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Issue 916 (04 September 2017)

 

Welcome to BioNews by email, published by the Progress Educational Trust, providing you with news, comment and reviews on genetics, assisted conception, embryo/stem cell research and related areas.

Visit the BioNews website at www.bionews.org.uk where you can subscribe for free to receive BioNews by email in one of three formats, and search the archive of more than 6,000 articles.

 

 

CONTENTS

Comment

News Digest

Reviews

 


 

Scandinavian attitudes to surrogacy – public policy should catch up

04 September 2017

By Sam Everingham

Sam Everingham is the founder of Families Through Surrogacy

Page URL: http://www.bionews.org.uk/page_880957.asp Appeared in BioNews 916

During the planning of the global non-profit Families Through Surrogacy's first educational event on surrogacy in Sweden a few months ago, IVF professionals had suggested inviting a few leading Swedish infertility specialists. Unfortunately none were willing to attend, stymied by Sweden's conservative regulations around surrogacy. Unlike countries such as the UK, Canada, South Africa, Australia, Israel and the US, altruistic surrogacy has never been permitted in Sweden. In 2016 a government task force recommended that this ban be upheld, and Swedes also be blocked from international surrogacy. By contrast, Sweden's National Council on Medical Ethics has said altruistic surrogacy should be permitted.

Peak consumer infertility body Fertility Europe also declined to co-operate, given the political sensitivities around surrogacy. The European Parliament condemned all surrogacy in December 2015, and a year later over 100,000 Europeans even petitioned the Council of Europe to vote against recommended guidelines to safeguard children's rights in relation to surrogacy arrangements, including unresolved issues around legal parentage. This had me worried - was bringing altruistic and compensated surrogates to Stockholm to explain why they had chosen to carry even warranted?

What niggled were two things. Local infertility NGOs were in fact keen to attend, given they had been shrugging off surrogacy questions from infertile couples for many years without any reliable information. Further, research in 2015 showed that despite the absence of domestic access, hundreds of Scandinavians had engaged in overseas surrogacy each year. Sweden was the sixth largest and Norway the third largest user of international surrogacy proportionate to population - an estimated 800 Norwegians and Swedes created families via surrogacy from 2012 – 2014. This is despite a messy process of ensuring legal parentage.

So were those concerned citizens who had petitioned the Council of Europe really representative of community views in Sweden and Norway? To find out, in June 2017 we commissioned a Swedish research firm to conduct an online study of a statistically representative sample of 803 Swedes and Norwegians, aged 18-49 years.

The results showed the majority of participants in both Norway and Sweden were supportive of access to surrogacy in some form (over 80 percent). Compensated surrogacy was more popularly supported than altruistic, though the difference was not statistically significant.

Among the Swedish sample, the majority believed Swedes should be allowed to engage in surrogacy in their home country (89 percent). There was also majority support for the right to access surrogacy in countries which protected women's rights (73 percent), or had supportive surrogacy law in place (65 percent). Significantly fewer believed they should be able to access surrogacy in any foreign country (25 percent).

The Norwegian sample showed very similar results. Most believed they should be allowed to engage in either their home country (90 percent) or a foreign country which protected women's rights (87 percent), or had supportive law in place (72 percent). While there was less support for being able to engage in any foreign country (40 percent), this support was significantly stronger than amongst Swedes.

Within both the Swedish and Norwegian samples, there was equally high levels of support (over 70 percent) for women with a medical need (such as having no uterus) being able to access surrogacy. Support for gay couples accessing surrogacy was significantly lower with around half of each sample supporting this, and support for single men significantly less again (20 percent).

Clearly, amongst Swedish and Norwegian citizens of child-rearing age, there is fairly strong support for surrogacy, where the appropriate protections are in place. The higher level of support for compensated surrogacy may be due to the fact that citizens of these countries have little if any exposure to altruistic surrogacy.

Hence the socially conservative Scandinavian public policy on surrogacy is markedly out-of-step with Swedish and Norwegian community views. The mis-match is evident elsewhere. Australia for example provides no access to legal parentage following cross-border surrogacy. Yet a recent study of Australian community attitudes found close to two-thirds believed that Australians should be allowed to access surrogacy overseas. 

