Cell-Based Therapy Proven Safe, But Will It Grow New Hair?

RepliCel Releases Results of 5-Year Clinical Trial

About five years ago, a Canadian company that was flying under the radar began a clinical trial on what they imagined might be a new therapy for male and female pattern baldness. The company is RepliCel Life Sciences Inc., and they’ve recently reported that the 5-year study has proven that their treatment, known as RCH-01, can be delivered safely. The findings open the door for next-phase trials.

The general concept RepliCel is examining is a cell-based extension on what the hair transplant community has been doing for decades.

To perform a hair transplant, we at Arocha Hair Restoration harvest DHT resistant hair follicles from the back of the scalp and implant the follicles in the areas experiencing hair loss. RepliCel’s therapy also harvests hair follicles from the back of the scalp, but then they isolate the dermal sheath cup cells (DSCCs) that surround the root of the follicle. They don’t use the follicle itself, but they grow these cells in cell culture to produce lots more cells – millions of cells. Then, high doses of DSCCs are injected into the areas of the scalp experiencing hair loss.

Watch their video: https://www.youtube.com/watch?v=cCe5mg7X6zg

This is just one example of the interesting and exciting developments on the research front. Some, like RCH-01, are making progress toward potentially coming to market in the next decade.

RCH-01 First Phase Trial

It is important to understand that the first phase 1 safety trial was not intended to determine if the therapy actually works – meaning if it really causes hair to grow or hair loss to slow or stop – it is only designed to test whether RCH-01 could be harmful. The company’s chief medical officer says the safety profile is “unquestionable.”

All good news! But what we all want to know is what DID the trial find in terms of hair regrowth or stabilization of hair loss?

Of the 19 test subjects, 10 experienced an increase of hair density of at least five percent after six months. After 24 months, these 10 subjects reported a sustained increase in density of 4.2 percent. While the other nine subjects did not experience hair regrowth, overall stabilization of hair loss was observed among all the patients treated.

That does not sound too exciting, which might be why RepliCel’s stock price was down five percent the day after it released these results. But if you drill a little further down, there is reason for optimism:

• Six months after injection, seven top-tier responders reported an increase in hair density of more than 10 percent.
• At 24 months, the average hair density increase for these same seven participants was 8.3 percent.
• For three of the top seven trial participants, the increase at 24 months remained above 10 percent.
• The largest increase in hair density observed in this group was a 21 percent increase at 24 months.

Despite those relatively lackluster numbers, RepliCel’s enthusiasm for RCH-01 certainly isn’t dampened. The company reports it continues to refine the way it harvests and cultures DSCC to achieve better results. The theory is that long-term survival of injected cells can be improved with smaller dose size and multiple sessions of injections – rather than doing it all at once as they did in the first phase 1 safety trial. Therefore, in the next phase, researchers plan to deliver smaller doses more frequently, expecting that doing so will lead to more predictable and improved patient outcomes.

“Our aim is to revolutionize the way we prevent, treat and even reverse hair loss,” said President and CEO R. Lee Buckler.

Now that RCH-01 has cleared this first hurdle, there will be at least two next steps to watch for. First, researchers at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, are overseeing a clinical trial involving 60 men and women with thinning hair. That study is being financed by Shiseido Company and initial results could be released as early as 2018. Second, RepliCel has announced a larger Phase 2 study of 160 healthy men with mild-to-moderate pattern baldness.

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