SynthesisTransplant international : official journal of the European Society for Organ Transplantation2022
Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues.
Synthesis in Transplant international : official journal of the European Society for Organ Transplantation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Who should be included in first-in-human trials? A systematic review of reasons.Journal of translational medicine · 2025Pooled it
- Education and Ethical Guidance for Organ Donation at the End-of-Life: An Ethical Guidance Statement from the Neurocritical Care Society.Neurocritical care · 2026Review
- Engineering hypoimmune stem cell-derived beta cells.Stem cell research & therapy · 2025Review
- Innovative Approaches to Medical Rehabilitation: Regeneration, Immune Training, Homeostasis, and Microbiome Synergy.International journal of molecular sciences · 2025Review
- Construction and Bioengineering of Human Bioprosthetic Ovaries from Cryopreserved Ovarian Tissue.International journal of molecular sciences · 2025Review
- Absorption of Toxicants from the Ocular Surface: Potential Applications in Toxicology.Biomedicines · 2025Review
- The Last Mile in Beta-Cell Replacement Therapy for Type 1 Diabetes: Time to Grow Up.Transplant international : official journal of the European Society for Organ Transplantation · 2025Review
- The Future of Diabetes Care: Exploring the Potential of Bioartificial Pancreas and Do-It-Yourself Artificial Pancreas System Innovations.Pathobiology : journal of immunopathology, molecular and cellular biology · 2025Review
- Clinical Translation and Implementation of a Bioartificial Pancreas Therapy: A Qualitative Study Exploring the Perspectives of People With Type 1 Diabetes.Transplantation direct · 2024Article
- Region-Specific Decellularization of Porcine Uterine Tube Extracellular Matrix: A New Approach for Reproductive Tissue-Engineering Applications.Biomimetics (Basel, Switzerland) · 2024Article
- ESOT Roadmap for Advanced Therapy Medicinal Products in Transplantation: Navigating Regulatory Challenges to Enhance Access and Care.Transplant international : official journal of the European Society for Organ Transplantation · 2024Review
- Review
- Clinical Translation of Bio-Artificial Pancreas Therapies: Ethical, Legal and Psychosocial Interdisciplinary Considerations and Key Recommendations.Transplant international : official journal of the European Society for Organ Transplantation · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Regenerative medicine has emerged as a novel alternative solution to organ failure which circumvents the issue of organ shortage. In preclinical research settings bio-artificial organs are being developed. It is anticipated that eventually it will be possible to launch first-in-human transplantation trials to test safety and efficacy in human recipients. In early-phase transplantation trials, however, research participants could be exposed to serious risks, such as toxicity, infections and tumorigenesis. So far, there is no ethical guidance for the safe and responsible design and conduct of early-phase clinical trials of bio-artificial organs. Therefore, research ethics review committees will need to look to related adjacent fields of research, including for example cell-based therapy, for guidance. In this systematic review, we examined the literature on early-phase clinical trials in these adjacent fields and undertook a thematic analysis of relevant ethical points to consider for early-phase clinical trials of transplantable bio-artificial organs. Six themes were identified: cell source, risk-benefit assessment, patient selection, trial design, informed consent, and oversight and accountability. Further empirical research is needed to provide insight in patient perspectives, as this may serve as valuable input in determining the conditions for ethically responsible and acceptable early clinical development of bio-artificial organs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.