The main political arguments against surrogacy have been feminist concerns about objectification of women's bodies, and concerns about a lack of genuine autonomy in women's decisions. Opponents have typically been concerned to protect children's rights and well-being in the context of uncertainty about possible outcomes.

Certainly community support for social policy reform is inadequate on its own. Consideration of outcomes over time for both surrogates and children is also crucial. Fortunately the UK's Centre for Family Research has been following up such families in the UK for over ten years. Their multiple investigations have consistently shown no harmful effects of surrogacy on the psychological adjustment of either the conceived children or their surrogates.

Hopefully such evidence, in combination with supportive community attitudes, will encourage Scandinavian countries to be more responsive to arguments that surrogacy does not deserve to be forced underground. Instead, Scandinavia needs to hear far more from surrogates about why they choose to give couples the gift of parenthood. Only through such dialogue and understanding can falsehoods that 'all surrogacy is exploitation' be corrected and social policy reformed.
 

SOURCES & REFERENCES

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

04 December 2017 - by Jennifer Willows 
Of Kith and Kin is a play about surrogacy that seems to have very little to say about surrogacy...

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FDA crackdown on unproven stem cell therapies

04 September 2017

By Rikita Patel

Page URL: http://www.bionews.org.uk/page_880539.asp Appeared in BioNews 916

The US Food and Drug Administration (FDA) intends to investigate the use of unproven stem cell therapies being offered in the country's clinics.

Tighter enforcement from the FDA comes as an inspection at StemImmune Inc based in San Diego, California, revealed the use of potentially dangerous treatments administered to vulnerable cancer patients.

Only a small number of stem cell treatments are currently FDA approved, including use of bone marrow transplants in cancer patients and cord blood for specific blood-related disorders. However stem cell treatments using only the patient's own cells are not subject to the same level of regulation as drugs if the cells are only 'minimally manipulated'.

FDA commissioner Dr Scott Gottlieb said in a statement: 'The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'

Five vials, each containing 100 doses of the live Vaccinia Virus Vaccine, were seized from StemImmune Inc by US marshals on 25 August 2017. 

The vaccine, which is used against smallpox, and is not commercially available – was combined with stem cells derived from body fat to create an unapproved therapy. The concoction was injected directly into tumours of cancer patients at California Stem Cell Treatment Centres in Rancho Mirage and Beverly Hills.

The effects of the vaccine in immunocompromised cancer patients have the possibility to cause severe complications such as inflammation and swelling of the heart and surrounding tissues.

In a separate case, a warning letter was also sent to chief scientific officer Kristin Comella at US Stem Cell Clinic in Sunrise, Florida, after three patients with macular degeneration were blinded following the use of unapproved stem cell injections into their eyes, in a sponsored study (see BioNews 893). The letter lists a number of non-compliance to procedures and 'significant deviations' to current good manufacturing practice and good tissue practice.

'Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk,' Dr Gottlieb commented. 'I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch – a safety reporting programme.'

Professionals in the field blame the past lack of FDA attention for the widespread problem and are calling for stringent regulation. Professor Leigh Turner, from the Centre for Bioethics at the University of Minnesota, told CNN: 'This is a space where the FDA could have taken action four or five years ago as far as making this a policy priority.'

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

20 November 2017 - by Martha Henriques 
The US Food and Drug Administration has announced a fast-track review process for gene therapies and other regenerative medicine treatments...
20 November 2017 - by Dr Patrick Foong 
Stem cell research holds tremendous promise for the treatment of a wide variety of illnesses and conditions, from spinal cord injury to autism. However, much more work is necessary to translate stem cell research into safe and effective therapies...
09 October 2017 - by Jennifer Willows 
The reputation of stem cell research is being undermined by unscrupulous clinics offering unproven therapies, says a report published last week...

