And it is good. Trialists were given only one application of Histogen’s Hair Stimulating Complex (HSC), and in some cases gained 73% more hair in the application area.

HSC seems to be a relabeled version of their ReGenica product line, and is essentially a soup of fibroblast cell secretions– the same growth factor-rich cells that produce the extracellular matrix (ECM) components used by companies like ACell. Histogen claims a “proprietary bioreactor” that coaxes cells into embryonic states via “low gravity and oxygen” is used to generate their product. Whatever the source, one application of a product yielding this much after a year is very big news. This is your own hair with no surgery and no lotions.

During this study, patients received four types of scalp injections:

1. One placebo injection
2. One regular HSC injection
3. One dermabraded area with regular HSC
4. One area with a higher concentration of HSC

Dermabrasion is known to call growth factors to the wound site, and is one of the guiding techniques of similar-aiming Follica. In this case, however, the higher concentration of HSC on non-dermabraded areas reportedly performed the best, with both hair thickness and density increasing. Existing hairs looked better, new hairs popped up where none existed. It’s not clear yet what upper limits may exist with multiple applications or further variations of solution strength. It’s possible that more secret sauce gives even more hair.

Gail Naughton

Histogen founder and CEO, Gail Naughton, has been extremely transparent and forthright in comparison to other biotechnology companies focusing on hair (I’m looking at you, Intercytex and Follica). This may be necessitated due the funding woes of bootstrapping, but the benefit is mutual and her plainspoken rapport is quickly developing an eager audience.

Naughton is also clever enough to redirect studies and launch goals to areas of the world that don’t have as much regulatory tape and cost; this study was in Honduras, the next will be double the size at 50 patients in Singapore come June, and the last should add over 200 patients from Hong Kong, India and South Korea to that list in spring 2011.

Pilot trials helmed by Dr. Craig Ziering are planned for the US, but only for topical application ala Rogaine, not injections beneath the scalp as in this study. Given Naughton’s confidence with HSC’s safety profile in injectable form, it stands to reason that these trials would be more of a regulatory foot in America’s door, and we baldies will be taking an Asian vacation.

Histogen has had a rocky road this past year, being sued by dreamkillers SkinMedica, who claim Naughton is reusing technology from her previous company they had purchased patents from. Naughton disputes this claim, but the verdict is still out. In the meantime, this spooked the initial investors, who withdrew completely, taking all 36 employee’s payroll with them. 20 employees then volunteered to stay unpaid, presumably for equity and out of confidence in the company’s direction. There are some casual reports that $4.4 million was raised to sustain the employees, and that additional funds have been secured for the following trials, but this has not been confirmed.

More results from the trial are expected on May 5-8 at the Society for Investigative Dermatology Annual Meeting, and you can read the press release here.

Read more about Histogen in Tressless > Learn

Without pinning himself to a timeline, the good doctor’s estimate for Follica’s treatment looks very possible for launch within the next five years. “It’s impossible to know for sure, but within the next several years — two to three — there’ll be a trial where we’ll use a procedure with the compound to see if it works in humans,” says Cotsarelis. “There will be the usual regulatory stuff after that, so perhaps in four to five years we’ll have something we can offer people.”

link to article

Read more about Follica on the Tressless Wiki

He only looks sad still; he died while waiting for hair

Intercytex, the UK-based biotechnology company and hair multiplication darlings of the moment, have released the final results from their Phase II trials for their flagship hair product, ICX-TRC.

The last results were in September, leaving us with extremely promising results and the impression that they were ironing out the kinks.

They appear to have found more consistency this time around, but are oddly backing out of further development and commercial production, saying only that they’ve left the option open for a hair transplant specialist company to swoop in and take over, with Bosley getting first crack.

Hot off the press:

We have now completed the treatment phase of our Phase II study, being conducted by Dr Bessam Farjo in Manchester, to optimise the delivery of the DP cells.

