New Generation Cell Therapy: Bioartificial Pancreas to Cure Type 1 Diabetes

Deliverables

ACCEL will create a communication portfolio of updated VANGUARD print visual and media information and documentation including factsheets brochures and posters and visual content will be developed to offer information about the project in a condensed form that can be handed out during various events and downloaded from the project website

VANGUARD Stakeholder Engagement and Dissemination Assessment Reports

To asses the implementation and impact of the stakeholder engagement and dissemination activities, ACCEL will monitor and document (D9.4, M48) the implemented measures to assess the individual activities and adapt any activities where required to facilitate outreach and impact M24 and 48)

ELSA Training Manual

Training of VANGUARD researchers in M6, in particular newly recruited staff, on the ethical implications and safety requirements involved in regenerative medicine in general and the therapy developed during the VANGUARD project. The existing literature will be reviewed, experts in bioethics consulted, and together with partners we will develop a training manual.

Project website

To support aforementioned dissemination and communication activities throughout the duration of the project, ACCEL will set up and maintain the project website, which will notably function as the main source of information and resources related to the project, partners, latest developments, publications and public deliverables for all stakeholders.

Publications

Vascularized endocrine pancreas for type 1 diabetes

Author(s): Bellofatto, Kevin; Lebreton, Fanny; Fonseca, Laura Mar; Hanna, Reine; Bignard, Juliette; Galvan, Victor; Peloso, Andrea; Berney, Thierry; Compagnon, Philippe; VANGUARD Consortium; Berishvili, Ekaterine
Published in: Transplantation, Issue 107, 2023, Page(s) 58
Publisher: Lippincott Williams & Wilkins Ltd.
DOI: 10.1097/01.tp.0000994052.77218.10

Ethics of Early Clinical Trials of Bio-Artificial Organs

Author(s): Bunnik, E.M., de Jongh, D. and Massey, E.
Published in: Transplant International, Issue 35, 2022, Page(s) 10621, ISSN 0934-0874
Publisher: Frontiers Publishing Partnerships
DOI: 10.3389/ti.2022.10621

Generation of Prevascularized Endocrine Constructs to Treat Type 1 Diabetes

Author(s): Bellofatto K, Lebreton F, Wassmer CH Fonseca L, Hanna R, Berishvili E.
Published in: Transplantation, Issue 9, 2022
Publisher: Lippincott Williams & Wilkins
DOI: 10.1097/01.tp.0000885936.38573.32

Hydrogel-based, prevascularized, retrievable endocrine construct to treat Type 1 Diabetes

Author(s): Bellofatto K, Lebreton F, Hanna R, Fonseca L M, Bignard J, Galvan V, Peloso A, Berney TH, Compagnon PH, VANGUARD Consortium, Berishvili E.
Published in: Transplantation, Issue 107, 2023, Page(s) 57
Publisher: Lippincott Williams & Wilkins Ltd.
DOI: 10.1097/01.tp.0000994048.59940.dd

Mechanisms of Immunomodulation and Cytoprotection Conferred to Pancreatic Islet by Human Amniotic Epithelial Cells

Author(s): Lebreton F, Hanna R, Wassmer CH, Bellofatto K, Perez L, Othenin-Girard V, de Tejada BM, Cohen M, Berishvili E.
Published in: Stem Cell Reviews and Reports, Issue 18, 2021, Page(s) 346-359, ISSN 1550-8943
Publisher: Springer Verlag
DOI: 10.1007/s12015-021-10269-w

Formation of Re-Aggregated Neonatal Porcine Islet Clusters Improves In Vitro Function and Transplantation Outcome

Author(s): Honarpisheh M, Lei Y, Zhang Y, Pehl M, Kemter E, Lange A, Wolf E, Wolf-van Buerck L, VANGUARD consortium, Seissler S.
Published in: Transplant International, Issue 35, 2022, ISSN 1432-2277
Publisher: Frontiers
DOI: 10.3389/ti.2022.10697

Targeting Toll-Like Receptor 4: a promising strategy to prevent type 1 diabetes occurrence or recurrence

Author(s): Alibashe-Ahmed M., Berney T., Giovannoni L., Berishvili E.
Published in: CellR4, Issue 8, 2020, ISSN 2329-7042
Publisher: Verduci International
DOI: 10.32113/cellr4_20205_2850

