International Society for Stem Cell Research

• CLEVELAND, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2023 and provided an update on progress toward achieving key corporate objectives.
• Abeona anticipates submitting the BLA in the third quarter of 2023.
• License and other revenues in the second quarter of 2023 were $3.5 million, compared to $1.0 million in the second quarter of 2022.
• Abeona Therapeutics will host a conference call and webcast today, August 8, 2023, at 8:30 a.m.

• On June 14, 2023, developmental biologist Magdalena Żernicka-Goetz presented her research on creating human embryos using stem cells at the 2023 annual meeting of the International Society for Stem Cell Research (ISSCR).
• Read more:
  Scientists have created synthetic human embryos.

Beyond the limits

• Synthetic human embryos — also called embryoid bodies, embryo-like structures or embryo models — mimic the development of “natural human embryos,” those created by fertilization.
• Read more:
  Creating and implanting synthetic monkey embryos could pave the way to stem-cell babies

  In addition, some maintain that the creation of synthetic human embryos would allow for research beyond the 14-day limit that typically applies to natural human embryos.

Laws in the United Kingdom

• The research presented by Żernicka-Goetz at the ISSCR meeting took place in the United Kingdom.
• It was conducted in accordance with the Human Fertilization and Embryology Act, 1990, with the approval of the U.K.
• This means that synthetic human embryo research beyond 14 days can proceed in the U.K.

Canadian law

• While the law in the U.K. does not apply to synthetic human embryos, the law in Canada clearly does.
• This is because the legal definition of an embryo in Canada is not limited to embryos created by fertilization.
• A synthetic human embryo is a human organism.

Limitations

• Given that the AHR Act applies to synthetic human embryos, there are legal limits on their creation and use in Canada.
• First, human embryos — including synthetic human embryos – can only be created for the purposes of “creating a human being, improving or providing instruction in assisted reproduction procedures.” Given the state of the science, it follows that synthetic human embryos could legally be created for the purpose of improving assisted reproduction procedures.
• Second, “spare” or “excess” human embryos — including synthetic human embryos — originally created for one of the permitted purposes, but no longer wanted for this purpose, can be used for research.

Prospects for expansion

• Alternatively, they may insist there is an important moral distinction between natural and synthetic human embryos because synthetic human embryos lack the potential to become live born humans.
• This means they fall into the category of non-viable human embryos.
• It is not the case, however, that all natural embryos are viable embryos, and that all synthetic embryos are non-viable embryos.
• And one day, synthetic human embryos may be viable embryos.

• Scientists recently announced that they have developed synthetic embryos using just stem cells.
• The work, which is yet to be published in a journal, has prompted a debate about the potential use of embryos derived from stem cells – known as embryo models – in research.
• First, they differ from embryos created by fertilisation, although we don’t yet understand the full extent of the differences from a biological or moral perspective.
• Now we must consider the ethical and moral quandaries

  By contrast, embryo models are created directly from stem cells – either embryonic stem cells previously isolated from an embryo or pluripotent stem cells (cells that have been reprogrammed under laboratory conditions to become stem cells).

An exciting prospect for science

• Research with fertilised embryos is a carefully regulated area of science.
• Notably, research using human embryos must stop no later than the point of 14 days development, before the primitive streak emerges.
• For example, the fact that embryo models don’t require eggs or sperm may mean that they are different to fertilised embryos.

Ethics and regulation

• However, stem cell-derived embryos don’t fit neatly in to this system because the law was drafted before the technology was developed.
• They’re not the same as fertilised embryos – and are probably not “embryos” at all under the legislation.
• At an international level, guidance for research with stem cell-based embryos has been proposed by the International Society for Stem Cell Research.

• SEATTLE, June 16, 2023 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced preclinical data from six presentations, including two oral presentations, at the International Society for Stem Cell Research (ISSCR) 2023 Annual Meeting.
• “Our leading presence at ISSCR showcased key preclinical data generated from our programs using our hypoimmune and fusogen platforms,” said Doug Williams, Ph.D., Sana’s President of Research and Development.
• We also shared data demonstrating in vivo delivery of various genetic payloads to human hematopoietic stem/progenitor cells, highlighting an important capability with the fusogen platform.
• The studies showed that these fully differentiated SC-islets can be delivered intramuscularly with robust function and without the need for bioscaffolding.