In this study, hair counts are obtained by shaving and photographing a small section of scalp, injecting it and then applying a specialised image analysis system to provide a total hair count. All 19 subjects in the trial have now been treated using a range of injection and scalp pre-stimulation techniques; the first 6 subjects were injected without stimulation of the scalp. In the remaining 13 the resident hair producing (epithelial) cells were stimulated at the time of delivery of the DP cells.

11 subjects have now passed the 24-week time point since treatment and specialised image analysis at this time point showed:

• Of the group of 6 patients without stimulation of the scalp, 3 had an increased hair count and
two had a reduced hair count; one has been lost to follow-up.

• Of the 5 subjects with pre-treatment scalp stimulation, all had increased hair count at 12 weeks and the 3 who were evaluable at 24 weeks all had an increased hair count at that time point.

These data are consistent with the earlier data reported last September and the hypothesis that new hair production is improved by pre-stimulation of the scalp, leading to an interaction between the injected cells and the resident hair producing cells.

24 week data on all subjects in the trial will be available in September 2008 and at the end of the trial photographic data will be analysed from a much larger area of treated scalp on all subjects at 48 weeks.

ICX-TRC overcomes one of the principal drawbacks of conventional transplants which is that the outcome is limited by the amount of donor hair available. By using the Intercytex cell therapy technique almost limitless hair regeneration is possible in a less invasive procedure. Furthermore, treatment can commence early on in the hair loss process with retreatment available in subsequent years. The barrier to commercial success for ICX-TRC is relatively low, being the ability to increase hair count in transplanted or thinning areas.

We believe the continued development of ICX-TRC would best be carried out in partnership with a specialist in the aesthetics field. We do not intend to finance the continuation of clinical and commercial development of ICX-TRC beyond the current Phase II trial and shall seek to sign a partner when we have the complete data package from this trial. Intercytex has granted Bosley, the largest chain of hair transplant clinics in the US, an option to negotiate distribution rights to the product.

Intellectual Property
We have split our cell delivery patent application into three separate applications in the US reflecting additional techniques that are being developed. We have also filed a patent application relating to our
observation that epidermal stimulation pre-treatment appears to enhance hair follicle formation.

Two other previously filed patent applications relating to the method of culturing the dermal papilla cells have been published and are undergoing international examination.

What does this mean?

• With pre-stimulation, all subjects grew hair.
• No hair counts were disclosed, which is questionable.
• Intercytex is waiting until September of this year for the final follow-up.
• They are ceasing further testing and looking to license the technology to a hair transplant company.

The big question now is their motivation for stopping further trials and cashing out. We’re left with some ambivalent phrasing: they are ceasing “clinical and commercial development” and cutting in-company financing, but are seeking a very large partner to carry out “distribution”.

It could be a sign of failure: that the technology was not successful enough to turn the profits they had hoped for without further trials, and are rats trying to sell the proverbial ship before it goes under. On the other hand, it may be that no further trials are genuinely necessary, and armed with the successful data, they are looking to pass the baton to someone with the infrastructure to carry out the procedures.

Unless a partnership forms in the meantime, we’ll have to wait until September to see how successful ICX-TRC has been.

Previously: Intercytex phase II hair multiplication trial update

Read more about Intercytex and Hair Multiplication on the Tressless Wiki

]]> http://tressless.com/2008/03/17/intercytex-phase-ii-hair-multiplication-completed-trial-results/feed/ 292 http://tressless.com/2008/03/02/regrowing-hair-with-self-mutilation-jackalopes-and-stem-cells/ http://tressless.com/2008/03/02/regrowing-hair-with-self-mutilation-jackalopes-and-stem-cells/#comments Sun, 02 Mar 2008 19:56:31 +0000 Tressless http://tressless.com/blog/2008/03/17/regrowing-hair-with-self-mutilation-jackalopes-and-stem-cells/ follicular neogenesis, a phenomenon in which new, fully functioning hair organs develop as a biproduct of trauma to the body.]]> 50 years ago, researcher Charles Breedis was taking a scalpel to the backs of rabbits at a University of Pennsylvania lab. Under a grant by the National Cancer Institute, he was investigating the link between healing and the Shope papilloma virus, a carcinogenic pathogen similar to HPV in humans.

