The treatment, known as DiabeCell, has been approved for Phase I/IIa trials in New Zealand after the trial in Russia reported no adverse effects since it began in June 2007.
DiabeCell consists of porcine cells that are encapsulated in alginate capsules, which provides a barrier to stop the immune system from attacking. This negates the need for use of immunosuppressants after the cells have been transplanted into the abdomen.
Although the pores are small enough to prevent elements of immune system from reaching the cell they are large enough to allow nutrients through.
This enables the porcine cells to continue to produce insulin over a prolonged period of time, with Dr Robert Caspari, CEO of LCT, saying in an interview that a patient from the Russia trial had lived with the porcine cells for over one year. He added that LCT planned to follow patients for their whole lives.
A primary goal of LCT’s clinical trialsis to discover how long the cells will continue to produce insulin, as well as monitoring the patients’ response to the treatment.
The porcine cells are taken from LCT’s biocertified herd, which is made up of pigs taken from a very small island on which they were abandoned 200 years ago by a sealing ship.
LCT’s herd is kept in a very sterile environment and monitored to ensure the transplanted pig cells do not transmit disease to their host.
This caution is designed to ensure patient safety and ease the fears of regulators who may have concerns over transplantation and Caspari hopes that the New Zealand approval will ease the process in other countries.
Caspari said that the construction of further pig houses around the world will be necessary if the product is to be commercialised, which will potentially be cash intensive.
However, the product will not require a huge budget for sales and marketing and consequently Caspari believes that LCT could bring the product to market without the need for a partner.
If commercialised Caspari believes the treatment will predominately be used in clinics and diabetes centres, which could significantly reduce the healthcare costs associated with type 1 diabetes.
As well as the financial benefits the treatment has the potential to greatly benefit the lives of those living with type 1 diabetes. Around 3m in the world, many of whom are children, live with type 1 diabetes and suffer from fluctuating glucose levels, which need to be monitored and controlled.
This can cause long tem health complications and also has a detrimental affect upon the quality of life of the individual suffering from type 1 diabetes and their family.
Data released from the trials so far have shown that the treatment can significantly reduce daily insulin requirements and minimise fluctuations in glucose levels.