RepliCel Reveals Clinical Data Proving the Safety of Its Patented Natural Hair Cell Replication Technology
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, initiates natural hair regeneration.
According to RepliCel Life Sciences, the technology has the potential to become the world's first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women.
Earlier this year, RepliCel revealed 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.
Presenting the details of the new clinical data of the study, David Hall, RepliCel's President and CEO, said, "As previously reported, a 6-month interim analysis of data from RepliCel's first-in-man clinical trial revealed that the RepliCel treatment is safe and effective. This news is significant, as it allows us to move forward with our Phase II dosing trial."
Hall further said the company’s team is working with European regulators to finalize protocols for the Phase IIb clinical trial application, expected to commence in late 2012.
The Phase IIb trial is 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.
Phase IIb clinical trial will focus on optimizing treatment regimen for hair growth. Several different treatment regimens will be tested, including different concentrations of cells and different treatment schedules, including single and repeat injections.
Further, RepliCel Life Sciences is also planning to optimize the procedure to enhance cell yield and isolation from scalp biopsies and improving cell replication yield and processing time.
The company’s efforts to advance the RepliCel natural hair cell replication technology have born fruits. Till date, it has raised over USD$2.8 million through a series of private placements. These funds will be used for the continued advancement of the RepliCel technology, company officials said.
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