The hide of each animal was excised down to the subcutis, a layer of loose connective tissue beneath surface skin, comprised mostly of insulatory fat. A glass chamber was placed over the wound that held the skin open, leaving only lymph secretion and scabbing to pool over the damage.

The Shope virus was a popular study in most cancer labs. It was discovered in the 1930s and proved with finality that warts are caused by viruses. It was easy to infect the host animal, cottontailed rabbits, and at the time was the only model to study viral carcinogenesis. The excitement over the virus grew to such a fever pitch that it was carried over into human trials, being used on two mentally handicapped German children with a rare genetic disease in what has been billed as the world’s first genetic engineering experiment.

The virus is also thought to be the source of Lepus cornutus, the Jackalope mythology, a kitschy American and Western European icon of an antlered rabbit. If left unchecked, it causes scaly protrusions that branch outward from the animal’s body, sometimes resembling antlers.

There were no antlers in the lab this time, but Breedis had undoubtedly found surprise in a much subtler sort of growth. Publishing his findings in a then 13 year old Cancer Research journal, he noted an unexpected behavior that would be disregarded for half a century: “It is concluded that scar epithelium … is capable of redifferentiating into hair folliclesand sebaceous glands.”

Dr. Breedis had observed the first recorded instance of follicular neogenesis, a phenomenon in which new, fully functioning hair organs develop as a biproduct of trauma to the body.

Articles recently splashed with claims such as “Skin cells have been primed to regrow hair follicles for the first time” (The Guardian), “New Hope For Baldness Treatment: Hair Follicles Created For First Time” (Science Daily), and “First demonstration of new hair follicle generation” (PR release) carried more than a little unintentional hyperbole, but that probably doesn’t bother the accolade’s recipient, Dr. George Cotsarelis. He has rediscovered follicular neogenesis in the very same University of Pennsylvania. It seems the Breedis tomes had been lost to dogma in his own alma mater: “We noticed that after wounding the mice, they developed hair in the middle of the wound,” Cotsarelis said in an interview with ABC Australia, “So we thought something had gone wrong.”

The concept had risen from the ether, just as our would-be Jackelope’s fur had done so many years ago, and the idea that skin cells can be coaxed into transformation is now mainstream and well accepted.

Cotsarelis has led the charge to commercialize the concept this time around. He is listed as a co-inventor on the patent owned by the University, and is a co-founder, board member and advisor in a start-up company called Follica that has licensed the same patent. Cotsarelis also has his hands in Aderans Research, a leading institute in hair multiplication that is associated with Bosley.

It’s been long speculated that our ability to regenerate ourselves was lost somewhere in the evolutionary ladder. In its place, we gained scarring’s quick fix and the infection-fighting powers of inflammation. We do still have some limited regeneration abilities: children before the age of ten can grow back fingertips, an adult’s liver will regenerate itself if enough of the original is left, and ribs are harvested for source material in graft surgeries because they grow back under specific circumstances.

Embryos are another story. Animals, including humans, in an embryonic state will heal almost perfectly when injured within the womb. Around 16 weeks we lose the ability as our immune system begins to rise in power. It had never been conclusively shown that an adult human can regenerate anything near this capacity until very recently.

Damage to the skin activates growth factors which include a class of around 20 proteins known collectively as Wnt. “Wnt” is a concatenation of the Wingless and Int genes, two separate discoveries. Genetic Gemini of sorts, they share parts in a gamut of interactions, from embryo growth to cancer. Duplicity is written into their nature, just as these wounds give rise to new life.

Follica’s plan is to wound the scalp with something akin to dermabrasion, then nourish the skin with unnatural amounts of Wnt, coaxing new hair out of the otherwise dormant skin.

Other companies are taking very different approaches to the same regenerative end.

