Status of equine stem cell-based veterinary medicine in the UK.

The research article discusses the current state of stem cell-based veterinary medicines for horses in the UK, highlighting two such medicines, Arti Cell Forte and HorStem, that have recently been granted EU-wide marketing authorization. It also explains the regulations around these medicines, the need for marketing authorization, and the role of the Veterinary Medicines Directorate (VMD) and Equine Stem Cell Centre Authorization (ESCCA) in their oversight.

Arti Cell Forte and HorStem

• The research highlights two stem cell-based veterinary medicines, Arti Cell Forte and HorStem, which are the first such medicines granted EU-wide marketing authorization.
• Arti Cell Forte is used to address mild to moderate recurrent lameness related to non-septic joint inflammation in horses.
• HorStem is used to reduce lameness resulting from mild to moderate degenerative joint disease (osteoarthritis) in horses.

Regulations for Stem Cell-Based Medicines

• These medicines are composed of allogeneic stem cells and have undergone a rigorous scientific assessment to ensure they are safe, effective, and meet specified quality standards.
• Allogeneic and xenogeneic stem cell-based medicines require marketing authorization before they can be placed on the UK market.
• Historically, stem cell-based veterinary medicines have been available in the UK from stem cell centres granted ESCCA authorization by the VMD.

Role of the VMD and ESCCA

• ESCCAs ensure that the stem cell centre meets satisfactory manufacturing standards, the collection of stem cells respects animal welfare, the stem cells are collected under the responsibility of a vet, and the stem cell centre is supervised by a qualified person.
• However, products produced by an ESCCA holder are not authorised medicines, as they haven’t been assessed by the VMD for their quality, safety, and efficacy.
• Such products can only be administered by a vet under their direct responsibility and cannot be advertised, though ESCCA holders can promote their stem cell services directly to vets without making medicinal claims or references to specific diseases.

Prescribing Cascade

• The Veterinary Medicines Regulations prohibit the administration of unauthorized veterinary medicines unless their use is justified under the prescribing cascade.
• When a clinically suitable veterinary medicine for a specific condition isn’t available in the UK, the prescribing cascade allows vets to use their clinical judgement in treating the animals under their care.
• In these circumstances, the cascade provides a framework for vets to prescribe unauthorised products to prevent unacceptable suffering, but the vet should first consider the clinical suitability of available authorized stem cell-based products and other authorized veterinary medicines.