RE:RE:BioHubYeah, I've seen that. Weird part is that Camillo Ricordi and Tomei were the ones who came up with the Conformal Coating. If they are working on something similar on their own, why would they license it out to Sernova?
Only thing I can think of is that they don't have cells but this is from 2014 so I'm sure they could have teamed up with Semma, Evotec, etc. etc. The other potential issue is their device but it seems it had cured diabetes in 2015 so not exactly sure whats missing.
Interview with Ricordi makes mention of Conformal Coating:
When will the BioHub be available to patients?
We are aggressively moving the BioHub toward clinical trials. We anticipate that the first clinical trials to test components of the BioHub will take place in 2014, and we’ve already started down the regulatory path with the FDA. We will test transplanting islets alone within scaffolds made of clinical grade silicone. This material has been used clinically in many applications and therefore should more easily receive FDA approval. The study will also evaluate the placement of this BioHub platform within the omentum (abdominal lining) and its ability to regulate blood sugar levels.
We also are submitting protocols to the FDA in collaboration with Dr. Suzanne Ildstad at the University of Louisville, and with Northwestern University, to perform the first trials that will specifically target islet transplantation that completely remove anti-rejection drugs.
So it’s very exciting.
How can people enroll in the clinical trials?
The best way to remain informed as to when clinical trials will begin is by becoming a DRInsider. For sure, we will announce it and it will be known when enrollment will begin. We expect to be enrolling patients possibly before the end of this year and for sure next year.
What progress have we seen leading up to these clinical trials?
We have tested several components of the BioHub in sub-human primates, including co-transplanting islets with “helper” cells (mesenchymal stem cells) within the scaffold platform, and testing this within an omental pouch (an abdominal lining).
We have also tested our conformal coating cell encapsulation strategy in which we “shrink wrap” the islet cells with a protective barrier. After several modifications, the coatings were able to protect transplanted islets from rejection while maintaining normal blood sugar levels in the experimental models. In these studies, diabetes was reversed in less than one week and the islets continued to function long term without the use of any anti-rejection drugs.
We also are conducting clinical trials at collaborating DRI Federation centers, showing that it is possible to substantially decrease immunosuppression after infusion of mesenchymal stem cells.
Clinical trials at collaborating Cure Alliance centers are indicating that it is possible to discontinue anti-rejection drugs after tolerance-inducing protocols.
We now have new immunomodulatory molecules that were not available a few years ago. These already have been shown to be effective in reversing type 1 diabetes in experimental model systems.
We now have oxygen-generating technology and drug delivery systems to optimize the local micro-environment of the BioHub, which were not available a few years ago.
All of these advances make us increasingly optimistic about our ability to successfully transfer these components to the BioHub platform -- and that biologic replacement of insulin producing cells without systemic immunosuppression is within our reach.
The BioHub is a combination of several interrelated strategies. How do you envision these emerging?
I see us restoring self-tolerance and eliminating autoimmunity by inducing chimerism (ongoing collaboration with Cure Alliance's Dr. Suzanne Ildstad from University of Louisville and collaborators).
The same technology already has been successful in eliminating immunosuppression -- anti-rejection drugs -- in organ transplantation. That’s been working for more than three years and counting. We believe we can use this when transplanting insulin-producing cells within the BioHub
The additional technologies incorporated in the BioHub could represent alternative or complementary ways to avoid treating the recipients with anti-rejection drugs. That remains the central objective of the entire project.
The BioHub will eventually be applicable to any source of insulin-producing cells. Using islets is just the first, not the final, step.