10 July 2017 - by Lea Goetz 
International experts are calling for global action on unproven and potentially dangerous stem cell therapies and their misleading marketing to the public...
02 May 2017 - by Cathal Farrell 
The ability of stem cells to divide into different mature cell types has ignited the field of regenerative medicine. Stem cells promise to repair and regenerate damaged or diseased tissues without the need for orthodox medical or surgical interventions. However, there is disparity between the expectations held by the general public and some medical professionals versus the reality of the emerging clinical evidence...
20 March 2017 - by Paul Waldron 
In two different attempts to treat degenerative eye diseases with stem cells, three patients have been blinded, while disease progression has been stopped in a separate patient...
12 December 2016 - by Rachel Siden 
Stem cell therapies could be granted accelerated approval by the US Food and Drug Administration as part of a new bill passed by the Senate last week...
21 September 2015 - by Paul Waldron 
The Food and Drug Administration must do more to control clinics offering unproven stem cell treatments in the USA, say scientists....

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New imaging technique could help pick embryos for IVF

04 September 2017

By Anna Leida

Page URL: http://www.bionews.org.uk/page_880511.asp Appeared in BioNews 916

A new imaging technique can help assess the quality of early-stage embryos.

Termed hyperspectral imaging, the technique could one day improve IVF success rates by providing an objective assessment of embryo health, which currently depends on the opinion and experience of the clinician.

'Preimplantation genetic screening of embryos generally takes place under a normal optical microscope,' said lead author Dr Melanie Sutton-McDowall of the University of Adelaide, Australia. 'Although it's quite easy to discern poor embryos (due to differences in uniformity), it is far harder for the clinician to determine objectively, the viability of the other embryos.'

Developed by researchers at the ARC Centre of Excellence for Nanoscale BioPhotonics at the University of Adelaide, the imaging technique is able to identify variations in metabolic activity in cultivated embryos. Metabolic activity is considered one of the most important factors to determine embryo health, and embryos with a homogenous metabolic profile are typically the most healthy.

In this study, published in Human Reproduction, the scientists could detect metabolic differences between five-day-old cow embryos exposed to two different oxygen concentrations (20 percent and 7 percent) using hyper spectral imaging, in contrast to traditional fluorescence microscopic techniques. Each set of embryos subsequently showed different levels of developmental success.

Current techniques can measure the light (fluorescence) naturally produced by cells during chemical reactions, but hyperspectral imaging can measure light intensity across a range of wavelengths. This means it can capture information from several processes simultaneously.

While the use of hyperspectral imaging in IVF clinics and for human embryos is some years away, Dr Sutton-McDowall expects to see the technology adapted for use fairly quickly.

'I think we’ll see this innovative approach commercialized fairly quickly,' she predicted. 'IVF is a costly and complex treatment. Any new method that can help improve the odds of women successfully having babies is of benefit to both clinicians and their patients.'

Various kinds of microscopic systems are already used to provide non-invasive, time-lapse information of growing embryos in the IVF clinic (see Bionews 705).

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

06 November 2017 - by Helen Robertson 
Using just one embryo during IVF results in a much higher chance of a healthy pregnancy and birth, according to a study presented at the annual meeting of the American Society for Reproductive Medicine...

24 July 2017 - by Dr Rachel Huddart 
US scientists have dramatically improved the in vitro maturation of pig egg cells, offering the possibility that similar successes could be achieved in humans...
13 April 2015 - by Dr Rachel Brown 
The first baby in Europe has been born following a new IVF-based technique developed to prevent the inheritance of genetic disorders...
20 May 2013 - by Emma Stoye 
A technique for monitoring embryo health could increase the chance of IVF couples having a healthy baby, according to a study from researchers at a private fertility clinic...
22 August 2011 - by Dr Lux Fatimathas 
European researchers have shown a correlation between impaired embryo development and the fat levels of mother cows. Exposing eggs to high levels of saturated fatty acids affected the health of embryos produced by fertilising those eggs...

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Screen all chromosomes in prenatal embryo testing, says study

04 September 2017

By Dr Rachel Huddart

Page URL: http://www.bionews.org.uk/page_880370.asp Appeared in BioNews 916

Current prenatal chromosome screening tests could miss rare chromosomal abnormalities and lead to inaccurate results.

