Histogen removed its hair research timeline and anticipated release date of its hairloss treatment from its main page. Any thoughts?

Gail Naughton the presentation below at TERMIS in Singapore in August.

Theres no new info there and it only an abstract but at least they are still talking about HSC.

Human Tissue Engineered Soluble ECM Stimulates Hair Growth While Inhibiting Cancer Cells GK Naughton

ABSTRACT
Research has shown the importance of Wnt 7a, follistatin, and wound healing growth factors on the stimulation of bulge cells and inter-follicular stem cells to induce hair growth. We have developed a bioengineered human cell-derived formulation, termed Hair Stimulating Complex (HSC), consisting of such growth factors and morphogens. These factors are secreted neonatal fibroblasts seeded on microcarrier beads grown in suspension cultures under hypoxic conditions simulating the embryonic environment. Under these conditions over 5000 genes are differentially expressed as compared to normoxia and follicular stem cell surface markers are expressed, including LnX2, SOX 21, Nestin, NFATc1, and Krt 15.Following preclinical safety and efficacy studies in the C57Bl model, a clinical pilot study was undertaken. The double-blind, placebo-controlled, randomized single site trial was primarily designed to evaluate safety of the HSC product with efficacy being the secondary goal. Data analysis indicated that HSC is safe and showed effectiveness in stimulating hair growth in subjects with male-pattern baldness. All subjects tolerated the procedures well and no adverse reactions were reported. The improvements from HSC treatment were significantly greater than that observed in placebo treated sites: hair shaft thickness (6.3% + 2.5% vs. -0.63% + 2.1%; p = 0.046), thickness density (12.8% + 4.5% vs. -0.2% + 2.9%; p = 0.028), and terminal hair density (20.6 + 4.9% vs. 4.4 + 4.9%; p = 0.029). Similar trends were seen at 52 wk, with total number of hairs increasing on the HSC-treated site. In addition, cancer lines have been "reprogrammed" by co-culture with embryonic ECM. Research with our embryonic-like soluble ECM has demonstrated its ability to diminish or eliminate tumor load in over 20 cancer cell lines, including melanoma, adenocarcinoma, colon cancer, glioma, mesothelioma, and prostate cancer, both in vitro and in two animal models. In the tumor chorioallantoic membrane (tumcam) model hECM significantly inhibited tumor growth with tumor mass being reduced in weight by up to 80%. In subcutaneous mouse experiments, tumor growth was also inhibited from 70-90% among the same cancer cell lines. The inhibitory affect is selective for malignant cells. Whereas most cancer therapies target rapidly dividing cells and not cancer stem cell, hECM has been shown to target both cell types through the upregulation of Caspase 9 which forces the cells into apoptosis.


Notes
Date: 3th August 2011 Time: 1215-1230
Venue: Waterfront Ballroom I, Grand Copthorne Waterfront Hotel

Anyone emailed them about this by chance? There's a possibility we'd get an explanation... although the fact that they removed this, in my opinion, is a pretty blatant sign that they are way behind schedule or worse.... (sigh) I had big hopes for them too....

-------------------------
Maxster

Someone on hairsite sent them an email in mid August and was given this reply.

"Thank you for your continued interest. Although HSC continues to progress, we are not releasing any details about the Singapore clinical trial at this time. We do look forward to sharing the preliminary results of that trial in the coming months.

Thank you, and hope you are well.


Eileen"

I have to give you all a bad news. I got HSC injected to my scalp about 5 months ago at Akai Clinic in Tokyo, Japan. Dr. Akai told me that he is collaborating with Histogen in this research, and got the HSC before the market release. The treatment was divided into two phases. First injection and the second one roughly 6 weeks after the first one. Each treatment costed me about $2500 (315000yen), but unfortunately, it did me no good. I have also gathered info about the others who got HSC treatment from Akai from Japanese internet forum, and it seems that the consensus is that HSC doesn't work, or at least, has not yet produced the result we wanted. I suspect that the trial in Singapore is not going too well either, and that is why Histogen is not releasing information.

oh jeez that was laughable, nice attempt to stir things up, but you can go away now and troll somewhere else

MintyFresh, why immediately jump all over the guy when you have no confirmation he is a troll?

He is posting from Japan. Why would he make this up?

-------------------------
Disclaimer - I am not a physician or an expert and my advice should not be considered medical/expert advice. - If you follow my opinions and/or advice you do so at your own risk.

OK fair enough, I was a bit quick to judge,

I would like to know what Histogen have to say about this, if this is part of the trial then why on earth are they charging anything let alone thousands of dollars?

if hage is being genuine then maybe he should consider that he might have been scammed before writing such a definite direct attack on Histogen and their research

The thing about Akai is serious, if Akai themselves are not scammers.
http://metropolis.co.jp/specials/862/862_top.htm

Histogen must be asked about it.

this is some text from Akai blog (translated from Japanese)
http://translate.google.com/tr....exblog.jp%2F&act=url
----------------------------------
Hair regenerative medicine by HSC


From the U.S. Histogen's HSC, a certain amount was imported.
Regenerative medicine has resumed hair with HSC.

This protocol is
Injected 6-8 weeks and again after the first injection, and two treatments.
HSC is by injection, is injected into the scalp to ensure.

Per vial, about 3.5ml of the chemical can treat an area of ??9 × 9 square centimeters of this amount.
However, the concentration is varied depending on the patient.