Regulatory Challenges at the Intersection of Cellular and Medical Device Therapies in Europe: The Case of the Bioartificial Pancreas

Author(s): Cronin AJ, Thom RL.
Published in: Law, Technology and Human, Issue 5(2), 2023, ISSN 2652-4074
Publisher: QUT
DOI: 10.5204/lthj.3118

Immunomodulatory Properties of Amniotic Membrane Derivatives and Their Potential in Regenerative Medicine

Author(s): Charles-Henri Wassmer, Ekaterine Berishvili
Published in: Current Diabetes Reports, Issue 20/8, 2020, Page(s) 31, ISSN 1534-4827
Publisher: Current Science Inc.
DOI: 10.1007/s11892-020-01316-w

Generation of insulin‐secreting organoids: a step toward engineering and transplanting the bioartificial pancreas

Author(s): Charles‐Henri Wassmer, Fanny Lebreton, Kevin Bellofatto, Domenico Bosco, Thierry Berney, Ekaterine Berishvili
Published in: Transplant International, Issue 33/12, 2020, Page(s) 1577-1588, ISSN 0934-0874
Publisher: Blackwell Publishing Inc.
DOI: 10.1111/tri.13721

Factor VIII, a coagulation cofactor, is a relevant survival factor in bladder cancer cell lines

Author(s): Gillian E. Walker, Ester Borroni, Rida Haider, Cristina Olgasi, Chiara Borsotti, Antonia Follenzi
Published in: Journal of Thrombosis and Haemostasis, 2025, ISSN 1538-7836
Publisher: Elsevier BV
DOI: 10.1016/j.jtha.2025.03.002

Organoids: a systematic review of ethical issues

Author(s): Dide de Jongh, Emma K. Massey , the VANGUARD consortium*, Eline M. Bunnik
Published in: Stem Cell Research & Therapy, Issue 13, 2022, Page(s) 337, ISSN 1757-6512
Publisher: BioMed Central
DOI: 10.1186/s13287-022-02950-9

Treatment of COVID-19 Pneumonia: the Case for Placenta-derived Cell Therapy

Author(s): Ekaterine Berishvili, Laurent Kaiser, Marie Cohen, Thierry Berney, Hanne Scholz, Yngvar Floisand, Jonas Mattsson
Published in: Stem Cell Reviews and Reports, Issue 17/1, 2021, Page(s) 63-70, ISSN 2629-3277
Publisher: Springer
DOI: 10.1007/s12015-020-10004-x

Spheroids Composed of Reaggregated Neonatal Porcine Islets and Human Endothelial Cells Accelerate Development of Normoglycemia in Diabetic Mice

Author(s): Mohsen Honarpisheh, Yutian Lei, Antonia Follenzi, Alessia Cucci, Cristina Olgasi, Ekaterine Berishvili, Fanny Lebreton, Kevin Bellofatto, Lorenzo Piemonti, Antonio Citro, Francesco Campo, Cataldo Pignatelli, Olivier Thaunat, Elisabeth Kemter, Martin Kraetzl, Eckhard Wolf, Jochen Seissler, Lelia Wolf-van Buerck, null null
Published in: Cells, Issue 14, 2025, Page(s) 366, ISSN 2073-4409
Publisher: MDPI AG
DOI: 10.3390/cells14050366

Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues

Author(s): de Jongh, D., Massey, E. K., Cronin, A. J., Schermer, M. H. N., Bunnik, E. M. and the VANGUARD Consortium
Published in: Transplant International, Issue 14322277, 2022, ISSN 1432-2277
Publisher: Frontiers Publishing Partnership
DOI: 10.3389/ti.2022.10751

Engineering of Primary Pancreatic Islet Cell Spheroids for Three-dimensional Culture or Transplantation: A Methodological Comparative Study

Author(s): Charles-Henri Wassmer, Kevin Bellofatto, Lisa Perez, Vanessa Lavallard, David Cottet-Dumoulin, Sanda Ljubicic, Géraldine Parnaud, Domenico Bosco, Ekaterine Berishvili, Fanny Lebreton
Published in: Cell Transplantation, Issue 29, 2020, Page(s) 096368972093729, ISSN 0963-6897
Publisher: Cognizant Communication Corp.
DOI: 10.1177/0963689720937292