Non-invasive prenatal testing (NIPT) analyses fetal DNA in the mother's blood, and is increasingly used to screen embryos for trisomies, which can cause pregnancy complications or serious health conditions. Yet currently, NIPT considers only the chromosome pairs which most commonly have trisomies - 13, 18, 21 and the sex chromosomes - and researchers say this may miss valuable information.

'Extending our analysis to all chromosomes allowed us to identify risk for serious complications and potentially reduce false-positive results for Down syndrome and other genetic conditions,' said senior author Dr Diana Bianchi, director of the National Institute of Child Health and Human Development, USA.

Researchers in the US and Australia set out to investigate how chromosomal abnormalities are being picked up by standard NIPT analyses. NIPT works by comparing counts of chromosomes from fetal DNA with a set of 'reference' chromosomes in the same sample. However, if there is an abnormality in the reference chromosomes, the test may fail or return abnormal results.

The team looked at data from nearly 90,000 pregnancies, of which 627 cases were flagged up as abnormal or borderline by standard NIPT. They found rare trisomies were only detected if all genome data obtained by a NIPT test was analysed.

Out of the 627 cases, they found 399 carried rare trisomies most commonly found in chromosomes 7, 15, 16 and 22, and a considerable proportion of rare trisomies affected reference chromosomes.

'Although these trisomies are relatively rare they can be associated with serious pregnancy health problems,' lead author Dr Mark Pertile at the Murdoch Children’s Research Institute in Melbourne, Australia told the Herald Sun. 'We found that sometimes these chromosomes conditions were affecting only the placenta not the baby and that could impact the normal growth of the pregnancy.'

The researchers were able to combine some of this genetic information with clinical data about pregnancy outcomes. Of 52 cases with rare autosomal trisomies, 22 were linked to early miscarriage.

'Our results suggest that patients be given the option of receiving test results from all 24 chromosomes,' said Dr Pertile.

The study, published in Science Translational Medicine, is the largest of its kind and involved both academic researchers and biotech companies Illumina and GRAIL in Redwood City and Menlo Park, California.

The results of the study have already been translated into clinical practice, with Illumina’s Verfi Plus test and the Victorian Clinical Genetics Service’s Percept test both offering screening of all chromosomes. This should help medical professionals better identify which pregnancies should be closely monitoring and when to offer genetic counselling.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

13 November 2017 - by Dr Barbara Kramarz 
A new prenatal screening method for Down's syndrome, Edwards syndrome and Patau syndromes is safer, more reliable and cheaper than existing approaches, a study has found...
06 November 2017 - by Ruth Retassie 
Genetic testing for cystic fibrosis, fragile X syndrome and spinal muscular atrophy is recommended for all would-be parents by a study in Australia...

06 March 2017 - by Emma Laycock 
The Nuffield Council on Bioethics has called for a ban on using early prenatal testing to find out the sex or sequence the whole genome of the fetus...
06 March 2017 - by Nick Meade 
The Nuffield Council of Bioethics' new report on non-invasive prenatal testing is unnecessarily negative and encroaches on women's reproductive choices...
07 November 2016 - by Dr Rachel Huddart 
A more accurate and safer prenatal test for Down's, Edwards' and Patau's syndromes is to be offered by the NHS from 2018, it has been announced...
18 January 2016 - by Lone Hørlyck 
A new blood test for Down’s syndrome in high-risk women has been recommended for use on the NHS....

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Doubt over human embryo editing study

04 September 2017

By Annabel Slater

Page URL: http://www.bionews.org.uk/page_880477.asp Appeared in BioNews 916

A group of scientists have challenged the landmark study which reported the first successful editing of human embryos for a genetic disease.

In an open-access paper published by bioRxiv, the six scientists say the results of the genome editing study only show an absence of the disease-causing mutation, not a repair.

'There are lots of unanswered questions,' said embryologist Dr Anthony Perry of the University of Bath, who was not one of the six authors.