Treatment cost is ¥ 315.000 in one vial.
For observation of curative effect, you need a photo shoot.
Basically, before treatment, 6 weeks after initial treatment, 12 weeks, 18 weeks, 24 weeks, 32 weeks, 44 weeks, will be taken at the time of the year. For patients with distant, will be consulted individually.
After treatment, injection site swelling and discomfort, there may be bleeding from the later needle-like point.
The injection site did not give a stimulus, when there is bleeding, please press it down lightly with gauze, etc..
Before the treatment immediately after vigorous exercise, please keep the treated area to rest.
In about 12 hours after treatment and shampoo are available.

Than before, we let me touch You're starting from registered patients.
When you receive the call, the nature of medicine, I look forward to hearing from you early.

Thank you.

If you would like counseling, please register first.
Step, you will be contacted here.

Register listed items are as follows.

Name (full name) the therapeutic range previously treated Address Telephone e-mail address, age, gender ·

Thank you.
--------------------------------

@mintyfresh

Just curious what would be this guys motive, could he be the competition trying to ruin Histogens reputation ?

-------------------------
FIN_ 1.25mg (AM)

KIRKLAND MINOXIDIL 5% Foam (morning/nights)

Spectral.DNC-N
(Nightly)
Coconut Oil
Nizoral
Biotene H24 shampoo (EOD)
Biotin B-Complex conditioner
Fresh Ginger rub before bed minox 15min later
Hair loss oils.

Accept things the way they are not how you wish it could be, but fate can be so cruel

I asked Histogen but no reply yet.Send an e-mail or call them everyone.

Hi, below is the email reply i got from Dr Gail Naughton herself:

Dear Terence,

Good to hear from you.

Shortly after our most recent trip to Singapore at the end of August we decided to pull our filing and submit an IND elsewhere in Asia. Part of our concern was that a large percentage of potential participants were using Minoxidil and/or Propecia, both of which disaqualify them as patients. A minimum 6 mos wash out is required. Our plan is to conduct part of our Phase 3 trial in Singapore and give the clinicians there adequate notice before beginning it to select appropriate participants and have them stop treatment with the other hair growth drugs.

As I write this my clinical director and I are on our way to Alaska for the International Society of Hair Restoration Surgery annual meeting where our two year follow up hair study and some new applications for our product will be presented by both Dr. Craig Ziering and Dr. Neil Sadick. Our IND is under review in Asia and we are finalizing our regulatory strategy for North America. We will send out a formal statement shortly and remain excited by the level of interest in HSC from both clinicians and patients.

Please stay in touch.

Take care,

Gail





From: Terence Lee [mailto:mreldarlmari@yahoo.com]
Sent: Monday, September 12, 2011 6:35 AM
To:
Subject: Inquiry for Phase 2 Clinical Trial of HSC



Dear Dr Naughton,



Greetings, I recently attended the Meet & Greet event held in Singapore during the month of July 2011 on the HSC phase 2 trial amongst other enthusiastic participants and was very glad about the detailed information conveyed to us on what HSC is all about, etc. Thereafter nearing the end of the function, you mentioned that the subject selection would be taking place soon after and that we(interested participants) would be contacted via email. However, I have not receive any emails pertaining to this matter yet.



May I know when is the suject selection taking place? Your kind reply would be very much appreciated.



Thank you and have a nice day.



Regards,

Terence






P.s blanked out the email part address part

Edited: 09/20/2011 at 02:44 PM by eldarimari

If they apply for a new IND in a different country does the trial have to start back at phase 1?

Can you transfer results from a clinical trial for one country's drug administration to another?

I don't know much about the drug approval process.

if you read the thread, we discovered that he's being truthful about receiving something from Akai (check the post above yours)

whether it's actually HSC that he was treated with we'll have to see what Histogen have to say on the matter

Eldarimari, do you post under the alias CVAZBAR at the bald truth forum?

A poster called CVAZBAR received the exact same reply about 2 weeks ago.

Am I the only one concerned by this new IND crap? Surely they can find 2 dozen balding men in Singapore who don't use min and fin! Remember they estimate only 7% of balding men actually treat their hair loss.

I have a terrible feeling that they have nothing and they are trying to extend the trial. When it fails they will have nothing to keep investors paying out. By extending the trial (i.e. postponing the failure) they they keep the cash rolling in while they look for something else.

So, that's what it is? In order to keep the cash flow from the investors, they're extending the trial? I suppose that makes sense. That explains why Histogen was doing the trial in Japan without publicly announcing it. If they fail in the official trial, they'll lose the money. I guess I should've known better when Dr. Akai told me that the treatment was divided up into two phases. Probably, they had known that one injection of HSC doesn't do the job, and they were hoping two would...

@Boyfromoz:

nope. in fact, this is the only hair loss forum i joined.

I have the same feeling that they are just hiding something and using the 'fin+minox" issue as an excuse

I believe you can 'cause if a drug is approved by FDA most countries will approve it too without any tests.

I hope you're right. If it goes back to phase 1 I think we can kiss it goodbye.

As for this Dr Akai, I don't know what to think about him. If Histogen applied for clinical trials in Japan I'm sure we would have heard about it. If hage did participate in a trial he wouldn't know if he was in the placebo group or not.

And as per Minty's comment, it is very unusual that anyone would pay to be in the trial.