Efficient and safe correction of hemophilia A by lentiviral vector-transduced BOECs in an implantable device

Author(s): Olgasi, C., Borsotti, C., Merlin, S., Bergmann, T., Bittorf, P., Adewoye, A. B., Wragg, N., Patterson, K., Calabria, A., Benedicenti, F., Cucci, A., Borchiellini, A., Pollio, B., Montini, E., Mazzuca, D. M., Zierau, M., Stolzing, A., Toleikis, P., Braspenning, J., & Follenzi, A.
Published in: Molecular Therapy - Methods & Clinical Development, Issue 23, 2021, Page(s) 551-566, ISSN 2329-0501
Publisher: Cell Press
DOI: 10.1016/j.omtm.2021.10.015

Immunoprotection Strategies in β‐Cell Replacement Therapy: A Closer Look at Porcine Islet Xenotransplantation

Author(s): Sarah Grimus, Victoria Sarangova, Petra B. Welzel, Barbara Ludwig, Jochen Seissler, Elisabeth Kemter, Eckhard Wolf, Asghar Ali
Published in: Advanced Science, Issue 11, 2024, ISSN 2198-3844
Publisher: Wiley
DOI: 10.1002/advs.202401385

Factor VIII promotes angiogenesis and vessel stability regulating extracellular matrix proteins

Author(s): Cristina Olgasi, Alessia Cucci, Ivan Molineris, Simone Assanelli, Francesca Anselmi, Chiara Borsotti, Chiara Sgromo, Andrea Lauria, Simone Merlin, Gillian E. Walker, Salvatore Oliviero, Antonia Follenzi
Published in: Haematologica, Issue 109, 2024, Page(s) 3391-3397, ISSN 0390-6078
Publisher: Ferrata Storti Foundation
DOI: 10.3324/haematol.2024.285089

The bio-artificial pancreas to treat type 1 diabetes: Perspectives from healthcare professionals in the Netherlands

Author(s): Dide de Jongh, Eline Bunnik, Behiye Ozcan, Robert Zietse, Emma Massey
Published in: Journal of Clinical & Translational Endocrinology, Issue 38, 2024, Page(s) 100372, ISSN 2214-6237
Publisher: Elsevier BV
DOI: 10.1016/j.jcte.2024.100372

Legal and Regulatory Challenges for Emerging Regenerative Medicine Solutions for Diabetes

Author(s): Thom RL, Cronin AJ; VANGUARD Consortium.
Published in: Transplantation, Issue 9, 2023, ISSN 0041-1337
Publisher: Lippincott Williams & Wilkins Ltd.
DOI: 10.1097/tp.0000000000004797

Clinical Translation of Bio-Artificial Pancreas Therapies: Ethical, Legal and Psychosocial Interdisciplinary Considerations and Key Recommendations

Author(s): de Jongh D, Thom RL, Cronin AJ, Bunnik EM, Massey EK.
Published in: Transplant international, 2023, ISSN 1432-2277
Publisher: Frontiers
DOI: 10.3389/ti.2023.11705

From islet of Langerhans transplantation to the bioartificial pancreas

Author(s): Thierry Berney; Charles H. Wassmer; Fanny Lebreton; Kevin Bellofatto; Laura Mar Fonseca; Juliette Bignard; Reine Hanna; Andrea Peloso; Ekaterine Berishvili
Published in: La Presse Médicale, Issue 9, 2022, ISSN 0755-4982
Publisher: Elsevier Masson
DOI: 10.1016/j.lpm.2022.104139

Therapeutic potential of fetal liver cell transplantation in hemophilia A mice

Author(s): Simone, Merlin; Saicharan, Akula; Alessia, Cottonaro; Tamara, Garcia-Leal; Luis Javier, Serrano; Ester, Borroni; Vakhtang, Kalandadze; Rocio, Galiano; Chiara, Borsotti; Antonio, Liras; María José, Sanchez; Antonia, Follenzi
Published in: Haematologica, Issue 6, 2023, Page(s) 1544-1554, ISSN 1592-8721
Publisher: Ferrata Storti Foundation
DOI: 10.3324/haematol.2022.282001

What Genetic Modifications of Source Pigs Are Essential and Sufficient for Cell, Tissue, and Organ Xenotransplantation?

