I am waiting for Histogen\'s final results

Stem cell; cell based hair therapy
61

» I think regenica for skin is the same regenica hair!
» What do you think?
» Regenica for skin is at the marked!!!
» Can we use it?
» In europe too?

I have no idea, sorry. If I see results in the hair version maybe I will investigate if we can get the skin version and use it for hair.

62

In this PDF:
http://www.histogeninc.com/downloads/stem_cell_summit.pdf

it is mentioned something about dermabrasion and Laser as the “Perturbation” methods.

» Dr. Naughton has replied to me, approx. 3 hours after I emailed her!!
» The reply was a provisional one, until she gets official answers to all
» the questions.
» I think I can post this first reply, as it doesn’t seem to contain any
» compromising info, and Eileen didn’t specify any objection.
»
»
» REPLY:
» **********************************************************************
» Hi! On your first question, subject scalps were divided into 4 treatment
» areas, each area receiving a single injection of HSC at the baseline
» timepoint.
»
» I will have to get back to you with official responses to your other
» questions a bit later, but I did want to follow-up to let you know that
» your inquiry was received.
»
» Thank you, and I look forward to providing further information soon.
»
» Eileen
» **********************************************************************
»
»
» My comment (SD comment):
» Regarding the subject of single injection:
» As Dr. Naughton says, the scalp was divided in 4 test areas, and each one
» received a single injection. I have uploaded a image contained in an
» Histogen PDF:
» contained
»
» I think this image shows clearly that the scope of action of a single
» injection is limited to a diameter of a few centimeters. And thus, I think,
» a whole bald scalp would require a dozen or more injections.
» Not a big deal, of course. Just compare with cell therapy (ICX, ARI),
» where you neeed thousands of injections (one per hair).
» Also, I assume that the HSC (Regenica) injections are less stringent in
» regards of precise depth of injection as it is required in cell therapy.
»
»
» » » Title of my mail:
» » » “Its SpanishDude from Hairsite. Questions about HSC-Regenica
» results.”
» » »
» » » Body of my mail:
» » » Hello Dr. Naughton:
» » »
» » » I am SpanishDude at Hairsite forums.
» » » I have read the information derived from the ISHRS meting last
» » Saturday,
» » » about HSC (ie. Regenica).
» » » I have 3 questions for you. if you were so kind to help me clarify
» » these
» » » things…:
» » »
» » » 1. Is it true that Regenica is just a single injection in the whole
» » scalp?
» » » And this injection is not repeated along the 5-month trial? I am so
» » amazed
» » » about this,
» » » that I need to confirm.
» » »
» » » 2a.Histogen’s website says that “perturbation” did not enhance the
» » results
» » » seen with HSC. Does that mean that none of the 3 perturbation methods
» » used
» » » in
» » » conjunction with Regenica showed any benefit? In other words, the
» » » injection is the only thing that works?
» » » 2b. Basically, what are these perturbation methods? Dermabrasion?
» » »
» » » 3. We were hoping to see data at the 22-weeks timepoint, but
» » apparently,
» » » Dr. Ziering only showed data at 12 weeks at the ISHRS. This data was
» » » already available months ago,
» » » so no new data was revealed. Can you tell us something about the data
» » at
» » » 22 weeks?
» » »
» » » This is all for now.
» » » I am posting at Hairsite HM forum, so its possible that I post about
» » your
» » » reply in this forum. If you don’t want me to post something about
» your
» » » reply, please specify so.
» » »
» » » Thank you.
» » » Best regards
» » » Spanish Dude
» » »
» » »
» » »
» » » » Thanks Rev.
» » » » As others have posted, the 12 weeks data is old data. I am going to
» » » email
» » » » Naughton asking for the 22 weeks data.
» » » » The article says that none of the 3 perturbation methods made any
» » » benefit.
» » » » I assume these are dermabrasion stuff???
» » » »
» » » » Still, it is wonderful that a single injection in five months
» brings
» » » any
» » » » benefit to all the scalp. I would like to confirm this. Is it
» really
» » a
» » » » single injection in 5 months? If this is the case, this would mean
» » HUGE
» » » » SAVINGS in terms of time and money. If they can fine-tune the
» » » formulation
» » » » and increase the results, this will be the real holy grail in
» this
» » » » field.
» » » »
» » » »
» » » »
» » » » » » » I feel they have nothing big to post. otherwise they would
» have
» » » » » updated
» » » » » » » their website by now. I hope I am wrong.
» » » » » » » anyway, give me Naughton’s email. I think it was posted here
» » » » » » previously.
» » » » » » »
» » » » » » » take a breather? it is funny. a forum that is full of idiotic
» » » » posts,
» » » » » » and
» » » » » » » now that there is something worthy to watch, people seem
» » » » » » » unresponsive/apathic.
» » » » » »
» » » » »
» » » » » Here’s the first article.
» » » » »
» » http://www.prweb.com/releases/Histogen/HairRegrowth/prweb2679084.htm
» »
» » GOOD JOB, I have other questions too but let’s see if she responds to
» this
» » one first.

