Aug 1 2007
Living Cell Technologies Limited today announced the publication of a scientific paper endorsing the micro-encapsulation technology used in the cell-based therapeutic product, DiabeCell®.
Micro-encapsulation technology is used extensively as a technique for introducing cell-based therapeutics into the body. Living Cell has developed a unique biocapsule that is used in the DiabeCell® product, to coat pancreatic islet cells and to prevent immune rejection when transplanted into the abdomen of type I diabetes patients.
The study, published in the peer-reviewed scientific Journal of Biomedical Materials Research Part A compared the stability and longevity of Living Cell’s micro-encapsulation technology to other baseline technologies. The study revealed that Living Cell’s biocapsules, when implanted in rats, were able to survive for a longer period in the abdomen than other technologies.
“As we enter into clinical trials of DiabeCell®, it is important that our biomaterials team has come up with a novel alginate that will make our cell-based therapeutic products more durable and functional long-term when implanted in the patient’s body,” said LCT CEO, Dr Paul Tan.
Living Cell has produced a stable biocapsule made of ultra-pure alginate that is capable of surviving in diverse transplant sites, including the harsh environment inside the abdomen for at least 215 days, the study endpoint. This is in contrast to the baseline (commercially available alginate) formulated capsules that remained stable for less than 60 days in the same anatomical location. Both the LCT and baseline biocapsules were tested without live cells inside.
According to an alginate pioneer, and LCT's collaborator, Professor Riccardo Calafiore at the University of Perugia in Italy: "We have found a way to purify alginate for making smooth, long surviving capsules without surface pitting, so that inner layers and cells inside are not exposed. This purified alginate can now be made consistently from a natural seaweed-derived material." LCT holds an exclusive license and rights to the Perugia alginate.
Alginate, in its purest form can be an extremely biocompatible barrier – being resistant to attack to the host immune system, while simultaneously enabling diffusion of cell secreted proteins across the microcapsule membrane wall into the body. It has been widely used to introduce cell-based therapeutics into the body but success has varied greatly due to methods of manufacture and formulation.
Living Cell has filed patents on its purified alginate. The Company’s alginate selection criteria are critical to its intellectual property position. Previously, Living Cell reported survival of biocapsules 10 years after implant in a prototype product, indicating that the new biocapsules used in the DiabeCell® product may enable significant longevity beyond the scope of this study, which may eventually reduce the frequency of implantations required by the patient.
“We look forward to the results of our DiabeCell® clinical trial in 2008, and believe that it will provide further validation of our unique alginate biocapsule,” said Dr Tan.