for tissue engineering, but also carry potential tumorigenic behaviour, peculiar immunologic limitatiosn or have remained hampered by social and ethical constraints, particularly in the case of embryonic stem cells. Even autologous (your own) cells in culture may not be completely free of pathogens, since the culture media often requires xenogenic growth factors such as fetal bovine serum, for optimal growth, or because certain cells can only propagate consistently on murine feeder layers. [B] At this time, infectious risk cannot be completely eliminated with these xenogeneic techniques.

Another scientific limitation is the lack of an optimal biomaterial for many clinical tissue-engineering applications. Many of the currently available synthetic scaffolds are still metabolised by the body leaving a significant foreign-body reaction behind. These conditions can lead to a reduction in the diffusion of nutrients and waste products, fibrosis and other complications. Additionally, the cytotoxic effects of macrophage-generated nitric oxide can reach and destroy transplanted cells. Thus, it is not surprising that most of the scaffolds that have been implanted to date in humans are derived from natural scores (e.g. bone, dermis, interstinal mucosa). Unfortunately, at the same time, natural scaffolds have been associated with unfavourable mechanical properties (e.g. rapid or incosistent degradation, low or erratic tensile strength). Further, some chemicals used in the decellularisation process are known to negatively affect the properties of scaffold.

For these reasons, there remains a continued interest in the development of novel biocompatible synthetic biomaterials amongst materials scientists and others. For example, electrospinning is a somewhat novel, alternative approach for creating scaffolds that can be made with finely tuned biomechanical specifications. The advantages of this technique include, the ability to make scaffolds with high porosity as well as high surface area to volume ratio, while mimicking the dimensions and structures of native collagen and elastin fibrils.

Finally, scaffolds impregnated with growth factors or specific peptide sequences may also allow for better control of the surrounding microenvironment. Indeed, these newer synthetic biomaterials, will be instrumental in helping to broaden the types of engineered tissues that can be rendered viable in humans.