RepliCel Update on First-In-Human Clinical Trial TS001-2009
May 2011
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.
Secondary outcome measures of systemic (overall) safety (through review of adverse events in a similar fashion as described above) and efficacy (hair growth at treatment sites) will also be performed at this time.
Data from the interim analysis should be available
for review in early 2012. Subjects will participate in the follow-up
period of the study until July 2013 and final analysis of data
should be available in Q3 2013.
TS001-2009 Clinical Trial Overview
The TS001-2009 clinical trial is designed to test the safety and
efficacy of the RepliCel? technology in men and women with
androgenetic alopecia. This single-centre study enrolled 20 subjects
with alopecia categorized as either vertex pattern type II or type
III on the Ludwig Scale (female) or as type III vertex to type VI on
the Norwood Scale (male).
At the beginning of the trial, subjects provided blood samples to confirm their health status and biopsies were taken from their scalps from which hair follicle cells were/are being processed using RepliCel? technology.
Once cell processing is
complete, subjects return to the study centre to have baseline
measurements of their overall health and the health of their scalps.
They then receive injections of their own replicated cells (autologous
cells) in medium (verum) and medium alone (placebo) into two
pre-selected treatment areas in their scalps.
In the follow-up period, subjects return to the clinic for 10 visits
over the next 24 months. At these visits, subjects have their
overall health assessed, as well as subjective and objective
assessments of the areas that were injected either with verum or
placebo. Digital images will be taken of the scalp to assess any
changes to the scalp post-injection and the differences in health
and hair growth between the two treatment areas.
Furthermore at 6,
12, and 24 months post-injection, four subjects at each time point
will provide biopsies of the injection sites for histopathological
analysis. The total duration of subject participation in the study
is approximately 27 months.
About RepliCel Life Sciences
To properly reflect the Company's business focus, Newcastle
Resources Ltd. is doing business as RepliCel Life Sciences. The
Company has developed RepliCel?, a natural hair cell replication
technology that has the potential to become the world's first,
minimally invasive solution for androgenetic alopecia (pattern
baldness) and general hair loss in men and women.
RepliCel? is based on autologous cell implantation technology that replicates a patient's hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, the Company hopes to initiate natural hair regeneration. Patents for the technology have been issued by the European Union and Australia and are pending in other major international jurisdictions.
The RepliCel? procedure has been
developed over the past nine years by the Company's recognized
research scientists and medical experts - specialists in the fields
of hair growth, hair biology and dermatology. Additional information
on RepliCel is available at www.replicel.com.
Source
.gif)
