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Shortly after the launch of Solving Diabetes we received a number of penetrating questions from “J P Marat”. With his permission the resulting dialogue with Scott King has been edited for inclusion in Straight Talk. “J P Marat” is the pen name of a diabetes researcher in Canada. The dialogue has been formatted to enable further dialogue from readers.
You report that clinical studies in humans are expected to begin for your work in 2013, but you must have noticed that LCT is already claiming that it will be ready to offer its product on a commercial basis in 18 months. Do you believe your product will be so much better than LCT’s that the delay will be worth it?
Since you sent your question, JP, LCT announced the establishment of a Russian subsidiary that expects to make the product available at their new St. Petersburg clinic in October 2010. (It is refreshing to know there is a regulatory regime on this earth that permits you to know more than a year in advance when your product will be available to patients.) Therefore it is very likely that the LCT product (DIABECELL®) will be on the market long before the Islet Sheet.
We consider the Islet Sheet to be the second generation islet encapsulation device. Why is a second generation product needed?
The major advantage of the Islet Sheet compared with microcapsules is that the Islet Sheet can be retrieved and replaced, an additional layer of safety. Islet containing devices are literally alive, and the cells inside are responding to the environment with varying secretion of hormones. (There is no comparable product in routine medical use; this is a fundamentally new medical product category.) As you observe JP, these cells are not getting nutrients through normal vascularization but rather through diffusion. We are uncertain of the long term effects of cells receiving all their nutrients by diffusion rather than vascularization. We do know that they are exempt from normal immune surveillance. (Immune cells travel mostly through the blood stream and therefore would not be able to reach islets in Islet Sheets.) Some risk remains that the encapsulated cells might transform into malignant cells or teratomas. That’s why it is so important that the device can be removed. (This is especially important for stem cell islets, where the risks seem high.) We have already removed Islet Sheets even following an intentionally induced local tissue reaction. That is why I am convinced that the Islet Sheet is the encapsulation device of choice, because the Islet Sheet is demonstrably safer.
Put it this way. If the islets function well in both microcapsules and the Sheet, and only one can be removed, which one would you choose?
If the encapsulated islets undergo a malignant transformation and metastasize before the capsule can be withdrawn — which might well happen, since many cancers are not identified until after metastasis — then this seems to be a risk which would be difficult to eliminate.
We don’t think that is possible. We can make Islet Sheets so strong that dividing cells cannot burst out. And, in addition, the cells would be allo or xeno and so rapidly rejected by the host. (Metastatic cells are autologous.)