What is mitochondrial donation?

Mitochondrial donation is an IVF-based technique that offers real hope for families with certain forms of mitochondrial disease (mito) to have healthy children of their own.

Eligible Australian women with a genetic diagnosis of mitochondrial DNA disease will soon have access to mitochondrial donation under a pilot program. The technique involves removing the nuclear DNA from a patient’s egg containing faulty mitochondria and inserting it into a healthy donor egg, which has had its nuclear DNA removed.

As the nuclear DNA is retained, the unique genetic information (that makes us who we are and determines what we look like) is passed on from mother to child, but the mitochondrial defects are not.

The Mitochondrial Donation Law Reform (Maeve’s Law) Act 2021  was passed in the Senate on Wednesday 30 March 2022. This marked a historic moment for the Australian parliament and an enormous milestone for the mito community.

The passage of Maeve’s Law is the culmination of many years of advocacy and an inspiring example of the mito community working together. We thank all families who bravely shared their personal stories, met with parliamentarians, and made heartfelt submissions. Your courage and tenacity made this milestone possible.

Read more about the journey to legalise mitochondrial donation.

What has happened since Maeve’s Law was passed in 2022?

On 2 March 2023, the Australian Government announced that a Monash University led project team would receive $15 million to conduct a pilot program for mitochondrial donation. This funding has been awarded from Australia’s Medical Research Future Fund (MRFF). The project has been named mitoHOPE.

The pilot program will build evidence of the safety, efficacy, and feasibility of implementing mitochondrial donation in clinical practice settings. It also includes a research program that is refining and improving the techniques available.

The mitoHOPE team closely considered Our Voice: Mito community priorities for the Australian mitochondrial donation pilot when developing the grant application. As a partner in this project, Mito Foundation is collaborating with Monash University, Monash IVF, Murdoch Children’s Research Institute, and other partner organisations.

The Australian Government has also created the licensing scheme and ethical guidelines, both important foundations for the pilot stage.

Mito Foundation has been working with researchers to influence the design of the pilot program to ensure that it meets the needs of the mito community. This includes when people from around Australia will be able to access mitochondrial donation and how the pilot program will work with other health care services.

The mitoHOPE team has also spoken with members of the mito community. Their aim is to learn about the supports needed for prospective parents who are looking to grow their family with mitochondrial donation. Thank you to everyone who participated in this research. There will be more opportunities to contribute to mitoHOPE in the future. Please keep an eye on our communications for updates.

If you would like to learn more about the pilot program, please visit the mitoHOPE website.

Who could mitochondrial donation be an option for?

Mitochondrial donation is an option that may be suitable for a prospective mother who has a genetic change in her mitochondrial DNA. The genetic change must be known to cause serious mito.

Mitochondrial donation will not be an option for families impacted by mito when:

  • the genetic change that causes their mito has not been found.
  • the genetic change that causes their mito has been found in their nuclear DNA.

Click the button below to read more about the different reproductive options for families affected by mito who are thinking about having children.

Prospective parents should discuss options with a genetic counsellor. They could also speak to other members of their health care team.

If mitochondrial donation is appropriate, the mitoHOPE team will work with prospective parents to apply for approval. The embryo research licensing committee (ERLC) determines these approvals. The pilot program may also have criteria, such as being eligible for Medicare.

When will Australians be able to use mitochondrial donation?

mitoHOPE will be able to start enrolling prospective parents in the pilot program soon. Our best estimate is that this should occur in early 2025.

The team has made progress. In March 2024, the project received an approval from a research ethics committee for preclinical research and training. The project is now waiting for licenses from the ERLC.  These licenses will allow the team to start training embryologists using human eggs.

When the embryologists are able to demonstrate they can do mitochondrial donation in the lab on human cells, the mitoHOPE team can then seek approvals for the clinical trial. This will again need approvals from a research ethics committee and a license from the ERLC.

It is difficult to tell how long all this will take. The mitoHOPE team are hopeful of recruiting the first participants in early 2025.

What can I do while I wait?

If you are interested in mitochondrial donation here are some things you can do while you wait.

Where can I go for more information

Where can I go for more information?

You can find out more by contacting the Mito Foundation Helpline. Our team can help you to understand your options based on your individual situation.