mitoHOPE pilot program: Mito Community Summit 2024

Introduction of key speakers and their roles

• Clare Stuart introduces Professor John Carroll, Director of the Monash Biomedicine Discovery Institute, focusing on his work with mitochondria in egg and embryo development.
• Professor John Christodoulou is introduced as the founding director of the Mito Foundation and a member of the scientific and medical advisory panel, now focused on clinical research.
• Professor Catherine Mills from the Monash Bioethics Center is introduced, highlighting her background in philosophy and her research on ethical issues in human reproduction.
• Clare mentions that Catherine leads a stream of work in the mitoHOPE program, focusing on ethical issues and community input.

Overview of mitoHOPE project

• Professor Carroll thanks the Mito Foundation for the invitation and introduces the mitoHOPE project, aiming to eliminate the risk of inheriting mitochondrial genetic disease.
• The project aims to introduce mitochondrial donation safely and efficiently in Australia, with a focus on healthy outcomes, pilot, and evaluation.
• Acknowledgment of meeting on the lands of the Kulin Nations and the role of the Mito Foundation and the Bloody Long Walk in raising funds and bringing the research community together.
• The mitoHOPE team includes members from Monash University, Murdoch Children’s Research Institute, Melbourne University, Adelaide, and the University of Newcastle, UK.

Explanation of mitochondrial donation

• Professor Carroll explains mitochondrial donation as an IVF-based technique involving a one-cell embryo with nuclear DNA from parents and mitochondria from a donor egg.
• The process involves donating the embryo’s mitochondria from a donor egg to the nucleus of the parent embryo, resulting in a healthy embryo.
• The technique aims to produce babies without mitochondrial genetic disease, with a movie demonstration at the end.
• The journey to this point started in the UK with legislation in 2015, followed by advocacy in Australia, leading to the introduction of legislation in 2021.

Legislation and Funding for mitoHOPE Project

• Professor Carroll discusses the legislative process in Australia, including public consultation, Senate committee inquiries, and the introduction of Maeve’s Law in 2021.
• The Australian government provided funding for mitochondrial donation in March 2023, with the mitoHOPE Project awarded funding in June 2023.
• The program focuses on healthy outcomes, pilot, and evaluation, with a community-driven approach.
• Professor Mary Herbert from the University of Newcastle is critical in the team, responsible for introducing mitochondrial donation in the UK.

Steps and regulatory process for mitoHOPE project

• Professor Carroll outlines the three main steps for the mitoHOPE project: demonstrating mitochondrial donation in Australia, preparing for the clinical trial, and undertaking the clinical trial.
• Each step requires approval from an ethics committee and the embryo research licensing committee.
• The process involves multiple stages, including pre-clinical research, clinical trial research and training, and the clinical trial itself.
• The goal is to have the first license approved by early 2025 to start the clinical trial in 2025.

Clinical trial planning and recruitment

• Professor Christodoulou discusses the complex process of activating the clinical trial, including trial design, recruitment, mitochondrial donation, and IVF procedures.
• The mito community’s input has been crucial in designing the clinical trial, with a focus on keeping local medical teams involved
• A clinical network has been established around the country to provide support for individuals with mitochondrial disease.
• The importance of genetic counseling and assessing the health and fitness of women undergoing the process is emphasized.

Community engagement and implementation in mitoHOPE

• Professor Mills introduces the community engagement and implementation stream of the mitoHOPE program, focusing on social research to improve the program’s experience.
• The research aims to understand the social expectations and acceptability of mitochondrial donation.
• A large public attitude survey found high levels of support for mitochondrial donation and funding through Medicare.
• Citizens’ juries in regional and urban areas confirmed strong support for public funding without co-payments.

Focus Groups and Future Research

• Professor Mills discusses focus groups to understand the psychosocial needs of people going through the clinical trial, leading to the appointment of a case manager or family advocate.
• Research on egg donation found that over 50% of people were willing to donate eggs, with 90% more willing if their nuclear DNA was not involved.
• Future engagement includes deep interviews with trial participants and research with the Mito community in the UK to learn from their experiences.
• The goal is to continuously improve the trial and ensure the research has direct benefits to the program.