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ISCT is pleased to announce the 2021 Impact Factor for CYTOTHERAPY ® . Thank you to all those that have contributed to the continued growth of the Society's peer reviewed journal. PUBLISH WITH CYTOTHERAPY ...
Hemophilia is a disorder in which a person’s blood does not clot normally, which can lead to spontaneous or excessive bleeding, according to the Centers for Disease Control and Prevention (CDC). [1] Despite advancements in the treatment of hemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release “Today’s approval provides a new treatment option for patients with hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia,” he said. [2] Clinical trial data suggest that a single dose of Hemgenix will provide patient with moderate to severe hemophilia with adequate protection from uncontrolled bleeding for eight years, and potentially longer
ISCT is pleased to announce the release of our 2021 ISCT Annual Report: Sustaining Connections in CGT
Patients with haemophilia B have mutations (changes) in a gene which the body needs to make the clotting protein Factor IX, resulting in either a partial or complete lack of its activity [1] Hemigenix received FDA BLA approval on 22 November 2022 [4, 5]. As of 22 March 2023, Hemgenix has not yet been approved by the TGA, but it was granted orphan designation by the TGA in August 2022 [6]
Read the full press release here #News
In the light of the unfolding COVID-19 pandemic, there is urgent need for new therapies, particularly for critically ill patients. As legitimate clinical investigations, such as SARS-COV-2 vaccine clinical trials, ramp up, there has been a proliferation of unproven and untested interventions,...
ISCT EU Legal and Regulatory Affairs (LRA) Update On July 11, the FDA released a total of 6 guidance documents intended to help advance the field of gene therapy
ISCT North America Legal & Regulatory Affairs (NA LRA) Committee Releases Two Review Publications on the Current State of US FDA and Health Canada Regulation for Cell & Gene Therapy Products A major hurdle for worldwide development of Cellular & Gene Therapy Products (CGT) is the differing regulatory structures within various geographic jurisdictions
Genetically modified pig heart transplanted into a human On 22 September 2023, it was announced that the world’s second patient had undergone xenotransplantation, at the University of Maryland Medical Center (UMMC), with a genetically modified pig heart
Preclinical studies have demonstrated that MPCs and mesenchymal stem cells (MSCs) reduce macrophage-dependent inflammation and also release angiogenic factors in regions of ischemia to improve microvascular function