What is clear is that the current SOC, islet cell transplantation via portal vein infusion, leaves lots of room for improvement.
Firstly, there is the limited supply of islet cells. There is a global shortage of donor organs and less than a third of the pancreatic organs donated are usable for this procedure. Add to this the fact that the islet cells are very difficult to retrieve, difficult to transport and can’t be frozen and thawed like other organs.
Seventy-five percent of what is transplanted is then lost within the first 48 hours post-transplant, due to post-transplantation inflammatory reaction.
Potential adverse events from the portal vein transplantation procedure are significant and include liver laceration/haematoma, haemorrhage, intra-abdominal bleeding and elevation of portal pressure, as seen during the Lantrida clinical trials.
Then there’s the immune reaction - immunosuppressant drugs are required and these also come with their own side effects.
Ultimately, the long-term clinical prognosis of patients undergoing traditional portal vein transplantation is poor.
You ask whether the Novosorb neodermis cell delivery system is the best solution out there.
I don’t think we know enough yet to make a judgement on that.
The Novosorb neodermis cell delivery system certainly answers many of the problems of the current SOC – it’s a less invasive, outpatient/physician room procedure and hence would be much cheaper. Far less cell death, therefore more transplants possible. Portal vein procedure side effects avoided. Easy to monitor and remove if there’s a problem. Local immunosuppression is said to be a possibility and would be an improvement on systemic immunosuppression, but that is yet to be demonstrated.
However, if the Novosorb system is going to be used more widely, it will need to be combined with a more sustainable source of cells, such as stem cells. Ideally, those cells would be engineered to avoid the immune response.
I also hold the view that, as things stand, there is no quick path to approval in the United States, where the FDA regulates islet cells as a drug rather than a tissue or organ.
But that’s ok if there’s a swift path to market elsewhere.
With its multiple potential advantages compared with SOC, existing C E Mark approval for Novosorb BTM, successful proof of concept study and patented protection, my view is that the Novosorb neodermis cell delivery system has what is needed to generate keen interest from other companies.
Major players in this space are Novo Nordisk, Eli Lilly and Vertex.
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