Aug 18, 2014
Image courtesy of Dr Kristen Brennand & Dr Fred H. Gage/ Salk Institute for Biological Studies
Image courtesy of Dr Yichen Shi and Dr Rick Livesey/ Cambridge Stem Cell Institute
Aug 18, 2014
Authors: Ogbogu U, Toews M, Ollenberger A, Borry P, Nobile H, Bergmann M, Caulfield T.
Biobanks are an important research resource that provides researchers with biological samples, tools and data, but have also been associated with a range of ethical, legal and policy issues and concerns. Although there have been studies examining the views of different stakeholders, such as donors, researchers and the general public, the media portrayal of biobanks has been absent from this body of research. This study therefore examines how biobanking has been represented in major print newspapers from Australia, Canada, the United Kingdom and the United States to identify the issues and concerns surrounding biobanks that have featured most prominently in the print media discourse.
Part of this work is supported by the EUCelLEX project.
End of June, Cellectis received a Scientific recommendation from the European Medicines Agency (EMA), in consultation with the European Commission, for UCART19, its lead product candidate in adoptive immunotherapy against CD19 expressing leukemias and lymphomas.
The company is expert in the development of innovative cancer products based on engineered T cells armed with a Chimeric Antigen Receptor (CAR). Cellectis’ state-of-the-art genome engineering technologies take T cell CAR technologies to the next level. An engineered T cell can in particular be converted into an allogeneic product or resist existing cancer treatments, or it can overcome checkpoint inhibition. Cellectis is focusing on certain types of cancers, particularly leukemia (B cells malignancies) and solid tumors (12 antigenic targets).
UCART19 fulfills the definition of an Advanced-Therapy medicinal Product (ATmP) being eligible for Scientific Advices and Assessment from the EMA Committee for Advanced Therapies (CAT) as well as for European centralized Marketing Authorization Approval. The EMA/CAT considers that Cellectis’ allogeneic engineered Chimeric Antigen Receptor (CAR+) T-cells fall within the definition of a Gene Therapy Medicinal Product. Furthermore, Cellectis qualifies for the incentives available to Small and Medium size Enterprises (SME) developing ATmP.
Last Friday, Cellectis announced the sale of its Swedish subsidiary Cellectis AB to the Japanese Company Takara Bio Inc. This decision is part of the strategy of the biotech group to focus on the field of oncology. Cellectis AB is specialized in the development of embryonic stem cells to the industry and the research community.
Find the Press Release here
A properly reasoned refusal by the courts to authorise access to experimental treatment was neither arbitrary nor discriminatory
Jun 2, 2014
In its decision in the case of Durisotto v. Italy (application no. 62804/13) the European Court of Human Rights has by a majority declared the application inadmissible.
The case concerned the refusal by the courts to authorise the applicant’s daughter to undergo compassionate therapy (experimental treatment known as the “Stamina” method) to treat her degenerative cerebral illness. The therapy was undergoing clinical trials and, under a legislative decree, was subjected to restrictive access criteria.
The Court held that the prohibition on access to this therapy, imposed by the court in application of legislative decree no. 24/2013, pursued the legitimate aim of protecting health and was proportionate to that aim. Sufficient reasons had been given for the court’s decision, and it had not been arbitrary. Indeed, the therapeutic value of the “Stamina” method had, to date, not yet been proven scientifically. Nor could the Court conclude that the justice system’s refusal to grant her permission had been discriminatory.
The decision is final.
Find the Press Release here
Apr 30, 2014
AUTHORS : Mitsutoshi Yamada, Bjarki Johannesson, Ido Sagi, Lisa Cole Burnett, Daniel H. Kort, Robert W. Prosser, Daniel Paull, Michael W. Nestor, Matthew Freeby, Ellen Greenberg, Robin S. Goland, Rudolph L. Leibel, Susan L. Solomon, Nissim Benvenisty, Mark V. Sauer & Dieter Egli.
The transfer of somatic cell nuclei into oocytes can give rise to pluripotent stem cells that are consistently equivalent to embryonic stem cells, holding promise for autologous cell replacement therapy. Although methods to induce pluripotent stem cells from somatic cells by transcription factors are widely used in basic research, numerous differences between induced pluripotent stem cells and embryonic stem cells have been reported, potentially affecting their clinical use. Because of the therapeutic potential of diploid embryonic stem-cell lines derived from adult cells of diseased human subjects, we have systematically investigated the parameters affecting efficiency of blastocyst development and stem-cell derivation. Here we show that improvements to the oocyte activation protocol, including the use of both kinase and translation inhibitors, and cell culture in the presence of histone deacetylase inhibitors, promote development to the blastocyst stage. Developmental efficiency varied between oocyte donors, and was inversely related to the number of days of hormonal stimulation required for oocyte maturation, whereas the daily dose of gonadotropin or the total number of metaphase II oocytes retrieved did not affect developmental outcome. Because the use of concentrated Sendai virus for cell fusion induced an increase in intracellular calcium concentration, causing premature oocyte activation, we used diluted Sendai virus in calcium-free medium. Using this modified nuclear transfer protocol, we derived diploid pluripotent stem-cell lines from somatic cells of a newborn and, for the first time, an adult, a female with type 1 diabetes.