The regenerative medicine company, Replicel Life Sciences Inc. has partnered with Japanese cosmetics and skincare giant Shiseido, and has managed to successfully complete the first phase of its human clinical trials. The research involves stem cell therapy to treat androgenetic alopecia, also known as pattern baldness which affects both men and women.
This successful first phase means that Replicel Life Sciences can now begin to develop its product, currently referred to as RCH-01 which is thought to be able to revolutionise the way that hair loss can be prevented, treated and in some cases even reversed.
About the study
The study took place over the span of five years and measured local and systematic tolerance of participants, and evaluated any side effects. Fortunately, no serious adverse effects were reported and participants only complained of minor scalp irritations during the administration of local injections.
The irritations quickly resolved within a few minutes after the injection, and further histopathological evaluations at the injection site did not find any suggestions of pathology or even foreign body formation. Therefore long term safety has been confirmed with the trial.
Currently, the trials have found more than a 10% increase of hair density within six months of injections. By the second year, participant’s hair density had become steady at 8.3%, yet some participants maintained more than 10% hair density. Although there was a high degree of variability amongst the participants, all participants’ hair loss had reduced and become stabilised.
What is the next stage?
The next phase of this cell therapy trial will enrol 160 men who have mild to moderate androgenetic alopecia. Dermal sheath cup cells will be extracted from a small biopsy which will be taken from the back of the participants scalp; these cells will be replicated and then reintroduced by injection into the balding areas of the participants scalps.
The participants will remain part of the trail for 39 months and will be required to return to the clinic so that total hair density and cumulative thickness of the hair can be assessed alongside further long term safety issues.