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RepliCel Announces Two Approvals Necessary for RCS-01 Human Clinical Trial
Jul. 21, 2015 11:12AM PST
Longevity InvestingRepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) announced that it has received approval from the Ethics Committee of the Faculty of Medicine Heinrich-Heine Universität Duesseldorf and from the Leibniz-Institut for its Tissue Procurement Authorization (TPA) to conduct a RCS-01 phase 1 human clinical trial. RCS-01 is cell therapy treatment for aged and sun-damaged skin.
RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) announced that it has received approval from the Ethics Committee of the Faculty of Medicine Heinrich-Heine Universität Duesseldorf and from the Leibniz-Institut for its Tissue Procurement Authorization (TPA) to conduct a RCS-01 phase 1 human clinical trial. RCS-01 is cell therapy treatment for aged and sun-damaged skin.
According to the press release:
Ethics Committee approval and TPA are two parts of a three-part Clinical Trial Application (CTA) approval process required to conduct human clinical trials in Germany. The final approval required is from the Paul Ehrlich Institute (PEI), the German regulatory body. If cleared to proceed, the proposed trial will be conducted at the IUF Leibniz-Institut für umweltmedizinische Forschung GmbH in Germany.
Dr. Rolf Hoffman, Chief Medical Officer, comments:
The market for dermal fillers currently represented almost 6 million procedures and expenditures of almost $2 billion in 2013 according to statistics provided by the American Society of Plastic Surgeons. RCS-01 could disrupt this market by providing patients with a filler comprised of their own fibroblast cells – a much more compelling long-term solution than hyaluronic acid which dissipates in approximately six months.