Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

[Follicle Death Row]

Ah feck it anyway. Ken Washenik is probably telling porkies. Here's the timeline copied from the link below.

http://tressless.com/learn/Hair_Multiplication

•1941 Lillie and Wang demonstrate new feathers can be created by implanting dermal papillae in the skin. (Note: feather follicles and hair follicles are extremely similar.)

•1954 Breedis shows, under certain conditions, after complete destruction or removal of hair follicles in adult mammals, new follicles can grow in the skin.

•1956 Montagna & Chase purposely damage follicles by X-radiating the scalp. Remaining dermal papilla and ORS cells repair and regrow the hair follicles.

•1961 Cohen pioneers the use of large rat vibrissa follicles to isolate dermal and epidermal follicular components for transplantation experiments. He demonstrates implanted dermal papillae are capable of producing new follicles in the skin.

•1966 Oliver shows DP cells are responsible for regenerating new end bulbs in amputated follicles.

•1981 Oliver and Jahoda culture rat DP cells and show implanting them in wounded rat skin results in follicles that produce hair fiber resembling that of DP cell's host follicle.

•1984 Messenger shows cultured human DP cells behave in vitro very similarly to cultured rat vibrissa DP cells.

•1992 Jahoda and Reynolds demonstrate cultured dermal papilla cell induction of hair in glabrous skin (rat foot pad)

•1993 Jahoda reveals he has been successful growing new follicles in humans using cultured human DP cells. No research papers are forthcoming.

•1996 Cooley cultures his DP cells and implants them into is arm. One new hair grows as a result. The hair is later shed.

•1996 Yoshizato et al demonstrate long-term culture of hair inductive dermal papilla cells

•1997 Gho begins hair multiplication experiments. After discovering DP cells have extreme limitations, he begins using ORS and stem cells extracted from plucked hair to rejuvenate shrunken MPB human follicles.

•1999 Jahoda implants his intact dermal sheath in wife's arm and grows hair. However, he discovers his cultured DP cells fail to result in hair growth.

•1999 Intercytex is formed. Paul Kemp is Chief Scientific Officer.

•2001 Barrows of BioAmide presents paper documenting having grown hair in a human patient using cultured DP cells.

•2001 Gho states he’s aiming to introduce HM within 5 years.

•2002 Aderans Research Institute is formed. Notable hair scientist Kurt Stenn is recruited as Chief Scientific Officer. BioAmide is purchased as basis of research and Barrows is taken aboard. Washenik says he thinks it will take 5 years to have a commercially available product.

•2002 Kemp announces in best case scenario product submission could be as early as 2005.

•2003 Washenik says it will take 5 more years to release a product. Onlookers wonder why cure is always 5 more years away.

•2003 Intercytex begins phase I trials in England.

•2005 Gho continues to struggle with growing hair consistently in his human test patients. He cannot figure out why some patients respond well to the treatment and others barely respond at all. Many baldness sufferers shift hopes to Intercytex.

•2005 Intercytex completes phase I studies well behind schedule. Results appear promising. 5 of 7 patients grow hair. Kemp grows 66 new hairs from 100 injections and refers to it as an average response to treatment.

•2006 Gho misses 5-year prediction.

•2006 Intercytex begins phase II studies in England.

•2007 Aderans begins phase I studies in England. Interestingly, they use a two-cell approach compared to Intercytex’ one-cell approach.

•2008 Intercytex announces it will cease financing the development of ICX-TRC after completion of phase II completes and attempt to find a partner to finish the research and distribute the product. Many see this as a sign of product ineffectiveness. On the bright side, all patients who received pre-stimulation of the epidermis had increased hair counts. HM works in everybody. The question is, how well it works?

•2009 Aderans launched Phase II trials (April 24, 2009). Phase II of the study is being conducted in six U.S. cities: Atlanta, Boston, New York, Raleigh, Houston, and Washington DC. Currently phase II trials are taking place and it’s expected to be completed by the end of 2009. Talking about the avaliability of the HM i have heard that within 5 years. If we look back here to 2003 then Washenik told that after 5 years (2008) but now is already september 2009 and they still need 5 more years. Timline is moving and we don't know exactly when they can bring this cure to market. Hopefully by the end of 2009 we have more information about their phase 2 studies.

•2009 TrichoScience started human hair cloning clinical trials (Phase I) in Europe September 2009. It's interesting that we can see from their website the cost of the cure for the patient which is approx $16,500 - $29,500

•2009 Intercytex closes its doors.

•2010 Researchers Develop First Successful Hair Cloning Technique (with MatriStem® MicroMatrix(regenerative medicine by Acell) by Gary Hitzig, M.D. and Jerry Cooley )

•2010 Aderans Research Treats One-Hundredth Subject in Clinical Study. Aderans Research Institute Inc. (ARI) recently (February 28, 2010) achieved a significant milestone in its Phase 2 clinical study of cell-based hair regeneration, treating the trial’s 100th subject. With clinical sites expected to double in the coming months, the study will likely add dozens of additional subjects to its enrollment.

•2010 Aderans Research Institute Inc. (ARI) said today (May 4, 2010) it has expanded its clinical trials on hair regeneration by an additional seven cities in the United States. Las Vegas, NV; Los Angeles, CA; and New Hyde Park, NY, have been added through clinical site company Impact Clinical Trials. Tucson, AZ; St. Louis, MO; Birmingham, AL; and St. Petersburg, FL, have been added through clinical site company Radiant Research. Collectively, the Radiant and Impact sites will add around 80 new subjects to the study. Combined with at least twenty new additions at a site hosted by TKL Research, the second phase of ARI’s clinical study will surpass 200 subjects in total, a remarkable number of participants for a Phase 2 trial.


So back in 2002, Ken Washenik said 5 years. Then again in 2003. Then in 2009 they said 5 years. Here's how the next interview goes with Spencer:

Spencer: So what progress have you guys made? I hear you're coming to the end of phase 2? Any chance we'll see a product out in 2014 to meet the timeline?

Ken: Yeah about that...ah...We're still modifying the process for optimal results so we're going to run another 4 protocols so we're probably looking at midway through 2016 before we've got a workable treatment to bring to market.

Spencer: So the FDA process will be complete by 2016.

Ken: Well we'll have a product that could go to market but we'll have to go actually go through phase 3 to get FDA approval.

Spencer: How long will that take?

Ken: 2020...ish

Spencer 2020ish?

Ken: Then we have to train in the Bosley team so it's more likely that it will be 2022.