Regenerative Medicine News

ACF Bioservices has emerged as a leader in developing quantitative cell-based in vitro potency assays to support FDA-mandated product release requirements. These potency assays range from relatively simple protocols to more complex and elaborate designs that determine the mechanism of action of a gene therapy product.
The new technology uses simple total cell count data from serially passaged cell cultures to decipher, for the first time, the specific number and functions of tissue stem cells in complex preparations like experimental or treatment samples. The desired data is extracted with proprietary computer simulation software developed with partner AlphaSTAR Corporation.
July 31, 2017 – (BioLife) – BioLife Solutions, Inc. announced it has executed a long term supply agreement with NASDAQ-listed Celyad, a leader in the discovery and development of CAR-T cell therapies. BioLife's CryoStor clinical grade cell freeze media is incorporated into Celyad's manufacturing process for its Natural Killer Receptor based T-Cell (NKR-T) platform. 
July 13, 2017 – (Novartis) – "The panel's unanimous recommendation in favor of CTL019 moves us closer to potentially delivering the first-ever commercially approved CAR-T cell therapy to patients in need," said Bruno Strigini, CEO, Novartis Oncology. "We're very proud to be expanding new frontiers in cancer treatment by advancing immunocellular therapy for children and young adults with r/r B-cell ALL and other critically ill patients who have limited options. We look forward to working with the FDA as they complete their review." 
July 12, 2017 – (Cambridge Stem Cell Institute) – Scientists at the Cambridge Stem Cell Institute and the Sanger Institute have developed a new method for growing and transplanting artificial bile ducts that could in future be used to help treat liver disease in children, reducing the need for liver transplantation. 
July 12, 2017 – (Straits Times) – The use of stem cells to reverse liver cirrhosis - or the hardening of the liver - is being explored in a clinical trial. Conducted by a multi-centre team led by the National University Hospital (NUH), doctors aim to determine if stem cell therapy can improve liver function. 
July 12, 2017 – (Korea Herald) – South Korean regulators approved Wednesday the country’s first-ever cell-mediated gene therapy for degenerative arthritis Invossa, developed by US-based TissueGene, a wholly-owned subsidiary of Korea’s Kolon Group. Korea’s Ministry of Food and Drug Safety has granted approval to Invossa-K Inj., an injectable cell gene therapy for osteoarthritis, a joint disease common among the elderly in which the cartilage that cushions the ends of bones between joints breaks down. 

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