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Nanomedicine is an emerging field that utilizes nanotechnology concepts for advanced therapy and diagnostics.
We review current clinical and preclinical studies for advanced therapy cartilage regeneration and evaluate the progress of the field.
Since the implementation of the European Union (EU) regulation for advanced therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing authorization approval in the EU.
Numerous stem cell phase I/II clinical trials showing safety and efficacy will soon pursue qualifying criteria for advanced therapy medicinal products (ATMP), aspiring to join the first stem-cell therapy approved by the European Medicines Agency.
These biologically-derived products create new challenges for the assessment and market approval of medicinal products, which is why particular categories of these products (e.g. gene therapy, cell therapy, and tissue engineering) have been brought into Europe under a special regulatory regime for advanced therapy medicinal products (ATMPs).
Failure was defined as a need for advanced therapy.
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Technological resources are available for large-scale cell encapsulation intended for advanced therapies (gene therapy, somatic cell therapy and tissue engineering) in a cell factory, following GMP guidelines.
This includes optimization of advanced heart failure medical management, use of cardiopulmonary exercise testing to determine prognosis, and evaluation for advanced therapies such as short-term and long-term mechanical support platforms and cardiac transplantation.
The commonly used practice of relying on clinical findings and noncontrast head CT for management decisions may provide inadequate information for triaging stroke patients for advanced therapies.
High levels of bio-ADM at 48 h or later may reflect a state of refractory shock with end-organ damage, despite normalization of lactate levels, and may help the clinician in a more accurate patient selection for advanced therapies, or guide in the difficult process of limiting the therapeutic effort.
Mr President, honourable Members, I am very glad that we are able today to talk about the regulation on medicinal products for advanced therapies, which has been long awaited, and is of enormous importance to innumerable sick people in Europe, to many of whom these new therapies offer hope of new and life-saving treatment.
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