Histogen Update from Ziering Medical

[doke]

Watch out bro, he will put you on his ignore list if you point out his whiny female tendencies, like he did me. I have been devastated ever since...

He did same to me he picks and chooses who he wants to respond to he really needs to grow up.

[deuce]

Where the hell is Follica. They get out hopes up every two years with some announcement and we never see anything from it. First it was pdg2 and then Fgf9. Cotsarelis said three years ago that we would have something available. Then we here from the pricks two years later about something else.

[ryan555]

why exactly is anyone wasting time with histogen at this point? when their rep up and tells you they're a few years away and suggests another treatment that's a pretty good sign to move on for now.

Whoever wrote that is not a rep for Histogen. They are not associated with Histogen in any way except that they work for a doctor who performed a small study with their product.

[Conpecia]

why exactly is anyone wasting time with histogen at this point? when their rep up and tells you they're a few years away and suggests another treatment that's a pretty good sign to move on for now.

[greatjob!]

Don't you dare mock Hellouser. Hellouser is slowly venting his way into a cure i'll tell ya. All these worthless biotechs are incompetent! I bet Hellouser is working multiple experiments in his basement as we speak and will personally bring us a cure within 2 years. He has done so much for us!

Watch out bro, he will put you on his ignore list if you point out his whiny female tendencies, like he did me. I have been devastated ever since...

[locke999]

Yes cry about it some more, that will help

Don't you dare mock Hellouser. Hellouser is slowly venting his way into a cure i'll tell ya. All these worthless biotechs are incompetent! I bet Hellouser is working multiple experiments in his basement as we speak and will personally bring us a cure within 2 years. He has done so much for us!

[greatjob!]

Yeah, the market with men that suffer with AGA is too large to focus on... lol. My god, the priorities of some of these biotechs.

Yes cry about it some more, that will help

[hellouser]

they did had impressive results... with females

I guess the market of females with severe AGA is pretty small

Yeah, the market with men that suffer with AGA is too large to focus on... lol. My god, the priorities of some of these biotechs.

[bigentries]

It was a bad sign when Histogen used two different areas for one of the macro before and after photos. The other one was completely misrepresented as well, with the wild numbers they were throwing around. And yes, there is zero doubt that this happened.

That's basically the day when I lost any and all faith in Histogen. They really haven't shown anything at all to get excited about.

they did had impressive results... with females

I guess the market of females with severe AGA is pretty small

[JJJJrS]

It was a bad sign when Histogen used two different areas for one of the macro before and after photos. The other one was completely misrepresented as well, with the wild numbers they were throwing around. And yes, there is zero doubt that this happened.

That's basically the day when I lost any and all faith in Histogen. They really haven't shown anything at all to get excited about.

[rhysmorgan]

First post here, but I've been lurking since 2007, 2008...something like that.

I just came on to say that the criticism of the FDA process as a whole (of course, component parts of any process should be constructively criticised) is a very silly thing to do in the context of stem cell research. Stem cell research can involve some extremely dangerous elements. a friend of mine is the editor of the stem cell section of one of the biggest A* scientific journals and they said that this stuff is incredibly dangerous, and treatments should never be considered in deregulated/non-regulated environments.

The 3 phase process/similar processes (e.g. UK) is necessary for this type of research to ensure safety.

[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.

[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.

[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..

[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