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VANGUARD publication on Ethics of Early Clinical Trials of Bio-Artificial Organs available online

A new VANGUARD publication has recently been made available in Transplant International. Its name is “Ethics of Early Clinical Trials of Bio-Artificial Organs” and the publication outlines the ethical challenges addressed by Erasmus University Medical Center Rotterdam team. Although the social value of bio-artificial organs can be undoubtedly enormous, the VANGUARD project is also evaluating potential ethical issues related to bio-artificial organs that were raised with the introduction of this novel technology. The full article can be read here:


Regenerative medicine is the new frontier in the field of organ transplantation. Research groups around the world are using regenerative medicine technologies to develop bio-artificial organs for transplantation into human patients. While most of this research is still at the preclinical stage, bio-artificial organ technologies are gearing up for first-in-human clinical trials in the not-too-distant future. What are the ethical conditions under which early-phase clinical research of bio-artificial organs can be conducted safely and responsibly? What lessons can be learned from prior experiences with early-phase clinical trials in adjacent fields of research? This is a Meeting Report of an online international workshop organised in the context of the Horizon 2020-funded VANGUARD project, which is developing a bio-artificial pancreas for the treatment of patients with type 1 diabetes.

VANGUARD publication on Advances and challenges of endocrine pancreas bioengineering available online

A new VANGUARD article has recently been published in Current Opinion in Endocrine and Metabolic Research. “Advances and challenges of endocrine pancreas bioengineering” – Islet transplantation is a valid treatment option for type 1 diabetes patients. Despite the advantages of this intervention, many obstacles limit its efficacy such as the loss of islets during the process and the need for lifelong immunosuppression. This mini-review discusses the advances and recent technologies aiming to improve the outcomes of islet transplantation. The full article can be read here:


β-cell replacement via islet transplantation (IT) is a viable option for the management of patients with type 1 diabetes. Despite good functional results, IT remains limited by the lack of donors, poor revascularization, loss of islets due to inflammation and hypoxia, and the need for lifelong immunosuppression. In this review, we present the recent advances in the field of tissue engineering proposed to overcome these obstacles. The most promising technologies include the use of stem cell-derived β-cells, accessory cells, scaffolds, encapsulation methods, prevascularization techniques as well as alternative transplantation sites. With the ultimate goal of the generation of neovascularized, immune-protected implantable constructs loaded with insulin-secreting cells, these technologies present a promising future for the field.

VANGUARD consortium meeting in Geneva, CH

On June 3-4, the VANGUARD consortium finally met in person after two years of online meetings. The meeting, which took place at the Geneva University Hospital, was an important occasion to discuss the progress of the project and present the latest results of each Work Package.

The UNIGE team also conducted a tour of its lab facilities along with live demonstrations of certain techniques.

We thank the organisers and all participants for their precious contribution and look forward to continuing our fruitful collaboration in the coming months and years.

VANGUARD Ethics Workshop

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?

To discuss these and related topics, our partner Erasmus MC organised a VANGUARD workshop titled Ethics of early clinical trials in regenerative medicine in transplantation in February 2022. This workshop brought together 74 participants and experts in the fields of regenerative medicine and ethics to discuss these ethical challenges. The video below shows the full recording of the VANGUARD Ethics workshop held online, Thursday 3 February 2022 from 16:00-18:00.

New publication on the generation of pre-vascularised organoids

The VANGUARD consortium recently published collaborative work in the journal Transplant International on the generation of pre-vascularised organoids.

The authors from the University of Geneva and the University of Eastern Piedmont show that pre-vascularized islet organoids exhibit enhanced in vitro function compared to native islets, improved engraftment and accelerated vascularization in vivo in a murine model.

The paper is available Open Access on the journal’s website.

Registration is open for the VANGUARD workshop on ethics in regenerative medicine

Registration is now open for VANGUARD’s Online Workshop on the topic of Ethics in regenerative medicine. The event will take place on Thursday the 3rd of February 2022 and start at 16:00 CET.

A panel of experts will discuss ethical challenges that arise with the arrival of bio-engineered organs:

  • 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?

You will have the chance to hear from the key opinion leader in the area of ethics in biomedicine, Professor Jonathan Kimmelman from McGill University.

The workshop will also include insights from the three ongoing projects on regenerative medicine:

  • BRAVE – Biomechanics and regenerative medicine for a one-shot treatment
  • OrganTrans – Controlled Organoids transplantation as enabler for regenerative medicine translation
  • VANGUARD – Bioartificial Pancreas to Cure Type 1 Diabetes

To conclude the meeting, a panel discussion moderated by Dr. Emma Massey (Erasmus Medical Centre) will bring together Prof. Kimmelman, Dr. Antonia Cronin (King’s College London), and Dr. Ekaterine Berishvili (University of Geneva) to further discuss ethical aspects in regenerative medicine.

Please note that registration in advance is required.

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

A new VANGUARD research article on Efficient and safe correction of hemophilia A by lentiviral vector-transduced BOECs in an implantable device has been published in Molecular Therapy, Methods & Clinical Development. The full article can be read online:

Abstract: Hemophilia A (HA) is a rare bleeding disorder caused by deficiency/dysfunction of the FVIII protein. As current therapies based on frequent FVIII infusions are not a definitive cure, long-term expression of FVIII in endothelial cells through lentiviral vector (LV)-mediated gene transfer holds the promise of a one-time treatment. Thus, here we sought to determine whether LV-corrected blood outgrowth endothelial cells (BOECs) implanted through a prevascularized medical device (Cell Pouch) would rescue the bleeding phenotype of HA mice. To this end, BOECs from HA patients and healthy donors were isolated, expanded, and transduced with an LV carrying FVIII driven by an endothelial-specific promoter employing GMP-like procedures. FVIII-corrected HA BOECs were either directly transplanted into the peritoneal cavity or injected into a Cell Pouch implanted subcutaneously in NSG-HA mice. In both cases, FVIII secretion was sufficient to improve the mouse bleeding phenotype. Indeed, FVIII-corrected HA BOECs reached a relatively short-term clinically relevant engraftment being detected up to 16 weeks after transplantation, and their genomic integration profile did not show enrichment for oncogenes, confirming the process safety. Overall, this is the first preclinical study showing the safety and feasibility of transplantation of GMP-like produced LV-corrected BOECs within an implantable device for the long-term treatment of HA.

VANGUARD presented at the SFT Congress

Our coordinator Ekaterine Berishvili took a part in the 2021 Société Francophone de Transplantation (SFT) on December 8 to explain the challenges and to share the progress that was made during the first year and a half of the VANGUARD project.

The SFT congress is now an established event with a 20 years-long tradition. This is the first time after 10 years that the SFT is taking place in Switzerland.

Geneva was a natural choice for the organisation of this year’s SFT Congress, as the Geneva and Lausanne University Hospitals represent a cluster of knowledge with their world-renowned transplantation activities.

We look forward to the next annual Congress in Lyon, on December 13-16 2022.