Last year, an internet forum user named Raptor posting on a hair loss board emphatically suggested “THERE IS ALREADY A PRODUCT AVAILABLE that can help us to restore our lost hair”, but that “red tape must be cut to attain it”. He was referring to ACell, a Maryland-based company with a veterinary product that has been otherwise mired in litigation since 2002. The company now has several FDA clearances and is finally gaining some momentum.

Raptor’s point of inspiration was likely the publicized rehabilitation of injured animals shown completely healed from devastating wounds, including hair that seamlessly crawls across what would otherwise be scar tissue. It was suggested that ACell be applied after cosmetic hair transplants, potentially regrowing hair in the small holes that are left from the extraction site. This would effectively be an unlimited supply of hair, multiple surgeries be damned.

Extracellular matrices, the technology behind ACell’s product, have actually been over 20 years in the making within regenerative medicine. Stephen Badylak first discovered the strange behavior while working a Purdue University lab. From this work, matrices have been used in humans since the 90s in upwards of half a million people. It usually comes in the form of sheet-like patches known as grafts which are applied directly to a wound, internal or external.

An extracellular matrix is the scaffolding that cells are held in and communicate through, though it serves many other functions, including managing growth factors and influencing the development, migration and shape of the cells around it. It’s the supporting cast by which the main actors would have no play without.

The real coup comes when the matrix is extracted and placed locally into a wound site. Signaling molecules go to work, redirecting stem cells to create new tissue, blood vessels, hair, sometimes even new bone. The matrix puts the patient’s wound into an embryonic state. Little known to the patients, the product is actually a mucosal membrane removed from animal innards. A big blanket of sausage casing.

Strangely, even a matrix from a different species yields the same results when placed in a wound. Rejection is said to not be a problem because it lacks the regular cells that are detected and attacked by the host body, and Badylak has been cited as saying that no significant side effects have been found in the decades of research.

The patents were first licensed out for orthopedic use to what is now a division of Johnson and Johnson, but are currently being used in multiple companies with many applications. Cook Group Inc., is one such company, basing its more than 100 products on the technology. Their “OASIS Wound Matrix” product alone is “indicated for use in all partial and full thickness wounds and skin loss injuries as well as superficial and second-degree burns.”

There is absolutely no reason to think this couldn’t be applied to hair transplant patients…

Part II coming soon

Follica’s co-founder, George Cotsarelis, is shown predicting a market release “within a few years” under “perfect” circumstances. It is also confirmed that human trials should begin “within the next year or two”.

Link to video on MSNBC’s page

We had big expectations.

Our pre-millennial pipedreams were always clear; “The Year 2000″ was to be splashed above our lives like a marquee of technological miracles: jetpacks, robot maids, holograms, hoverboards, cure for cancer, cure for ugly, no more woes.

Cut to 2007 and the best we’ve got are iPods, vacuum robots that bump into furniture legs like retarded pets, cars that use a little less gasoline than your 1976 Monte Carlo, and every genetic defect we’ve always had. We’re still a bunch of disgruntled bald guys that can’t do a fucking thing about our shiny pates but ingest pharmaceutical poison and rub lotion on our scalps that smells like burnt condoms. But we can do it while listening to iPods!

I need hairloss with a slow hand

Not much has changed since 1997 when Propecia (Finasteride) forked from its prostate treatment roots (Proscar) to combat baldness. That marked the last FDA approved drug to treat hairloss, and is still only the second product to ever be cleared to this day. The first product, Rogaine (Minoxidil), was approved almost twenty years ago in 1988.

The vast majority of hairlosers attempting to self-medicate will typically stick with a combination of these two, complimented with similarly acting natural supplements and off-label uses of other drugs.

There’s a palpable sense of helplessness that comes with losing one’s hair; this is clear in the adolescent expectations that carry each new treatment forward, a reckless faith that however dubious the source, says this may finally be the thing to free you from your affliction and self-loathing. Every year becomes littered with the remnants of uncertainty, lost hope and disappointment.

