Novo Nordisk believes that stem cell research is essential to understand how cells grow and develop, and how they are affected in different diseases. This knowledge allows us to use human pluripotent stem cells to develop cell therapies for the treatment of people suffering from serious chronic diseases in areas of significant unmet medical need.

We recognise and respect that stem cell research may give rise to ethical questions that need to be thoroughly discussed in society. We are committed to being part of an open discussion about these matters, particularly in relation to the use of human pluripotent stem cells for development of new medicines. This concerns both the use of cells that are derived from a fertilised human ovum, known as human embryonic stem cells, and those derived from adult cells that are reprogrammed back to stem cells, known as induced pluripotent stem cells.

We urge all countries to establish regulation and legislation that will ensure that stem cell research and cell therapy development is appropriately controlled to ensure patient safety and protection of donor rights.

1. Vision to defeat diabetes and other serious chronic diseases
Novo Nordisk is driving change to defeat serious chronic diseases. Cell therapies derived from human pluripotent stem cells have the potential to realise this vision, and we see a particular opportunity to develop curative treatments that could alleviate the burden of disease and the associated chronic treatment

2. Use of human pluripotent stem cells
We are exploring the use of different types of human pluripotent stem cells as a starting material for the development of cell therapies: embryonic stem cells and induced pluripotent stem cells. The stem cells are derived from donors and expanded into cell banks, providing an unlimited source of cells from just one donor or one donor couple. The stem cells are then differentiated into specific cell types, such as insulin producing beta cells, which could be used to help treat people with diabetes or dopamine producing neurons, for people living with Parkinson’s Disease.

We also apply stem cell research to increase disease understanding and improve the drug discovery process. 

3. Human embryonic stem cells
We work with human embryonic stem cells derived from embryos generated for in vitro fertilisation (IVF). During this procedure more embryos may be generated than are needed for the IVF treatment. The surplus embryos are freely donated under informed consent by the couples undergoing the fertilisation procedure. These embryos are not used for implantation and would by regulations otherwise be destroyed at the IVF clinic. The stem cells to be used for development of new cell therapies are extracted from the embryo at the blastocyst stage. A blastocyst is a cluster of less than 200 cells representing a state of early embryonic development in which the stem cells have not yet matured into any specific cell types. 

4. Induced pluripotent stem cells
We derive induced pluripotent stem cells from human cells, such as skin or blood cells. These are adult cells that are subsequently reprogrammed back to stem cells. The cells are freely donated under informed consent, for development of cell therapies, and the donation is regulated according to applicable laws and regulations.

5. Patenting of stem cells and cells derived from stem cells
We support the position that human embryonic stem cells and the original human cells derived from them cannot be patented. However, we agree that the research-based protocols used to develop stem cells into therapeutic cells could be patentable.

6. Legal framework
We encourage a clear international legislative framework and regulations around the use of human pluripotent stem cells that also ensures that the knowledge obtained can be used for development of cell therapies to help people suffering from serious chronic diseases.

7. Efficacy and safety standards for cell therapies
We believe that cell therapies made from human pluripotent stem cells should only be made available for the treatment of patients once they have been proven to be safe and efficacious in adequately controlled clinical trials and approved by appropriate regulatory bodies.