63

» If they’re talking about doing a full 3-stage FDA trial before it gets to
» market, then it’s more like 10 years off than 5 years. That’s how long the
» trials really take no matter what anyone says to the contrary. This isn’t
» pessimism, it’s fact.

Trails take 2 - 10+ years for phase I, II, and III. 10+ is not the average it is generally an extreme.

64

» » If they’re talking about doing a full 3-stage FDA trial before it gets
» to
» » market, then it’s more like 10 years off than 5 years. That’s how long
» the
» » trials really take no matter what anyone says to the contrary. This
» isn’t
» » pessimism, it’s fact.
»
» Trails take 2 - 10+ years for phase I, II, and III. 10+ is not the
» average it is generally an extreme.

If what Histogen is doing is just an injection, then it shouldn’t take that many years for FDA to approve unlike real cell culturing that Intercytex and Aderans are attempting to do.

65

Are there news about the exit on the market?

66

» If what Histogen is doing is just an injection, then it shouldn’t take
» that many years for FDA to approve unlike real cell culturing that
» Intercytex and Aderans are attempting to do.

Says who?

67

Can someone tell me in simple English what is WNT signaling, how does it work for hair loss?

68

» Can someone tell me in simple English what is WNT signaling, how does it
» work for hair loss?

Please allow me, the copy and paste master :slight_smile: I found this on Wikipedia, very interesting read:

Traditionally, it is assumed that Wnt proteins can act as Stem Cell Growth Factors, promoting the maintenance and proliferation of stem cells.[20]

However, a recent study conducted by the Stanford University School of Medicine revealed that Wnt appears to block proper communication, with the Wnt signaling pathway having a negative effect on stem cell function. Thus, in the case of muscle tissue, the misdirected stem cells, instead of generating new muscle cells (myoblasts), differentiated into scar-tissue-producing cells called fibroblasts. The stem cells failed to respond to instructions, actually creating wrong cell types.[21]

Understanding the mechanisms by which pluripotency, self-renewal and subsequent differentiation are controlled in embryonic stem cells is crucial to utilizing them therapeutically. Additionally, control of Wnt signaling may allow for minimizing the use of animal products, which can introduce unwanted pathogens, in stem cell cultures.[22] Wnt signaling was first identified as a potential component to differentiation because of its established role in development. Recent research has supported this hypothesis. There are data to suggest that Wnt signaling induces differentiation of pluripotent stem cells into mesoderm and endoderm progenitor cells.

There are several pieces of evidence to suggest that Wnt signaling is important in stem cell differentiation.[23] TCF3, a transcription factor regulated by Wnt signaling, has been shown to repress nanog, a gene required for stem cell pluripotency and self-renewal.[24] Over expression of another gene associated with pluripotency, OCT4 leads to increased beta-catenin activity, suggesting Wnt involvement.[25]

Studies of embryoid bodies (see embryoid body) have led to new insights regarding the role of Wnt signaling in human embryonic stem cells. Researchers at Stanford School of Medicine observed that embryoid bodies spontaneously begin gastrulation.[26] They determined that gastrulation in embryoid bodies mimics the in vivo process in human embryos; in vivo gastrulation has been previously linked to the Wnt pathway. Formation of the primitive streak in particular was associated with localized Wnt activation in the embryoid bodies. Once the Wnt pathway is activated, it is self-reinforcing. It is unclear, however, what induces the initial Wnt signaling that begins gastrulation.

