Social & Ethical Aspects of the Project
Prenatal stem cell therapy is a field very much in its infancy and the wider application of the technique following successful clinical trials requires an in depth understanding of psychosocial aspects associated with it. We will undertake systematic reviews of literature and develop questionnaires to better understand existing perceptions of this type of treatment. This work will be a collaboration between project partners Karolinska Institutet, Lund University and Great Ormond Street Hospital, each of which bring team members with extensive experience in evaluating these aspects.
Identifying Ethical Concerns ...
A number of ethical issues also arise when considering prenatal stem cell transplantation for OI. These include whether it is ethically sound to offer parents the option of prenatal and/or postnatal transplantation with allogeneic stem cells in severe cases of OI when the prognosis for their child is uncertain and the procedure could provide unrealistic hopes. We also have to consider the ethical implication of whether the child might survive in poor condition after prenatal treatment. In addition we would be using stem cells that have been obtained from fetal tissues after elective termination of pregnancy.
... and Ensuring Oversight
To address these ethical issues, the Department of Medical Ethics at the University of Lund will summarise the present status of the field, examine the risk associated with this therapy and lastly propose ethical criteria for identifying the patient categories that should be approached with information on this treatment and prioritise conflicting interests of different stakeholders (members of Ethical Review Boards, politicians, researchers, clinicians, patient advocates and patients).
Data Safety and Monitoring Board
A Data Safety and Monitoring Board has been installed to follow the progress and quality of the study. This independent Board will review the general progress and feasibility of the trial, the quality and completeness of the data, adverse events and safety and specifically the justification, collection and processing of sensitive data. The Board is the primary data and safety advisory group for the Trial Steering Committee. The chair of the Data Safety and Monitoring Board is Professor Alan W. Flake, MD PhD at the Children's Hospital of Philadelphia, USA. Professor Flake is an internationally recognized leader in fetal diagnosis, surgery and care with vast experience in preclinical stem cell transplant studies.
Ethical Advisory Board
An independent Ethical Advisory Board has been appointed to oversee the project. This board comprises clinical and non-clinical experts in medical ethics. The Board will review ethical aspects of activities within the project to ensure that all experimental work and handling of results is conducted to the highest ethical standards.
Scientific Advisory Board
We will make use of four external scientific advisors who are independent of the BOOSTB4 project Consortium. The advisors will be invited to help guide research directions and discuss results and other issues arising during the course of the project. Their role is to analyse the project's progress, through meeting presentations given by members of the BOOSTB4 Consortium, and to offer independent, impartial advice on potential areas for improvement and new avenues to explore.
The BOOSTB4 study has received, or is in the process of applying for, approvals to proceed from the relevant Competent Authorities and Ethics Committees in each Member State where we will undertake clinical work. We will also follow all applicable regulations governing clinical trials in the Member States.