GST Boehringer Ingelheim

Policy on animal welfare and use of animals in research

The main goal of Global Stem cell Technology is to improve the health of animals that have serious and debilitating diseases, with an emphasis on ameliorating their quality of life. Driven to find more new treatments and cures, we develop innovative stem cell-based therapies with validated safety and efficacy. As part of this validation, regulatory authorities approve all our research and clinical trials that use animals (Directive 2001/82/EC).

In Europe, 1.4 million horses suffer from tendon injuries, 15 million dogs have osteoarthritis and there is currently no effective treatment for it.

In 2019, the European Medicines Agency approved Arti-Cell Forte. This is the first of two stem cell products for horses with a marketing authorization. Other stem cell treatments are circulating, but they have not gone through legal procedures to prove their safety and efficacy.

At Global Stem cell Technology, we consider animal welfare and the humane use and care of animals a top priority. All studies and research involving animals is performed in compliance with Directive 2010/63/EU, local and national regulations and laws. The staff involved with the use and care of animals are qualified, trained and/or educated to do so, ensuring a high quality of animal welfare and scientific data. We strive to exceed mandatory requirements on animal welfare and uphold high animal care standards, as we solemnly believe this is our duty to the animals that help us develop innovative products and provide durable solutions for a vast amount of diseased patients.

As a recognized research facility, Global Sem cell Technology receives regular inspections - also unannounced - to verify the safety and welfare of the animals. We have a veterinarian who closely monitors the welfare of all animals every day and an animal welfare expert who inspects every three months.

Global Stem cell Technology also commits to being open and transparent and applies the established  principles of the 3Rs (Replace, Reduce, Refine) concerning the use of animals in research. This means:

·        We Replace animals in our studies and trials wherever possible by using alternative methods. We invest in research for animal-free methods and consult with competent regulatory authorities on acceptance of our proposed alternatives. Because of the complexity of the animal physiology however, some efficacy and safety measurements cannot be performed without the use of animals.

·        We Reduce the number of animals needed for a study so the maximum information is obtained with the lowest possible impact on animal welfare. To achieve this, each study design is carefully reviewed by regulatory experts and an ethics committee. Additionally, advice of regulatory instances is gained on the acceptance of using reduced study designs and information from other resources such as literature or other studies.

·        We Refine the procedures used in animal research and studies to minimize the discomfort and distress in animals. For each animal study, veterinarians and animal health experts are consulted on the best standard of care and to optimize the veterinary practices used.

GST NV is member of the European Animal Research Association