A team of scientists led by Dr Shoukhrat Mitalipov of the Oregon Health and Science University, Portland, USA made headline news in August (see BioNews 912) when they reported successful correction of a paternal disease-causing mutation in human embryos. The team had injected eggs with both the CRISPR/Cas9 components and sperm carrying the mutation at the same time. An unexpected and key finding of their study was that CRISPR/Cas9 had apparently replaced the disease-causing gene using the maternal gene, rather than the template healthy gene copies provided.

However, Dr Dieter Egli of Columbia University, New York and others say there is no plausible biological mechanism for this to happen. They say it is more likely that CRISPR/Cas9 could have caused a large deletion in the paternal gene, which was self-repaired by the cell but prevented the mutation from showing up in the genetic assay.

Other experts have also expressed their concern. Dr Perry said that after fertilisation, the genomes of the egg and sperm reside at opposite ends of the egg cell within separate membranes.

'It’s very difficult to conceive how recombination can occur between parental genomes across these huge cellular distances,' he said.

Dr Junjiu Huang of Sun Yat-Sen University, China, whose team led the world's first human embryo editing study (see BioNews 799), agreed with this suggestion. He told Science Magazine that while his group's study had shown another gene related to the CRISPR-targeted gene had been used as a template, both genes had been located on the same chromosome.

Another theory suggested by Dr Egli's group is that the embryos developed without contribution from the paternal genes, which can happen in some IVF procedures. Dr Mitalipov's team had shown that the paternal genome was present in only two out of six embryonic stem cell lines made from the genome-edited embryos.

Dr Egli's group intend to submit a further article to Nature.

Dr Mitalipov has released a statement saying his team intended to publish a response to each author's concerns.

'We recognize that these results must be confirmed by additional studies,' said Dr Mitalipov, and 'encourage other scientists to reproduce our findings by conducting their own experiments on human embryos and publishing their results.'


The latest developments in genome editing and embryo research will be discussed at the session 'What Next for Genome Editing? Politics and the Public', at the Progress Educational Trust's upcoming public conference 'Crossing Frontiers: Moving the Boundaries of Human Reproduction'.

The conference is taking place in London on Friday 8 December 2017. Full details - including sessions, speakers and how to book your place - can be found here.

SOURCES & REFERENCES
Nature | 31 August 2017
 
bioRxiv | 28 August 2017
 
The Scientist | 31 August 2017
 
Science Magazine | 31 August 2017
 
New Scientist | 01 September 2017
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

07 August 2017 - by Charlotte Spicer 
Scientists have published their study confirming they are the first to correct a disease-causing mutation in human embryos using genome editing...
31 July 2017 - by Charlotte Spicer 
Scientists in the US may have successfully used genome editing in human embryos to correct disease mutations, according to a report by MIT Technology Review...
13 March 2017 - by Dr Katie Howe 
Chinese scientists have successfully used genome editing to correct mutations in viable human embryos for the first time...
26 September 2016 - by Anneesa Amjad 
A scientist in Sweden has become the first to edit genes in healthy human embryos...

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Stem cells restore neurons in monkey model of Parkinson's disease

04 September 2017

By Caroline Casey

Page URL: http://www.bionews.org.uk/page_880548.asp Appeared in BioNews 916

Neurons derived from human stem cells have successfully been used to treat and relieve symptoms of Parkinson's disease (PD) in a primate animal model.

The dopamine-producing neurons, which are preferentially lost in the disease, were generated from induced pluripotent stem cells from the skin and blood of healthy volunteers and PD patients.

Critically the study, published in Nature, found no evidence of tumour formation (a well-known risk for stem cell therapies) as late as two years after transplantation. The authors also confirmed the transplanted neurons integrated into the monkeys' neural networks, and behaved in a similar way to the host neurons.

Professor Jun Takahashi at Kyoto University, Japan, senior author of the study, described how 'the monkeys became more active after cell transplantation: moved more rapidly and more smoothly, and showed more various type of movements and less tremor'.

'In the primate model, these new transplanted cells effectively replaced those that are typically lost within the brains of people affected by Parkinson's – showing very promising results for transplantation as a possible treatment for the condition,' said Professor David Dexter, deputy research director at Parkinson's UK in London, who was not involved in the research.

