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

Dr. Robert Jones now has access to Acell’s Extracellular Matrix (ECM) products for wound healing. Anyone interested in signing up as a test patient, please email hairsite@aol.com immediately for details.

From Hairsite

Read more about ACell on the Tressless Wiki

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