13 research outputs found
The bio-artificial pancreas to treat type 1 diabetes:Perspectives from healthcare professionals in the Netherlands
Aims: Healthcare professionals are relevant stakeholders because of their gatekeeper role in the clinic. This studyaims to explore their perspectives on the potential future clinical implementation of the bio-artificial pancreas(BAP) for people with type 1 diabetes, and suitable target groups.Methods: Semi-structured interviews were conducted with 17 healthcare professionals, including endocrinologists, nurses, and pancreas transplant surgeons. Inclusion was stopped once data saturation was reached. Theaudiotaped interviews were transcribed verbatim. Qualitative content analysis using an inductive approach wasconducted to develop themes within a coding framework.Results: Three main themes emerged: (1) hoped-for benefits, which included improved clinical outcomes,enhanced sense of normality, reduced mental burden for patients and their significant others, greater societalparticipation, and lower costs; (2) concerns, which included safety and effectiveness, inequitable access, accurateinformation, control over self-management, and organizational challenges; and (3) allocating the BAP duringinitial implementation, which included prioritizing people who lack effective treatment options, people withmental health issues, and vulnerable people.Conclusions: The results of this study are important for researchers and practitioners involved in the developmentof the BAP, so that they can align its design and the process of clinical implementation with healthcare professionals’ perspectives
Early-Phase Clinical Trials of Bio-Artificial Organ Technology:A Systematic Review of Ethical Issues
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
Clinical Translation of Bio-Artificial Pancreas Therapies:Ethical, Legal and Psychosocial Interdisciplinary Considerations and Key Recommendations
The field of regenerative medicine offers potential therapies for Type 1 Diabetes, whereby metabolically active cellular components are combined with synthetic medical devices. These therapies are sometimes referred to as “bioartificial pancreases.” For these emerging and rapidly developing therapies to be clinically translated to patients, researchers must overcome not just scientific hurdles, but also navigate complex legal, ethical and psychosocial issues. In this article, we first provide an introductory overview of the key legal, ethical and psychosocial considerations identified in the existing literature and identify areas where research is currently lacking. We then highlight two principal areas of concern in which these discrete disciplines significantly overlap: 1) individual autonomy and 2) access and equality. Using the example of beta-cell provenance, we demonstrate how, by harnessing an interdisciplinary approach we can address these key areas of concern. Moreover, we provide practical recommendations to researchers, clinicians, and policymakers which will help to facilitate the clinical translation of this cutting-edge technology for Type 1 Diabetes patients. Finally, we emphasize the importance of exploring patient perspectives to ensure their responsible and acceptable translation from bench to body.</p
Older patients' experiences with and attitudes towards an oncogeriatric pathway: A qualitative study
INTRODUCTION: To tailor treatment for older patients with cancer, an oncogeriatric care pathway has been developed in the Leiden University Medical Center. In this care pathway a geriatric assessment is performed and preferences concerning cancer treatment options are discussed. This study aimed to explore patient experiences with and attitudes towards this pathway.MATERIALS AND METHODS: A qualitative study was performed using an exploratory descriptive approach. Individual face-to-face semi-structured interviews were conducted with older patients (≥70 years) who had followed the oncogeriatric care pathway in the six months prior to the interview. The interviews were audio-recorded and transcribed verbatim. The transcripts were analyzed inductively using thematic analysis.RESULTS: After interviews with 14 patients with a median age of 80 years, three main themes were identified. (1) Patients' positive experiences with the oncogeriatric pathway: Patients appreciated the attitudes of the healthcare professionals and felt heard and understood. (2) Unmet information needs about the oncogeriatric care pathway: Patients experienced a lack of information about the aim and process. (3) Incomplete information for decision-making: Most patients were satisfied with decision-making process. However, treatment decisions had often been made before oncogeriatric consultation. No explicit naming and explaining of different available treatment options had been provided, nor had risk of physical or cognitive decline during and after treatment been addressed.DISCUSSION: Older patients had predominately positive attitudes towards the oncogeriatric care pathway. Most patients were satisfied with the treatment decision. Providing information on the aim and process of the care pathway, available treatment options, and treatment-related risks of cognitive and physical decline may further improve the oncogeriatric care pathway and the decision-making process.</p
Older patients' experiences with and attitudes towards an oncogeriatric pathway: A qualitative study
INTRODUCTION: To tailor treatment for older patients with cancer, an oncogeriatric care pathway has been developed in the Leiden University Medical Center. In this care pathway a geriatric assessment is performed and preferences concerning cancer treatment options are discussed. This study aimed to explore patient experiences with and attitudes towards this pathway.MATERIALS AND METHODS: A qualitative study was performed using an exploratory descriptive approach. Individual face-to-face semi-structured interviews were conducted with older patients (≥70 years) who had followed the oncogeriatric care pathway in the six months prior to the interview. The interviews were audio-recorded and transcribed verbatim. The transcripts were analyzed inductively using thematic analysis.RESULTS: After interviews with 14 patients with a median age of 80 years, three main themes were identified. (1) Patients' positive experiences with the oncogeriatric pathway: Patients appreciated the attitudes of the healthcare professionals and felt heard and understood. (2) Unmet information needs about the oncogeriatric care pathway: Patients experienced a lack of information about the aim and process. (3) Incomplete information for decision-making: Most patients were satisfied with decision-making process. However, treatment decisions had often been made before oncogeriatric consultation. No explicit naming and explaining of different available treatment options had been provided, nor had risk of physical or cognitive decline during and after treatment been addressed.DISCUSSION: Older patients had predominately positive attitudes towards the oncogeriatric care pathway. Most patients were satisfied with the treatment decision. Providing information on the aim and process of the care pathway, available treatment options, and treatment-related risks of cognitive and physical decline may further improve the oncogeriatric care pathway and the decision-making process.</p
