A remarkable new device for the treatment of liver disease is now one step nearer to being available in the UK and Europe, thanks to a unique collaboration between Wellspring Clinical Services and San Diego-based company Vital Therapies, the developers of a human liver cell-based device.
Known as an extracorporeal liver assist device (ELAD), the machine acts as an artificial liver, taking over a person’s liver function for a few days or weeks to keep them alive until either a transplant becomes available, or the liver regenerates on its own.
Currently liver transplantation is the only therapy proven to extend survival but the waiting list for liver transplants is extensive and many on the list will not receive an organ due to a shortage of donors. Many more patients do not qualify for transplantation.
ELAD has the potential to improve survival and quality of life for patients who experience liver failure. The treatment is already undergoing investigational clinical trials in the US and China and early results suggest that there is significant improvement in transplant-free survival for acute and chronic liver failure patients treated with ELAD.
The first patient in the UK received the treatment thanks to Vital Therapies and specialists in unlicensed medicines and clinical trials from Wellspring, who became involved after they were contacted by University College London Hospital. The hospital was treating a young patient with acute liver failure and needed access to ELAD. A team of specialists from Wellspring with expertise in the use of biologicals promptly flew out to San Diego to audit the production facilities.
As a result of Wellsprings’ involvement, Vital Therapies was able to navigate the regulations concerning named-patient basis and import the advanced therapy product into the UK at the request of a doctor. The ELAD equipment and cartridges containing the human liver cells were delivered to the UCLH within just 48hr of leaving the production facility in the US; the time in which live cells have to reach the patient. Wellspring now acts as a holding hub for ELAD, which is available to specialist liver centres in the UK and across Europe on a named-patient basis.
Dr Catherine Harper, Wellspring’s clinical trials business manager, says: “Vital Therapies had already approached a number of QPs but none felt they had the expertise needed to release a biological. My knowledge as a biologist with a cell culture and transplant background, combined with that of our QP Steve Garner, meant we were confident that we could successfully help Vital Therapies release their product.”
As a direct result of Wellsprings’ biological audit, an application to commence the first clinical trial across three UK centres involving patients suffering from acute liver failure has been approved by the MHRA. Wellspring is currently co-ordinating the importation, shipping and logistics for the trial, which will subsequently be rolled out to Denmark, Germany, Spain and France and involve over 80 patients.
Catherine continues: “We are hugely excited to be working with a company who are at the cutting edge of live cell culture technology. It also opens up many more potential opportunities to us and we are now able to offer our services and expertise to other pharmaceutical companies wanting to bring new cell therapies into Europe.”