RepliCel's First-in-Man Clinical Trial Reveals Double Digit Hair Growth
Recently RepliCel announced the results of its first-in-man clinical trial of the hair cell replication technology. The results revealed that the technology can result in substantial hair growth with seven participants demonstrating double digit hair growth without any negative health effects.
The top three participants in terms of the best results reported 17.2 percent, 19.2 percent and 19.6 percent hair growth following the clinical trial. RepliCel is based on autologous cell implantation technology. According to the company, RepliCel technology replicates a patient's hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, it initiates natural hair regeneration. The technology has won patents from the European Union and Australia while it is pending with other major international jurisdictions.
"The RepliCel TS001-2009 trial was a first-in-man trial with a primary endpoint of safety and this was confirmed emphatically," said Dr. Rolf Hoffmann, chief medical officer at RepliCel. "Even though the size of the trial was only powered for safety measures, secondary endpoints were included in interim analysis to give us an early look at efficacy to allow us to better drive the design of the next steps of the clinical development of the RepliCel procedure."
Nearly 63 percent of the subjects had an increase in hair density of more than 5 percent (vs. control) at six months post injection though some subjects had not yet shown an increase at this time point. There were changes in baseline by as much as 19.6 percent in some of them, while others showed decreases of as much as 6.2 percent. The overall average was 6.2 percent.
Darrell Panich, vice-president of Clinical Affairs at RepliCel, said, "A negative measurement from baseline at six months is not unexpected as many hair fibers in the area of injection typically fall out from trauma; not unlike hair transplant surgery. Further analysis of the data we collected from our small, first-in-man trial will help us characterize the many factors that determine an individual's response to treatment with injected autologous Dermal Sheath Cup Cells (DSCC) which will lead to an improved treatment regimen." The company is currently conducting an in-depth analysis of the interim data collected during the TS001-2009 clinical trial to identify factors that may impact the efficacy DSCC. By cross-referencing the subject-response data collected by the primary investigator against other measured variables and against results
from histopathological analysis of biopsies collected from treatment zones, the company will derive improved understanding of the factors that impact the efficacy of the technology.
RepliCel has also scheduled the next (Phase IIb) trial designed as a dose-finding study which will assess the number of characterized cells and the appropriate treatment pattern necessary to promote optimal hair growth. The study will include multiple subject cohorts studying different doses of DSCC.
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