Author(s): Asghar Ali, Mayuko Kurome, Barbara Kessler, Elisabeth Kemter, Eckhard Wolf
Published in: Transplant International, Issue 37, 2024, ISSN 1432-2277
Publisher: Frontiers Media SA
DOI: 10.3389/ti.2024.13681

Guidelines to Analyze Preclinical Studies Using Perinatal Derivatives

Author(s): Pires, Salomé; Bollini, Sveva; Botelho, Maria Filomena; Lang-Olip, Ingrid; Ponsaerts, Peter; Balbi, Carolina; Lange-Consiglio, Anna; Fénelon, Mathilde; Mojsilović, Slavko; Cremonesi, Fausto; Bugarski, Diana; Berishvili, Ekaterine; Gazouli, Maria; Gellhaus, Alexandra; Kerdjoudj, Halima; Schoeberlein, Andreina
Published in: Methods and Protocols, 2023, ISSN 2409-9279
Publisher: MDPI
DOI: 10.3390/mps6030045

Bioengineering the Vascularized Endocrine Pancreas: A Fine-Tuned Interplay Between Vascularization, Extracellular-Matrix-Based Scaffold Architecture, and Insulin-Producing Cells

Author(s): Pignatelli C, Campo F, Neroni A, Piemonti L and Citro A
Published in: Transplant International, Issue 14322277, 2022, ISSN 1432-2277
Publisher: Frontiers
DOI: 10.3389/ti.2022.10555

Advances and challenges of endocrine pancreas bioengineering

Author(s): Hanna, R., & Berishvili, E.
Published in: Current Opinion in Endocrine and Metabolic Research, Issue 23, 100320, 2022, ISSN 2451-9650
Publisher: Elsevier Ltd.
DOI: 10.1016/j.coemr.2022.100320

Allogeneic Islet Transplantation: Chronicle of a Death Foretold?

Author(s): Thierry Berney, Olivier Thaunat, Ekaterine Berishvili
Published in: Transplant International, Issue 38, 2025, ISSN 1432-2277
Publisher: Frontiers Media SA
DOI: 10.3389/ti.2025.14598

I’ve got you under my skin

Author(s): Thierry Berney, Ekaterine Berishvili
Published in: Nature Metabolism, Issue 2/10, 2020, Page(s) 993-994, ISSN 2522-5812
Publisher: Nature Research
DOI: 10.1038/s42255-020-0268-8

Bio-Engineering of Pre-Vascularized Islet Organoids for the Treatment of Type 1 Diabetes

Author(s): Wassmer, C.H., Lebreton, F., Bellofatto, K., Perez, L., Cottet-Dumoulin, D., Andres, A., Bosco, D., Berney, T., Othenin-Girard, V., Martinez De Tejada, B., Cohen, M., Follenzi, A., Berishvili, E., and the VANGUARD Consortium
Published in: Transplant International, Issue 35, 2022, ISSN 1432-2277
Publisher: Frontiers
DOI: 10.3389/ti.2021.10214

Clinical Translation and Implementation of a Bioartificial Pancreas Therapy: A Qualitative Study Exploring the Perspectives of People With Type 1 Diabetes

Author(s): Dide de Jongh, Silke Lapré, Behiye Özcan, Robert Zietse, Eline M. Bunnik, Emma K. Massey, null null
Published in: Transplantation Direct, Issue 10, 2025, Page(s) e1711, ISSN 2373-8731
Publisher: Ovid Technologies (Wolters Kluwer Health)
DOI: 10.1097/txd.0000000000001711

Organoïdes sécréteurs d’insuline

Author(s): Fanny Lebreton, Charles-Henri Wassmer, Kevin Belofatto, Thierry Berney, Ekaterine Berishvili
Published in: médecine/sciences, Issue 36/10, 2020, Page(s) 879-885, ISSN 0767-0974
Publisher: Editions E D K
DOI: 10.1051/medsci/2020129

Deliverables

Publications

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