New guidance on stem cell therapies
Stem cell medicines are produced in large batches which need to be sterile.
The first ever guidance for stem cell-based therapies in animals has been-been published by the European Medicines Agency (EMA).
The guidance follows a review of scientific evidence by the Committee for Medicinal Products for Veterinary Use (CVMP), which identified the sterility of stem-cell therapies as a ‘priority area’.
Taking the form of a question and answer document, the guidance addresses eight main concerns raised by manufacturers and authorities with regards to ensuring sterile and safe stem cell-based therapies.
Veterinary stem cell medicines originate from tissues from a donor from the same species of animal. They are produced in large batches which need to be sterile as they are administered by injection into the body.
Contamination can occur at various stages - from the initial sampling of cells and tissues, up to the final packaging into vials, syringes or bottles. The EMA states that the most critical step is the sourcing and collection of the stem cells as it is not always possible to put in place aseptic techniques at this stage.
Up to now, there has been no specific guidance from the EMA on how stem cell-based veterinary medicine should be used. Guidance documents have been produced for human cell-based products or for general requirements on animal cell-based products in the USA.
In recent years, interest and research into new therapies such as stem cell or gene therapy has gathered speed. In 2014, the EMA established an Ad Hoc expert group of veterinary novel therapies to provide general guidance on the requirements of novel veterinary medicines.
The EMA defines novel therapies as therapies that are entirely new to the veterinary sector. This is because they are genuinely new and have not been used in animals before, or new only to the veterinary sphere, but well known in human medicine.
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