Saturday 7 January 2012

RepliCel Update on First-In-Human Clinical Trial

RepliCel Life Sciences is pleased to provide an update on its
first-in-human clinical trial TS001-2009. As of today, all 20
subjects have been enrolled in the study and have provided biopsy
samples for processing using the proprietary RepliCel? technology.
Furthermore, the first injection of hair follicle cells prepared
using RepliCel? technology was completed on March 10, 2011. The
final injections of hair follicle cells are anticipated to take
place before the end of July 2011. The first injection of hair
follicle cells represented the beginning of the next stage of the
TS001-2009 study. In this stage, the post-injection follow-up
period, subjects return to the study centre to have their health
closely monitored to ensure that there have been no adverse effects
associated with receiving the injections and to determine the hair
growth stimulating efficacy of the hair follicle cell injections.
All subjects are expected to complete their six-month follow-up
visit by the end of January 2012. Once the final patient has
completed their six-month follow-up visit, an interim analysis of
all collected data will be performed to assess the primary outcome
measure of the TS001-2009 study. The analysis will involve
assessment of the local (at treatment sites) safety profile of
autologous hair follicle cells compared to placebo as defined by
adverse events (AEs) with respect to their causality, incidence,
severity and seriousness.

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