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-15 Full Insulin independence after transplantation of 3D bionic pancreatic tissue petals – large animals results

Michal Wszola, Poland

Polbionica Sp. z o.o.
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A transplant surgeon, dedicated physician and visionary scientist, and CEO of Polbionica Inc. Originator of the bionic pancreas – an organ that will restore the body’s ability to regulate blood sugar and revolutionize the treatment of diabetes. He has been running a medical practice for years, leading a team that conducts innovative research - on a global scale – and searches for innovative solutions in medicine. He participated in the first pancreatic islet transplant in Poland (2008), the first pancreas-only transplant (2010) and the first exchange of kidney pairs between family donors (2015). The combination of his passions, transplantology and endoscopy, led to the creation of a new method of treating diabetes – endoscopic transplantation of pancreatic islets under the gastric mucosa. In 2013, he performed first such procedure in the world, which is now tested in several centers in the United States of America. He is currently continuing to work on a 3D printing project of a bionic pancreas with a research team at the Foundation of Research and Science Development. Since 2017, the Foundation, as the leader of the Bionic Consortium, has been working on the implementation of the bionic pancreas project. After only 2 years of preparation and testing, we printed the world’s first vascularized bionic pancreas prototype measuring 3x3x5cm. The 14th of March 2019 is the day when the team proved themselves and the world that the impossible became possible and that tissue and organ bioprinting is the future of modern medicine that will change the lives of many patients. Our mission is to bring 3D printing of the bionic pancreas into clinical practice worldwide. Nowadays a broad spectrum of scientific data showing results of transplantation into large animals of 3D bioprinted bionic pancreas are being presented.


Full Insulin independence after transplantation of 3D bionic pancreatic tissue petals – large animals results

Michal Wszola1,2,3, Marta Klak1,2, Andrzej Berman1,2,3, Oliwia Janowska1, Dominika Ujazdowska2, Sylwester Domański1, Tomasz Dobrzanski1, Dominika Szkopek4, Anna Filip2, Katarzyna Roszkowicz-Ostrowska4, Agata Kondej4, Jaroslaw Wolinski4, Artur Kaminski5, Agnieszka Dobrzyn6.

1Polbionica Sp. z o.o., Warsaw, Poland; 2Foundation of Research and Science Development, Warsaw, Poland; 3Medispace Sp. z o.o., Warsaw, Poland; 4Institute of Animal Physiology and Nutrition Jan Kielanowski of the Polish Academy of Sciences, Jablonna, Poland; 5Medical University of Warsaw, Warsaw, Poland; 6Institute of Experimental Biology M. Nencki PAN, Warsaw, Poland

Islets transplantation (ITx) is on the crossroad - in the US is treated as a drug, not a tissue transplantation, in Europe a few countries have a reimbursement for it. Moreover, the ITx results are inferior then it was expected. Search for a new implantation site didn’t bring a breakthrough and still intra-portal ITx with its problems like instant blood-mediated inflammatory reaction(IBMIR) or stripping-off islets from extracellular matrix(ECM) after isolation is a gold standard. Nowadays a few attempts of stem-cell derived beta cells clusters (SCD-Beta) ITx has been shown with inconsistent results. Xeno-derived ITx are also ahead. It seems that ITx into portal vein SCD-Beta or Xeno-derived islets can face an exactly the same problems like standard donor derived ITx-IBMIR, lack of ECM and lack of insulin-independence. Additional safety reasons as such clusters in some extend will not be left in the liver make it difficult to monitor.

The aim of this study was to show results of ITx in large animals of 3Dbioprinted bionic pancreatic tissue models with pancreatic islets as a further model to be used with SCD-Beta clusters or Xeno-derived islets.

MATERIALS & METHODS: 12 domestic pigs (weighing~30 kg) were divided into 4 groups: healthy pigs (n=3); animals after total pancreatectomy, treated with insulin(T1D;n=3); animals after total pancreatectomy and autotransplantation of pancreatic islets into the liver(Liver; n=3); animals after total pancreatectomy, and autotransplantation of 3Dbioprinted bionic pancreatic tissue petals with islets (3D-Petals; n=3). The effectiveness of the ITx was assessed by the daily insulin intake, C-peptide and glucose concentration up to 2 months post-ITx. 3Dbioprinted bionic pancreatic tissue models had 3x3x0.3cm in diameters and were transplanted between rectal muscle and peritoneum.

RESULTS: 3D-Petals group reached full insulin-independence within 4 to 6 weeks post-ITx. Insulin intake in 2,4,6 weeks after ITx was 42;16;0% of T1D group requirement respectively(P<0.01). Insulin intake in the Liver group in 2,4,6 weeks after ITx was 24;76;69% of T1D requirement respectively(P<0.01). Non of liver group achieved insulin-independence. Mean fasting C-peptide  at 0,2,4,6, weeks in healthy group was :1.7,1.51,1.52,1.21 ng/mg vs. 1.5,0,0,0 ng/ml in T1D group. C-peptide levels  before  and post-pancreatectomy and 2,4,6,8 weeks post-ITx in 3D-Petals was 1.9;0.0;0.3;0.16;0.3;0.32 ng/ml vs.  2.2;0.0;0.25;0.1;0.1;0.1 ng/ml in the Liver respectively (p<0.05). The mean insulin intake in the T1D group was 5;5.2;6.4;6.8IU in 2,4,6,8 weeks after pancreatectomy. In the LIVER group was 1.2;3.95;4.4;5IU vs. 2.1;0.85;0.0;0.2IU in the 3D-Petals in 2,4,6,8 weeks after pancreatectomy and ITx.

CONCLUSION: 3DBioprinted bionic pancreatic tissue petals transplantation achieved FULL insulin-independence in all animals which could be good prognostic before ITx of 3Dbioprinted pancreatic tissue with stem-cell derived islets. 


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