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.
Categories: Hair Cloning, Hair Loss
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