RepliCel Life Sciences Inc. announced February 5th that it is negotiating with German government officials for its upcoming Phase II clinical trial for its hair multiplication product, known as RCH-0, at the Paul Ehrlich Institute (PEI), a medical regulatory agency located in Langen, Germany.
The clinical trial will test the effectiveness of RCH-01 in more than 100 male volunteers suffering from various stages of hair loss. The purpose of the clinical trial is to further test the safety of RCH-01 injections as well as to determine the optimal protocol for the treatment to increase hair growth.
Hair Loss Products That Grow New Hair
“We are happy with the progress made with the design of our upcoming Phase II trial and are quite eager to get input from the PEI that will allow us to conduct the best clinical trial for the development of our product,” said Darrell Panich, Replicel’s vice president of clinical affairs. “Designing a trial in consultation with the PEI will facilitate the completion of the formal clinical trial application for our upcoming trial.”
Replicel is has developed what is says is a natural hair cell replication technology that, it claims, has the potential to become the world’s first “minimally invasive solution” for androgenetic alopecia (pattern baldness) and general hair loss in both men and women. The technology involves removing hair follicles from a patient’s scalp, reproducing them in a laboratory, and then re-injecting them into various sites on the scalp – much like “re-seeding” a lawn. This hair cell replication technology would overcome one of the principal obstacles for surgical hair restoration: the lack of a sufficient amount of donor hair on many patients for a cosmetically satisfying result. The RepliCel technology, if it works, would provide what its supporters hope will be a virtually limitless amount of donor follicles for “re-seeding.”
The Phase II clinical trial represents a significant advance in the research. In the Phase I clinical trial, the company produced only 16 “data points.” The Phase II trial aims at 288, enough to determine the optimal type and amount of injections for treating hair loss.
The Vancouver, B.C.-based company says it has won patents for its technology from both the European Union and Australia and that patents are currently pending in other jurisdictions.
“The Company has made significant advancements in its manufacturing procedures and these improvements are expected to have a meaningful impact on our RCH-01 program,” said Replicel CEO David Hall, in a written statement released in early February. “We are committed to receiving guidance and implementing the recommendations provided by the regulatory authorities to ensure we have a well-constructed Phase II trial that will lead to the optimum dose to treat pattern baldness.”
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