Cell therapy weekly: Bioethical framework for therapeutic gene editing released
Content matching 'cell therapy approval'
German-based trial to test RCS-01 cell therapy treatment for aged and sun-damaged skin
Cell therapy weekly: FDA indicates more guidance is to come on cell therapy manufacture
Cell therapy weekly: Positive results from regenerative tissue clinical trial for deep, partial-thickness thermal burns
RepliCel Life Sciences has received approval to conduct a phase 1 trial in healthy volunteers investigating the potential of its skin rejuvenation product, RCS-01, to treat intrinsic aging of the skin, skin wrinkling and solar degeneration of the skin. RepliCel’s non-bulbar dermal sheath-derived fibroblast therapy (RCS-01) provides a promising treatment for these conditions by providing UV-naïve collagen-producing cells directly to affected areas. RepliCel’s unique manufacturing technology allows for isolation of fibroblasts derived from anagen-hair follicle mesenchymal tissue, which elicit efficient replication potential in culture. Furthermore, the proprietary culture conditions in which RCS-01 is manufactured should enable these cells to maintain their inherent ability to adapt to their microenvironment and respond to the surrounding stimuli after injection, leading to robust, natural production of type 1 collagen, elastin and other extracellular proteins within the tissue. The goal is to develop a first-of-its-kind treatment for fine wrinkles on sun-damaged skin.
Latest developments compiled from 01 – 31 December 2014
Latest developments compiled from 1 October until 30 November 2014
Supporting the FDA’s tougher stance on unproven cell therapies: an interview with Massimo Dominici
It makes no sense to look at stem cell companies differently from drug or biologics companies. The technology may be different, but the diseases they seek to treat are the same. In fact, cell therapies may ultimately be more useful and more curative than drugs, and hence more valuable. That's the way Alain Vertès of NxR Biotechnologies sees it. In this interview with The Life Sciences Report, Vertès talks about some of the stem cell names he knows well, and draws comparisons investors can bank on.
Understanding Good Manufacturing Practice and how Biological Industries can support cell therapy development