Cellular Dynamics International (CDI), a FUJIFILM company, announced a new venture named Opsis Therapeutics. Formed on July 31, Opsis Therapeutics is pioneering new approaches to treating retinal diseases and developing a pipeline of therapeutic candidates. The company will bring together a cross-disciplinary team with expertise in iPSC manufacture, iPSC differentiation into retinal lineages, retinal cell biology, preclinical modeling of retinal disease, and sub-retinal surgery. The venture has been founded in partnership with David Gamm, M.D., Ph.D., a world leader and pioneer in the differentiation and transplantation of iPSC-derived retinal cells.

Implications of Genomic Instability in Human Pluripotent Stem Cells
It has been widely reported that human pluripotent stem cells (hPSCs) can become karyotypically unstable during their prolonged culture in vitro. These cytogenetic changes bear stark similarities to those found in many human cancers raising safety concerns for their potential use in regenerative medicine. Although the mechanisms behind these changes are still to be elucidated, they have been shown to provide variant cells with a selective advantage and rapidly out-compete normal cells in culture. As the first clinical trials using hPSC-derived cells are underway, it is imperative that we understand the implications of these changes and how to detect and minimize their occurrence in hPSC cultures.

FDA Approves the Cleveland Cord Blood Center’s CLEVECORD™ for Stem Cell Transplants
The U.S. FDA has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for CLEVECORD™, a stem cell product (HPC, Cord Blood) derived from umbilical cord blood. Under this license, CCBC is authorized to manufacture CLEVECORD for use in unrelated hematopoietic cell transplantation in patients with disorders affecting the hematopoietic system, such as leukemia, lymphoma and immune system disorders. Launched in 2008, the CCBC collects, processes, stores, and distributes umbilical cord blood-derived stem cell units for use in hematopoietic progenitor cell therapy and cellular therapy research.

In 2006, Shinya Yamanaka and Kazutoshi Takahashi reported the Nobel Prize winning discovery of induced pluripotent stem cells (iPSCs) in Cell. Over the past 10 years, iPSC technology provided fundamental insights into our understanding of cell fate, mammalian development, and human disease. To celebrate the decade that has passed since the landmark discovery of induced pluripotent stem cells, Cell Press hosted “10 Years of iPSCs,” a symposium focused on iPSC research and applications. Because of the historic significance of the conference, BioInformant was a proud sponsor and attendee of the 2016 event.

U.S. FDA Holds Historic Public Hearing – Key Points of Agreement and Contention for Regulation of Stem Cells
On September 12-13th, 2016, the FDA hosted a public hearing to review draft guidances pertaining to the regulation of human cell and tissue-based products (HCT/Ps). The event was widely attended by representatives from across the cell therapy industry, with nearly 500 of individuals attending the event and thousands more watching the live stream. Over two marathon days, presenters gave a range of different perspectives as to how the FDA should regulate these human products. While all were in agreement that the FDA needs to foster innovation while protecting patients, contention emerged when the technicalities of how to accomplish this goal were discussed.

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