The dopaminergic neurons typically lost in PD cause patients to have difficulty initiating movement and develop a consistent baseline tremor, both of which are very debilitating.

Professor Dexter explained: 'Current medication only serves to mask the symptoms of the condition, but makes no changes to the brain cells themselves. These studies show that, should brain cell transplantation become a viable therapy, it has the potential to reverse Parkinson's by replacing the dopamine cells that have been lost – a groundbreaking feat.'

After the success of this pre-clinical study, the authors hope to design and initiate a human clinical trial within the next 15 months.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

11 December 2017 - by Ewa Zotow 
Scientists revealed an innovative method which can be used to transplant blood-forming stem cells directly into the brain...

05 June 2017 - by Emma Lamb 
Two teams of doctors in China are to administer embryonic stem cell therapy from fertilised human embryos to treat different degenerative diseases...
05 December 2016 - by Lone Hørlyck 
Researchers have identified a gene linked to early-onset Parkinson's disease...
10 November 2014 - by Rhys Baker 
Researchers have reversed the effects of Parkinson's disease in rats, using human embryonic stem cells...
20 October 2014 - by Dr Victoria Burchell 
A drug can reverse the effects of two Parkinson's disease-causing mutations in fruit flies, a study reports...
28 May 2014 - by Dr Molly Godfrey 
Stem cells created from a monkey's own skin cells can be transplanted back into the animal without a high risk of tumour formation, researchers have reported...

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First gene therapy for leukaemia approved

04 September 2017

By Meetal Solanki

Page URL: http://www.bionews.org.uk/page_880563.asp Appeared in BioNews 916

The world's first cancer treatment which uses a patient's own genetically modified immune cells has been approved.

The treatment, called Kymriah (tisagenlecleucel), is also the first gene therapy to be approved in the USA by the Food and Drug Administration (FDA).

'We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer,' said FDA commissioner Dr Scott Gottlieb. 'New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses.'

The drug is a treatment for acute lymphoblastic leukaemia (ALL), a type of cancer which causes the bone marrow to produce abnormal B or T lymphocytes (white blood cells). The National Cancer Institute estimates that approximately 3,100 patients aged 20 and younger are diagnosed with ALL each year.

Produced by Novartis, Kymriah is made from the patient's own T lymphocytes, which are filtered from the patient's blood and then genetically modified to include a gene coding for a protein called chimeric antigen receptor (CAR). The so-called CAR-T cells are then injected back in the patient, where they are able to recognise and destroy leukaemic B cells.

Kymriah has an advantage over traditional chemotherapy as it does not attack the patient's healthy cells and weaken the body's natural defences. Clinical trials with 63 paediatric and young adult patients with relapsed ALL showed an 83 percent overall remission rate within three months of treatment.

Subsequently, the FDA has approved Kymriah for ALL patients over 25 who have relapsed or have not responded to other treatments.

'Not only does Kymriah provide [patients] with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials,' said Dr Peter Marks, director of the FDA's Centre for Biologics Evaluation and Research.

However the drug does have potentially life-threatening side effects, including inflammation and destruction of normal B cells which leaves patients prone to infections. The FDA requires hospitals that dispense Kymriah be specially certified to treat such side effects.

Although delivered as a one-time dose, Kymriah is priced at US $475,000. Dr Craig Devoe of Northwell Health Cancer Institute, New York, told AFP that he did not think the price was reasonable, and questioned how long treatment would be effective. 'Not just responding but staying in response long term is what patients want,' he said. 'We really don't know how long these cells are going to stay active.'

An application with the European Medicines Agency is expected to be filed by the end of the year, and the FDA may also approve Kymriah to treat lymphoma.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

19 October 2017 - by Jennifer Willows 
The US Food and Drug Administration have approved the world’s second gene therapy to target blood cancer...
25 September 2017 - by Sarah Gregory 
A novel gene therapy can reverse the symptoms and progression of disease in a mouse model of multiple sclerosis...
11 September 2017 - by Ebtehal Moussa 
Two trials assessing gene therapy for blood cancer have been put on hold by the US Food and Drug Administration, following a patient fatality...