Some things are always certain; enterprising cunt wafers entrepreneurs still continuously capitalize on men’s desperation and put out product after product of pseudoscience nonsense that read like the ads for x-ray goggles and hovercraft plans in the back of a boyscout magazine. Here’s a few recent favorites:

• Lasercomb: a device that shoots Deathstar lasers at your head while you brush hope into the space where your hair used to be.
• Toppik: a glitter kit for grown men containing baldspot glue and a salt-shaker filled with black spacedust. Just don’t go swimming. Or lay on pillowcases. Or people.
• Avacor, Folliguard: Why pay $15 for a jug of Minoxidil, the twenty year old drug, when you can pay $350 for what amounts to Minoxidil mixed with elephant toenails and strawberry jam? Nice try, fucking Harry Potter marketeers.

Some success can be found with current treatments. The recurring theme among almost all successful therapies is suppressing DHT, but this will always be a losing battle. Some men have regrowth, some don’t respond well, most just slow down the inevitable. Sprays, creams, pills, shampoo, concealers, hats, hairpieces– it gets to a point where the burden of maintenance and obsession outweighs the trauma of losing your hair in the first place.

On the off-label drug front, Nizoral (Ketoconazole), a drug normally used to treat dandruff in shampoo form, has been a popular additional treatment for hairloss in the last few years. Finasteride’s successor, Dutasteride, is being used for hairloss, but it isn’t the knockout champion as initially hoped. Topical Spironolactone is popular too, and also makes the rounds in the transsexual circuit as a chemical castrator. “I rub anti-man on my head”; quite the conversation starter.

Naturalists tend to concentrate on various antiinflammatories, Saw Palmetto being the main exception, used as a pussy natural alternative to Finasteride.

More extreme experimentalists will go for homemade concoctions and grey market drugs from other countries, like RU58841. A different mixture containing boric acid and requiring a lengthy stovetop preparation was popularized by a Japanese forum user named Waseda several years ago.

In the world of hair transplant surgery, limited donor hair will always be a problem. You’re basically taking evenly distributed hair from one area and putting it in another area, balding Peter to pay Paul. Some doctors have resorted to using extracted body hair, which is great news if you’re Robin William’s knuckles, but probably not so great otherwise.

Hair on the horizon

There’s a joke amongst hairlosers about every good treatment being perpetually 5 years away. For the first time in history, this may actually be an overestimation.

Several companies have been developing techniques to extract the loss-resistant follicles at the back of men’s heads, duplicate the cells, then inject them into the balding areas. This is commonly referred to as Hair Multiplication. True, it isn’t the ideal, which would be a vaccination against your own natural loss, but goddamn if this isn’t good enough. It’s expected to be cheaper than existing hair transplant technology, but there are still some unknowns about quality.

Leading the pack is Intercytex, a UK-based biotechnology company. They released the results of their phase II trial recently. Make no mistake about it; this is an exciting time. Not exciting in the sense of not looking like “that bald asshole” to the women across from you, but exciting in that we can see a finite amount of time left until that is obtainable.

Stay tuned!

“The thing that hair cloning means is that for the first time the ability to get past the limitations of the amount of donor hair you have. This will be the first time you can actually make more, if you need more,” says Dr. Ken Washenik, Medical Director of Bosley Hair Instititute.

“We can get a hair follicle to form in as little as eight days, but in the human it will probably be similar to when you move an intact follicle and it will take around twelve weeks or three months for that follicle to organize and grow up through the skin so about the same time,” says Dr. Washenik.

Aderans is closely associated with infomercial fixture Bosley, the world’s largest hair transplant company. It’s no surprise that that every mention of Aderans is trailed with a plug (sorry) to traditional hair transplants, usually suggesting that hair multiplication will be used for filler hair toward the back alongside the conventional surgery toward the hairline.

This technology will be used to augment or add to the density you can get from a conventional follicle based transplant.

It’s also revealed that Phase I trials have been underway in England and will begin soon in the US, pending FDA clearance. Aderans is famously behind schedule, having originally predicted approval and launch within 2007. If clinical trials begin now and everything goes swimmingly, we’re looking at atleast another 3 years to market in the US.