UPDATE: In August 2017, the company issued a Q&A about the clinical study results with RCS-01 for aging and sun-damaged skin with prominent skin aging researcher Prof. Dr.med Jean Krutmann, who said, "The novelty of this cell treatment is that it directly affects and interacts with the dermis and is capable of modulating gene expression in the treated skin. For us this means we expect it will likely show long-term effects on the aesthetic effects of skin aging – in other words, positively impact the skin wrinkles and appearance."
In September 2017, the company announced functioning prototypes to showcase to potential end users and licensing partners. In January 2018, the intent to form a strategic partnership was announced between RepliCel and YOFOTO, a Chinese health and consumer products company, which became finalized in May 2018. According to the company, YOFOTO will receive an exclusive license for RepliCel’s tendon regeneration cell therapy (RCT-01) in development, skin rejuvenation cell therapy (RCS-01) in development, and its injection technology in development for dermal applications (RCI-02) (excluding hair-related treatments) for the Territory.
RepliCel Life Sciences made three announcements in 2017 regarding successful phase 1 studies of its novel skin and hair regenerative therapies and that they’ve secured a U.S. patent for a technology to deliver those investigational therapies. In March 2017, the Vancouver-based company announced its pipeline autologous cell therapy, RCH-01, for treatment of male and female androgenetic alopecia, successfully completed a phase 1 clinical trial for hair loss, establishing the product’s safety and showing promising signs of stabilizing further hair loss and increasing hair density.
RepliCel’s RCS-01 autologous cell therapy, aimed at reversing the effects of skin aging and sun damage, also delivered successful safety results in a phase I skin trial. It significantly impacted biomarkers scientifically correlated with collagen production — a factor highly associated with skin rejuvenation, according to an April 4 company news release.
And in late April, the company announced they were issued a U.S. patent for their multi-needle dermal injection device. The technology, if it pans out in studies, will be used along with RepliCel’s proprietary cell therapy products targeting pattern baldness and aging or UV-damaged skin, as well as for other injectable products.
Rolf Hoffmann, M.D., RepliCel’s chief medical officer and a dermatologist by training, describes RCS-01 as a therapy that uses specific fibroblasts from the skin, under the hair.
“These fibroblasts come from the dermal sheath, which is the specific structure around the hair. The hairs are harvested from the back of the head. By definition, those hairs and consequently those fibroblasts have never seen UV light, so they are UV naïve. These cells, by their nature, make more collagen than the surrounding skin fibroblasts,” Dr. Hoffmann says.
The process involves harvesting and culturing those UV-naïve cells and injecting them back into UV damaged skin — especially the cheeks, neck, décolleté and backs of hands. Conceptually, the autologous cells should diminish fine wrinkles and make more collagen in the injected area, he says.
Skin, Hair Technology
Dr. Hoffmann says he and colleagues noted in the phase 1 study looking at the safety of RCS-01 that one month after the last injection, there was more collagen production in the treated area vs placebo.
“This makes us confident that in the phase 2 trials, where we look for efficacy for wrinkle depth and wrinkle diameter and so forth, that we will see efficacy,” he says.
If successful and approved, the injection of autologous UV-naïve cells into sun-damaged and aging skin could replace laser and other mechanical skin rejuvenation approaches, according to Dr. Hoffmann.
“It’s a minimally invasive technology that retrieves those cells. It’s a small punch biopsy, just 6 mm in diameter,” he says. “That’s something every dermatologist does every day. You just need one or two stitches, and then it heals. The scar that’s left behind is in the hair area, behind the ear, so you don’t see a scar.”
RCH-01 for hair loss is a similar technology but uses cup cells from the hair root. The procedure would also involve taking biopsies from the back of the head.
“These cells are able to make new hair and thicker hair,” Dr. Hoffmann says. “We’ve completed a phase 1 trial on this and are getting ready to do a phase 2 trial. If this works, it would replace the rather invasive procedure of hair transplant.”
Researchers reported no serious or systemic events in the five years of the phase 1 RCH-01 study on pattern baldness.
Next-Gen Dermal Injection Technology
While the effects of treatment on skin and hair rejuvenation would come from the cells used in RepliCel’s pipeline products, the products are expected to work best with the company’s patented dermal injector.
“If you have a single syringe and single needle, you cannot distribute cells in a very homogenous way to the skin. It’s not possible. And everybody would do it differently,” Dr. Hoffmann says. “That is why we are on the way to have our first prototype ready for an injector, which is the first injector of its kind to inject cells, fillers, botulinum toxin or whatever, in a very homogenous way and in a three-dimensional way.”
The company says its next-generation dermal injection technologies are capable of resulting in new levels of precision and control to any substances injected into the skin.
The first prototype for the technical testing should be ready by the end of July or August. If the injector achieves European regulatory approval, the CE mark, RepliCel plans to license its use to filler and other companies, in addition to using it with its proprietary products.
“While it is expected the dermal injector will optimize the injection of many different types of products into the skin, you need the injector for the cell treatments. The next trials of the cell treatments, phase 2 trials, will be with the cells and the injector,” he says.
RepliCel also has a pipeline product aimed at tendon regeneration, which also uses retrieved, specific, fibroblasts to do the work.
“These fibroblasts are specific because they just make more collagen. Because they make more collagen, these cells are being used to treat tendons. Ninety-nine percent of the tendon is collagen,” Dr. Hoffmann says.
The Long Road to Approval
Boca Raton, Fla.-based hair transplant surgeon Alan J. Bauman, M.D., says it can be a long road to biocellular rejuvenation product approval.
“Companies like RepliCel/Shiseido and Integra (BioD) are working hard in the field of biocellular rejuvenation, amplifying the body’s ability to heal itself,” says Dr. Bauman, who is medical director of Bauman Medical. “The sad part is that in the long extended time it takes for these companies to test, refine and bring their products to market, hair loss sufferers can lose a significant amount of hair if they delay evaluation and intervention.”
The good news for patients, according to Dr. Bauman, is there exist a multitude of effective treatments to halt and reverse the progression of hair loss available now for patients who need treatment and restoration.
According to Dr. Bauman, although efficacy was not a primary endpoint of RepliCel’s phase 1 scalp trial with the RCH-01 product, the study showed about 6.1% increase in hair density.
“This puts it slightly behind traditional hair regrowth treatments like pharmaceutical, laser therapy and [platelet rich plasma] PRP, but it is definitely something exciting to watch as more data is obtained… especially if they can show improvements in Hair Mass Index (HMI), using HairCheck [Divi International] bundle trichometry, a measurement more closely related to the overall hair volume growing from the scalp,” Dr. Bauman says.
