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Article > Dompe puts type 1 diabetes drug into Phase III

Article > Dompe puts type 1 diabetes drug into Phase III | EPO Patents Science Medicine | Scoop.it

...The compound, a selective chemokine interleukin-8 inhibitor, has shown to improve the efficacy of transplantation of insulin-producing pancreatic islets, which Dompe says is "the new frontier in type 1 diabetes". The Phase III trial will be conducted in 10 centres in Europe and the USA on some 60 patients, which the Milan-headquartered company notes is half the total number of patients undergoing allogeneic pancreatic islet transplantation worldwide....


Via Ellen H Ullman, MSW
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Rescooped by PatentLawEPO from diabetes and more
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Real-time assessment of encapsulated neonatal porcine islets prior to clinical xenotransplantation - Kitzmann - 2012 - Xenotransplantation - Wiley Online Library

Real-time assessment of encapsulated neonatal porcine islets prior to clinical xenotransplantation - Kitzmann - 2012 - Xenotransplantation - Wiley Online Library | EPO Patents Science Medicine | Scoop.it

Abstract: Background: Porcine islet transplantation is emerging as an attractive option for the treatment of patients with type 1 diabetes, with the possibility of providing islets of higher and more consistent quality and in larger volumes than available from human pancreata. The use of encapsulated neonatal porcine islets (ENPI) is appealing because it can address islet supply limitations while reducing the need for anti-rejection therapy. Pre-transplant characterization of ENPI viability and potency is an essential component of the production process. We applied the validated assay for oxygen consumption rate normalized for DNA content (OCR/DNA) to characterize ENPI viability.

Methods: ENPI of low viscosity and high m alginate were prepared according to standard methods and characterized at various culture time points up to 5 weeks.

Results: The OCR/DNA (nmol/min·mgDNA ± SEM) of ENPI (235 ± 10, n = 9) was comparable to that of free NPI (255 ± 14, n = 13). After encapsulation, NPI OCR/DNA was sustained over a culture period of up to 5 weeks. The average OCR/DNA of ENPI cultured longer than 9 days was higher than that of freshly encapsulated NPI.

Conclusion: This is the first characterization of ENPI by a validated and more sensitive method for product viability. The NPI encapsulation process does not compromise viability as measured by OCR/DNA, and ENPI can be cultured for up to 5 weeks with maintenance of viability. ENPI meet or exceed current adult porcine islet product release criteria (established at the University of Minnesota) for preclinical xenotransplantation in terms of OCR/DNA.


Via Ellen H Ullman, MSW
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