The Relevance of Advanced Therapy Medicinal Products in the Field of Transplantation and the Need for Academic Research Access:Overcoming Bottlenecks and Claiming a New Time
The field of transplantation has witnessed the emergence of Advanced Therapy Medicinal Products (ATMPs) as highly promising solutions to address the challenges associated with organ and tissue transplantation. ATMPs encompass gene therapy, cell therapy, and tissue-engineered products, hold immense potential for breakthroughs in overcoming the obstacles of rejection and the limited availability of donor organs. However, the development and academic research access to ATMPs face significant bottlenecks that hinder progress. This opinion paper emphasizes the importance of addressing bottlenecks in the development and academic research access to ATMPs by implementing several key strategies. These include the establishment of streamlined regulatory processes, securing increased funding for ATMP research, fostering collaborations and partnerships, setting up centralized ATMP facilities, and actively engaging with patient groups. Advocacy at the policy level is essential to provide support for the development and accessibility of ATMPs, thereby driving advancements in transplantation and enhancing patient outcomes. By adopting these strategies, the field of transplantation can pave the way for the introduction of innovative and efficacious ATMP therapies, while simultaneously fostering a nurturing environment for academic research.</p
An ethical perspective on the social value of cell-based technologies in type 1 diabetes
Regenerative medicine is set to revolutionize the treatment of type 1 diabetes. Using cell-based technologies, it seeks to restore within the patient’s body the function of pancreatic islets cells in regulating glucose. Various (stem) cell-based products are currently being developed that can be implanted in type 1 diabetes patients to produce and secrete insulin. However, clinical translation of these cell-based technologies will take time, effort and resources. Moreover, it will expose clinical trial participations to the risks and harms associated with – especially early-phase – clinical research. To ethically justify the risks incurred by research participants and the allocation of – inevitably scarce – resources in biomedical research, new medical technologies must have social value. To determine social value, it does not suffice to assess the safety and efficacy of (stem) cell-based technologies for treatment of type 1 diabetes in isolation. Rather, the added benefit of the technology should be established in comparison to existing treatment modalities – i.e., in type 1 diabetes care, to device-based treatments, and islet or pancreas transplantation. This chapter offers an analysis of the potential value of cell-based technologies in four ethical dimensions: beneficence, autonomy, privacy, and justice. To achieve these various forms of social value, stakeholder groups should carefully consider patient selection, and ensure affordability and accessibility, also in resource-constrained healthcare settings. Only then will cell-based technologies come to benefit patients with type 1 diabetes who may need them most
An ethical perspective on the social value of cell-based technologies in type 1 diabetes
Regenerative medicine is set to revolutionize the treatment of type 1 diabetes. Using cell-based technologies, it seeks to restore within the patient’s body the function of pancreatic islets cells in regulating glucose. Various (stem) cell-based products are currently being developed that can be implanted in type 1 diabetes patients to produce and secrete insulin. However, clinical translation of these cell-based technologies will take time, effort and resources. Moreover, it will expose clinical trial participations to the risks and harms associated with – especially early-phase – clinical research. To ethically justify the risks incurred by research participants and the allocation of – inevitably scarce – resources in biomedical research, new medical technologies must have social value. To determine social value, it does not suffice to assess the safety and efficacy of (stem) cell-based technologies for treatment of type 1 diabetes in isolation. Rather, the added benefit of the technology should be established in comparison to existing treatment modalities – i.e., in type 1 diabetes care, to device-based treatments, and islet or pancreas transplantation. This chapter offers an analysis of the potential value of cell-based technologies in four ethical dimensions: beneficence, autonomy, privacy, and justice. To achieve these various forms of social value, stakeholder groups should carefully consider patient selection, and ensure affordability and accessibility, also in resource-constrained healthcare settings. Only then will cell-based technologies come to benefit patients with type 1 diabetes who may need them most
Organoids: a systematic review of ethical issues
Organoids are 3D structures grown from pluripotent stem cells derived from human tissue and serve as in vitro miniature models of human organs. Organoids are expected to revolutionize biomedical research and clinical care. However, organoids are not seen as morally neutral. For instance, tissue donors may perceive enduring personal connections with their organoids, setting higher bars for informed consent and patient participation. Also, several organoid sub-types, e.g., brain organoids and human–animal chimeric organoids, have raised controversy. This systematic review provides an overview of ethical discussions as conducted in the scientific literature on organoids. The review covers both research and clinical applications of organoid technology and discusses the topics informed consent, commercialization, personalized medicine, transplantation, brain organoids, chimeras, and gastruloids. It shows that further ethical research is needed especially on organoid transplantation, to help ensure the responsible development and clinical implementation of this technology in this field