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HFEA Gives Permission to Recruit Human Egg Donors for Stem Cell Research Using Egg Sharing System

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Stem cell researchers in North East England have been given permission to recruit human egg donors for stem cell research using an existing clinical practice known as egg sharing.

Under the egg sharing scheme, the research team would contribute to the cost of a patient's IVF treatment in return for the donation of some of her eggs.

The material would be used in a field of stem cell research known as nuclear transfer, or therapeutic cloning.

The team, from the North East England Stem Cell Institute (NESCI), anticipates the move will lead to an increase in the number of eggs for research, allowing faster progress to be made towards stem cell therapies for conditions such as diabetes, Alzheimer's Disease and Parkinson's Disease.

The NESCI team is the first in the UK to be offered permission to operate egg sharing for research purposes by the regulatory body the Human Fertilisation and Embryology Authority (HFEA). The team's local ethics committee has already granted permission.

However, it will be at least 12 months before the scheme is in operation as the research team now needs funding to make it work.

It needed to have the regulatory agreement in place before applications could be made for financial backing.

The HFEA offer represents a variation of an existing license awarded in 2004 to Alison Murdoch, Professor of Reproductive Medicine at Newcastle and director of the Newcastle NHS Fertility Centre at LIFE.

This permitted researchers to use, with patient consent, 'failed to fertilize' eggs from patients having IVF treatment and women undergoing follicle reduction for fertility treatment.

One of these eggs was used to create a human blastocyst after nuclear transfer, an early-stage cloned human embryo, now recognized as a world-first and reported in a scientific journal in 2005.

In 2005 the team gained approval from the local ethics committee and the HFEA to ask IVF patients to donate two fresh eggs to research if they had 12 eggs collected for their treatment.

Researchers say, however, the number of eggs donated is too small to allow the work to progress rapidly, and existing practice provided only 66 eggs in seven months.

Research suggests that nuclear transfer is only likely to be successful if eggs are 'fresh' - used immediately after they have been taken from the women.

Egg sharing has been in operation in fertility clinics for 10 years with HFEA approval.

This involves women who are undergoing IVF treatment sharing their eggs with another woman.

The recipient pays for most of the donor's treatment. Thus the donor is able to have IVF treatment which she might otherwise not be able to afford.

In 'egg sharing for research', the woman will receive treatment at a reduced cost in return for donation of some eggs.

In this case, the patients will be recruited from women undergoing fertility treatment at the Newcastle NHS Fertility Centre at Life and the scientific work will be carried out by scientists at Newcastle and Durham Universities.

Professor Murdoch said, "We are extremely pleased with the HFEA's decision, which is a step forward for stem cell research and medicine generally."

"Volunteers have been essential to medical research for many years and this is just another way of engaging volunteers in a research project."

"Like all UK research, it will be strictly regulated at a local and national level by ethics committees and the principals of research governance."

"In Newcastle our fertility patients already take part in a thorough consultation before deciding whether to donate their eggs."

"Our experience is that these patients understand the benefits of our research, and the majority are very keen to participate."

"Of course, it is of paramount importance to ensure that all donors are not recruited to participate in this research against their best interest by coercion or excessive financial inducement."

"All patients involved in egg sharing need IVF treatment to help them have a baby."

"We are helping them to have treatment they may not otherwise be able to afford. There is no additional physical risk to the woman as a result of egg sharing."

She added, "We should point out that, at this stage, we are not offering great promises to patients who may benefit from stem cell therapies."

"There are many scientific difficulties to be overcome in this research before we will be able to translate stem cell science into new treatments."

"However, obtaining more eggs for research will help us to overcome these at a much faster rate than we are doing at the moment."

The HFEA announced it is to develop guidance on whether it is appropriate for women to donate their eggs for use in scientific research with plans for a full consultation from September onwards.

It has requested that the NESCI team provide regular information on its progress to feed in to the consultation process.