18 March 2021

Nature paper: Modelling human blastocysts by reprogramming fibroblasts into iBlastoids

Monash University’s Polo Laboratory has published research in Nature, which involved the creation of human-embryo like structures by reprogramming adult human skin cells. These structures are called iBlastoids by the research group because they are artificially induced and closely resemble human blastocysts (an early stage of human embryo development).

iBlastoids are not generated from the fertilisation of an egg by a sperm. They are artificially created by reprogramming adult human skin cells. iBlastoids can be created in large numbers in the laboratory, which is expected to allow researchers to more easily study early human development. In the Australian context, research on early human embryonic development has been limited to using ‘excess’ embryos created during ART treatment. Research opportunities have therefore been limited by the low number of available ‘excess’ embryos, as well as ethical concerns over the use of embryos created by fertilisation in research. 

All research involving human embryos in Australia must meet strict ethical and legislative requirements, overseen by the NHMRC Embryo Research Licensing Committee.

The Committee regulates research activities to ensure compliance with Commonwealth laws that prohibit:
•    the creation and use of human embryos for research unless under licence, and strict licence conditions apply [the Research Involving Human Embryos Act 2002
•    the development of a human embryo outside the body of a woman for more than 14 days [the Prohibition of Human Cloning for Reproduction Act 2002].

NHMRC understands that during its research, the Polo Laboratory adhered to the 14-day rule by not allowing the iBlastoids to develop beyond 11 days. The published research was undertaken with the oversight and approval of the Monash University Human Research Ethics Committee (HREC). The HREC would have considered compliance with the Australian Code for the Responsible Conduct of Research, 2018 and the National Statement on Ethical Conduct in Human Research. When it became evident that the research had produced embryo-like structures, the Monash HREC advised the Polo Laboratory to contact the NHMRC Embryo Research Licensing Committee.

It is the view of the NHMRC Embryo Research Licensing Committee that the iBlastoids meet the definition of a human embryo in the Research Involving Human Embryos Act 2002 (refer part b below). The Act defines a human embryo as a discrete entity that has arisen from either:

a)    the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or

b)    any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;

and has not yet reached 8 weeks of development since the first mitotic division.

The Research Involving Human Embryos Act 2002 requires that research on human embryos can only be conducted under a licence issued by the NHMRC Embryo Research Licensing Committee. The Act also sets out criteria that the Committee must consider before it issues a licence authorising the use of excess ART embryos or the creation and/or use of other embryos.

The Polo Laboratory at Monash University has confirmed its intention to work under an appropriate licence and its conditions for all future research involving iBlastoids.

As the agency within the Commonwealth’s Health portfolio that has responsibility for the legislation, and supports the work of the Embryo Research Licensing Committee, NHMRC will not be providing interviews.
 

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