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Outcomes

VANGUARD WORKSHOPS

Ethics of early clinical trials in regenerative medicine in transplantation | Online, Thursday 3 February 2022

Bio-artificial organs and bio-engineered or bio-printed tissues for transplantation in humans are rapidly being developed. It is anticipated that some applications will be ready for clinical testing in the near future. How can first-in-human clinical trials be conducted in a safe and responsible manner? What are ethical points to consider for early clinical trials of regenerative medicine in transplantation? This workshop brings together experts in the fields of regenerative medicine and ethics to discuss these ethical challenges.

This video shows the full recording of the VANGUARD Ethics workshop held online, Thursday 3 February 2022 from 16:0018:00.

SCIENTIFIC PUBLICATIONS

Below is a list of all accepted VANGUARD scientific publications available to date. Further publications as well as conference posters, proceedings and presentations will be added when available.

      1. STEM CELL RESEARCH & THERAPY, 2022
        Organoids: a systematic review of ethical issues
        de Jongh D, Massey E, and Bunnik E M.
      2. TRANSPLANT INTERNATIONAL, 2022
        Ethics of Early Clinical Trials of Bio-Artificial Organs
        Bunnik E M, de Jongh D, and Massey E.
      3. CURRENT OPINION IN ENDOCRINE AND METABOLIC RESEARCH, 2022
        Advances and challenges of endocrine pancreas bioengineering
        Hanna R and Berishvili E.
      4. TRANSPLANT INTERNATIONAL, 2022
        Bio-Engineering of Pre-Vascularized Islet Organoids for the Treatment of Type 1 Diabetes
        Wassmer CH, Lebreton F, Bellofatto K, Perez Lisa, Cottet-Dumoulin D, Andres A, Bosco D, Berney T, Othenin-Girard V, Martinez de Tejada B, Cohen M, Olgasi C, Follenzi A, and Berishvili E.
      5. STEM CELL REVIEW AND REPORTS, 2021
        Mechanisms of Immunomodulation and Cytoprotection Conferred to Pancreatic Islet by Human Amniotic Epithelial Cells
        Lebreton F, Hanna R, Wassmer CH, Bellofatto K, Perez L, Othenin-Girard V, Martinez de Tejada B, Cohen M, and Berishvili E.
      6. MOLECULAR THERAPY – METHODS & CLINICAL DEVELOPMENT, 2021
        Efficient and safe correction of hemophilia A by lentiviral vector-transduced BOECs in an implantable device
        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, and Follenzi A.
      7. NATURE METABOLISM, 2020
        I’ve got you under my skin
        Berney T, Berishvili E.
      8. TRANSPLANT INTERNATIONAL, 2020
        Generation of insulin-secreting organoids: a step toward engineering and transplanting the bioartificial pancreas
        Wassmer CH, Lebreton F, Bellofatto K, Bosco D, Berney T, and Berishvili E.
      9. CURRENT DIABETES REPORTS, 2020
        Immunomodulatory Properties of Amniotic Membrane Derivatives and Their Potential in Regenerative Medicine

        Wassmer CH and Berishvili E.
      10. STEM CELL REVIEWS AND REPORTS, 2020
        Treatment of COVID-19 Pneumonia: the Case for Placenta-derived Cell Therapy

        Berishvili E, Kaiser L, Cohen M, Berney T, Scholz H, Floisand Y, and Mattsson J.
      11. MEDICAL SCIENCES, 2020
        Organoïdes sécréteurs d’insuline : des «super-îlots» comme premier pas vers le pancréas bioartificiel
        Lebreton F, Wassmer CH, Bellofatto K, Berney T, and Berishvili E.
      12. CELL TRANSPLANTATION, 2020
        Engineering of Primary Pancreatic Islet Cell Spheroids for Three-dimensional Culture or Transplantation: A Methodological Comparative Study

        Wassmer CH, Bellofatto K, Perez L, Lavallard V, Cottet-Dumoulin D, Ljubicic S, Parnaud G, Bosco D, Berishvili E, and Lebreton F.
      13. CELL4, 2020
        Targeting Toll-Like Receptor 4: a promising strategy to prevent type 1 diabetes occurrence or recurrence

        Alibashe-Ahmed M, Berney T, Giovannoni L, Berishvili E.

PUBLIC REPORTS

VANGUARD continuously reports its results and progress to the European Commission. Some of these reports (called “Deliverables”) are public and once submitted are made available for download here.

  • D9.1 Project website, due 29/02/2020, download available
  • D9.4 VANGUARD Communication Portfolio, due 30/06/2022
  • D2.1 ELSA Training Manual, due 31/12/2022
  • D2.2 Guidelines on ethical, social, legal and psychological aspects of VANGUARD, due 31/12/2022
  • D9.3 VANGUARD Stakeholder Engagement and Dissemination Assessment Reports, due 31/12/2023
  • D9.7 Policy brief, due 31/12/2024
  • D9.8 Final project event and EU Parliament workshop, due 31/12/2024

* Please note that these deliverables are undergoing review and acceptance processes. At this stage this deliverable reflects only the author’s view and the European Commission is not responsible for any use that may be made of the information it contains.