Research published in the Journal of Biological Chemistry has suggested that activation of the Wnt pathway in mouse embryonic stem cells induces differentiation into multipotent mesoderm and endoderm cells.[27] This study showed that upon inducing Wnt signaling in mono-layer embryonic stem cell cultures, the cells express high levels of markers associated with mesoderm development, particularly T-brachyury and Flk-1. The cells also expressed high levels of Foxa2, Lhx1, and AFP, which are associated with endoderm development. The progenitor cells created via Wnt activation seemed to have particularly high potential to differentiate into bone and cartilage. The researchers suggested that beta-catenin plays an important role in skeletal development. They demonstrated that the progenitor cells could also develop into endothelial, cardiac, and vascular smooth muscle lineages.

A publication from the American Society of Hematology extended the previous study to human embryonic stem cells (hESCs) by demonstrating that Wnt signaling can induce hematoendothelial cell development from hESCs.[28] This study showed that Wnt3 leads to mesoderm committed cells with hematopoietic potential. Over expression of Wnt1 led to faster, more efficient hematoendothelial differentiation than Wnt3 over expression. Wnt1 has also been shown to antagonize neural differentiation; this observation suggests a variety of roles for the Wnt pathway in stem cell activity. In contrast to Wnt3, which is associated with mesoderm and endoderm differentiation, Wnt1 serves the opposite function in neural stem cells. Wnt1 appears to be a major factor in self-renewal of neural stem cells. Wnt stimulation is also associated with regeneration of nervous system cells, which is further evidence of a role in promoting neural stem cell proliferation.[29]

69

also from wiki

WNT Protein Introduction

In May 2007, U.S. company Follica Inc, announced they have licensed technology from the University of Pennsylvania which can regenerate hair follicles by reawakening genes which were once active only in the embryo stage of human development. Skin apparently can be brought back to this embryonic state when a wound is healing. Hair growth was discovered in the skin wounds of mice when Wnt proteins were introduced to the site. Development of a human treatment is expected to take several years.[23]

70

» Suit yourself.
»
»
» But, thinking you’ll be in the phase#3 trials? You and every other guy
» who is wrapped up about his MPB. There are millions of us.
»
»
» Just look at the trials for ICX-TRC. All I ever heard around here is how
» fast it should happen, and then how they were always missing deadline after
» deadline. Right? Except that when you stand back and look at the big
» picture, they took about 2/3rds of a decade to get through 2 stages of
» the 3. So were their trials really “falling behind” all the time,
» or were we just deluding ourselves about the real timeline for the trials
» process?

I don’t think i will be in any trials, that was posted on another message board by someone who has researched the FDA trials because he was sick of hearing people who don’t know what they’re talking about giving people false information.

I don’t know when they will finish the trials, just like the people who continually act like they know the ins and outs of medical trials don’t know when they will finish trials.

It’s a pretty simple situation really, people should stop speculating about timelines because we don’t have enough information available to comment.

71

» This might be a stupid question, but are the trials they’ve been doing (the
» ones they’ve just reported on) Phase 1?
»
» Or were they just “pre-FDA approval process” unofficial trials? I know
» they were just testing for safety etc but I was wondering if they could use
» these trials as Phase 1 if they wanted to? I know Phase 1 is normally
» small-scale and normally to do with safety but there certainly doesn’t seem
» to be much difference involved between the number of triallists in this
» trial and say, for example, the number of triallists in ICX’s Phase 1
» trial.

Your right IIRC, I’m sure Histogen said previously that the trial they just completed was phase I FDA trial.