Category: Cell and Tissue Bank

EMA warns against using unproven cell-based therapies

EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based therapies which may not be safe or effective.

The CAT’s advice is in response to individuals, companies and hospitals promoting unproven cell-based therapies as cures for a broad range of conditions including cancer, cardiovascular diseases, autism, cerebral palsy, muscular dystrophy and vision loss. These treatments can pose serious risks to patients for little or no benefit.Patients using unproven or unregulated cell-based therapies have reportedly suffered serious, sometimes fatal, side effects including infections, unwanted immune reactions, tumour formation, loss of vision and bleeding in the brain.

Cell-based therapies are treatments using cells from the patient or a donor. The use of blood and cells for transplantation is a well-established medical practice. However, if cells are not used for the same essential function in the recipient as in the donor or if they are being substantially manipulated, they are not considered transplants and their safety and benefits cannot be assumed. For this reason, suchtherapies are regulated in the EU as medicinal products.

More: https://www.ema.europa.eu/en/documents/public-statement/ema-warns-against-using-unproven-cell-based-therapies_en.pdf

Public Stem Cell Bank

Public Stem Cell Bank at Regional Science-Technology Centre in Podzamcze was launched on November 4th. The Bank was established as a result of the project within the framework of the Regional Operational Programme 2007-2013 for Świętokrzyskie region. Public Stem Cell Bank in Podzamcze joined the elite group of five other public banks of umbilical cord blood in Poland. BMCT held patronage over the press conference promoting the project.

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MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

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