Hair multiplication, also known as hair cloning, is a cutting-edge technique aimed at countering hair loss. This approach involves extracting healthy follicle cells or dermal papillae from areas of the scalp unaffected by baldness. These cells are then cultured and multiplied in a laboratory before being injected back into bald areas to promote hair regrowth. The technology is still in its early stages, with most groups demonstrating partial success at small scales and some companies working towards commercial development.

Shiseido

On June 28, 2024, Shiseido announced their Dermal Sheath Cup (DSC) treatment has arrived for patients in Japan, marking a significant milestone in the hair loss treatment landscape. Starting July 1, 2024, Associate Professor Shiro Niyama from Toho University Ohashi Hospital will offer this treatment using cultured autologous products now called S-DSC (the "S" is for Shiseido). More treatment facilities will follow, though no schedule has been published yet.

The treatment begins with a punch biopsy to isolate healthy hair follicles and extract DSC cells from the hair bulb. These cells are then multiplied in a growth medium and injected into the upper dermis of the scalp, where they once were expected to do everything from restore melanin pigment, sebaceous glands, and the growth of new hair fibers, but the actual results seem more modest. In a Shiseido-supported single-arm study of 36 people, 30% improved on blinded photo assessment and mean hair thickness rose about 2% at 12 months; women and people with more remaining terminal hair did better (Harada et al. 2023, PMID 37752738). An earlier placebo-controlled dose-finding study of 65 people found gains in hair density and thickness versus placebo only at the lowest of three doses, at 6 and 9 months; the effect did not last to 12 months (Tsuboi et al. 2020, PMID 32147390).

Because the cells come from the patient, immune rejection is not expected. In the 36-person study, no serious adverse events were reported over 12 months (Harada et al. 2023); longer-term safety is not yet known. The treatment needs a scalp biopsy to collect the cells. In the trials it was given to both men and women as injections at clinic visits rather than as a daily treatment.

History

In 2013, Vancouver-based RepliCel Life Sciences partnered with Shiseido, granting an exclusive license for their RCH-01 DSC cell hair multiplication technology in several Asian countries, for which Shiseido paid 400 million yen plus future royalties. RepliCel retained rights for the rest of the world. Shiseido continued trials along with some published research, and in 2021, RepliCel terminated the license agreement and initiated arbitration against Shiseido.

In 2023, Shiseido reported a small study of 36 people with no placebo group, which it called "phase III equivalent", with modest results. They published a few papers that year on identifying genes that helped cells move and integrate into hair follicles and reporting small increases in hair thickness (about 2%) in men and women in that uncontrolled study.

Other histories

In 2010, scientists at Berlin Technical University in Germany achieved a significant breakthrough by growing artificial hair follicles from animal stem cells. They created follicles thinner than normal but were optimistic about developing a method for cloning human hair from stem cells. Despite their confidence and the anticipation of a public release by 2015, the team encountered efficiency issues, cloning only one or two follicles per extracted hair instead of the required thousand for practical application.

During the same period, researchers at the University of Pennsylvania discovered that bald and non-bald scalps have the same number of stem cells. However, bald scalps showed a significant depletion in progenitor cells. This led to the hypothesis that hair loss might be due to the unsuccessful activation of these stem cells, rather than their absence. The team continued their investigations to find ways to convert regular stem cells into progenitor cells, potentially enabling natural hair regrowth on previously bald scalps.

Intercytex was one of the first companies to experiment with hair cloning, hoping to eliminate hereditary hair loss by growing new hair from a patient's own cells. It tested injections of cultured cells in people but did not bring a treatment to market.

Aderans Research Institute (ARI) also pursued hair cloning with their "Ji Gami" process. This method involved extracting a small strip of scalp, breaking it down into individual follicular stem cells, culturing, multiplying, and injecting them back into bald areas. Aderans stopped funding the research in 2013 without bringing a treatment to market.

In 2013, researchers at Columbia and Durham universities grew human dermal papilla cells as 3D spheres and showed they could induce new hair follicles in human skin grafted onto mice (Higgins et al. 2013, PNAS, PMID 24145441). More work was needed before human testing.

In 2016, Japanese scientists at the Riken Centre for Developmental Biology, in collaboration with Organ Technologies and Kyocera Corporation, reported growing skin with working hair follicles from induced pluripotent stem cells, tested by transplanting it into mice (Takagi et al. 2016, PMID 27051874). This was an animal study, not a treatment for people. OrganTech, formerly Organ Technologies, secured funding from Kobayashi Pharmaceutical in late 2022 and at that time announced plans to transplant regenerated hair follicle primordia into humans by Q2 2024.

Yokohama National University researchers made history in October 2022 by successfully cloning fully-grown mouse hair follicles for the first time. This was done with mouse cells in a lab dish and has not been tested in people.

Stemson Therapeutics, based in San Diego, partnered with UCSD and achieved a significant milestone in July 2019 by growing hair follicles on a mouse using iPSC-derived epithelial and dermal cell therapy. The hair grew straight and aligned properly with a 3D-printed biodegradable shaft. Stemson has announced plans to move toward clinical trials.

In September 2023, TrichoSeeds, in collaboration with Rhoto Pharmaceutical, announced plans to begin clinical trials in 2024. Epibiotech announced an autologous dermal papilla cell therapy, with clinical trials planned for the end of 2023. These are company announcements, and such timelines often slip.