ISSCR News
The ISSCR Shared Comments on Hong Kong’s Draft Guidance for Cell and Tissue Products
The ISSCR condemns the premature commercialization of unproven cell therapies, which has resulted in patients being blinded, paralyzed, and infected with dangerous pathogens. In many countries, unscrupulous businesses marketing these unproven cell therapies have abused ambiguous definitions for substantial/minimal manipulation and homologous use to claim they are not subject to oversight. Regulators around the world need to adopt harmonized product definitions to protect public health and to prevent the premature commercialization of stem cell-based products.
The ISSCR Signs Ad Hoc Group for Medical Research Coalition Letter on NIH to President-elect Biden
The ISSCR joined with the Ad Hoc Group for Medical Research and 349 member organizations representing patients, clinicians, scientists, educators, academic institutions, research organizations, and industry, in a letter thanking President-elect Joseph R. Biden, Jr. for his steadfast support for science. The letter states, "As the oldest coalition advocating for the federal investment in the National Institutes of Health (NIH) and biomedical, bioengineering, behavioral, and social science research, we are grateful that you support increased and sustainable funding growth for the NIH as part of $300 billion in new research and development investments in your Build Back Better plan."
The ISSCR Shares Comments on the European Medicines Agency's Network Strategy to 2025
The ISSCR shared comments with the European Medicines Agency (EMA) related to its Network Strategy 2025. This included support for the crucial role of EMA and national regulators in overseeing the development of new products and offer a few recommendations to ensure that new products are proven safe and effective before being marketed to patients.
ISSCR Applauds Australia’s Move to Regulate Autologous Human Cell and Tissue Products
The ISSCR appreciates the new framework proposed by Australia’s Therapeutic Goods Administration (TGA) for the regulation of human cell and tissue products that use a person’s own cells (‘autologous use’). These new regulations are meant to halt the marketing and administration of unproven cell therapies that have not been proven safe or effective. Sales of these products by unscrupulous clinics to desperate patients have been increasing in recent years. Recently, these products resulted in the death of an Australian patient and the blinding of three patients in the United States.
ISSCR Advocates for Stem Cells and Basic Research in Europe
The ISSCR met 11 April with the European Parliament’s Committee on Industry, Research and Energy to advocate for investments in basic research in the European Union’s 9th Framework Programme for Research and Innovation. ISSCR members Pete Coffey and Michele De Luca, along with ISSCR Policy Director Eric Anthony, described the need for continued investments in basic research to improve understanding of human physiology and develop new approaches to treat disease.
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