17 July 2017 - by Dr Loredana Guglielmi 
A drug for leukaemia that genetically alters patients' own cells to fight cancer, has cleared a critical hurdle in gaining commercial approval...
25 January 2017 - by Dr Loredana Guglielmi 
Doctors at London's Great Ormond Street Hospital have used genome editing to successfully treat two children with leukaemia...
07 December 2016 - by Dr Loredana Guglielmi 
Researchers have developed a stem cell test that could rapidly predict how patients with acute myeloid leukaemia will respond to treatment...
22 February 2016 - by Julianna Photopoulos 
Trials using genetically engineered immune cells have shown 'extraordinary results' in treating blood cancers in terminally ill patients, say researchers...
24 February 2014 - by Chris Hardy 
Researchers trialling a gene therapy-based treatment for leukemia have said the early results go beyond anything they could have thought of in their 'wildest dreams'...

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Actor Sofia Vergara frozen embryo lawsuit dismissed

04 September 2017

By Antony Blackburn-Starza

Page URL: http://www.bionews.org.uk/page_880568.asp Appeared in BioNews 916

A Louisiana court has ruled that it has no jurisdiction over the frozen embryo dispute between actor Sofia Vergara and her ex-fiance Nick Loeb, in a move that may end the two-year legal saga between the couple.

Federal Judge Mary Ann Vial Lemmon ruled that the court has no jurisdiction over the embryos since they had been conceived in California and that neither Vegara nor Loeb had any permanent ties to the state of Louisiana.

A 'right-to-life' claim had been filed against Vergara on behalf of the embryos, who were listed as plaintiffs and named Emma and Isabella in court documents. The claim also stated that Vergara's refusal to allow the embryos to be transferred to a surrogate had denied them of their expected inheritance (see BioNews 881).

Granting Vergara's request to dismiss the application, the judge wrote: 'Plaintiffs' claims against Vergara stem from the IVF procedure and related contracts that Vergara and Loeb entered into in California ...Conversations that allegedly occurred in Louisiana regarding the pre-embryos do not establish minimum contacts by Vergara of purposefully availing herself of the privilege of conducting activities within the forum State, thus invoking the benefits and protections of its laws.'

According to TMZ, Judge Lemmon said that Loeb only filed the claim in Louisiana to take advantage of its pro-life laws. Louisiana is the only state that grants rights to embryos to sue or be sued.

Vergara has filed papers in California to block Loeb from taking control over the embryos, which reportedly remain frozen at a Los Angeles fertility clinic. It is not clear whether Loeb, who previously dropped a claim in California, intends to refile.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

12 December 2016 - by Chee Hoe Low 
Star of the US TV show 'Modern Family', Sofia Vergara, is facing a lawsuit in the state of Louisiana that lists her own frozen embryos among the plaintiffs...
14 March 2016 - by Antony Blackburn-Starza 
The US Supreme Court has declined to hear a man's appeal against a ruling that gave his ex-partner a right to use embryos the couple had created together...
23 November 2015 - by Dr Julia Hill 
A San Francisco judge has ruled that the frozen embryos of a divorced couple should be destroyed, despite the protests of the ex-wife...
05 May 2015 - by Dr Victoria Burchell 
The ex-fiancé of Sofía Vergara, star of TV show Modern Family, is suing her for custody of their frozen embryos...

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Podcast Review: Editing the Embryo - removing harmful gene mutations

04 September 2017

By Eleanor Taylor

Page URL: http://www.bionews.org.uk/page_881034.asp Appeared in BioNews 916

As a scientist working in a fertility clinic, my normal everyday work routine is occasionally punctuated by the ripple effect that occurs when reports of a new groundbreaking reproductive technology enters the public consciousness. I am soon inundated with questions from inquisitive patients (as well as my nearest and dearest): what exactly has been developed, could this technology help me, is it safe, is this going to result in the end of civilisation as we know it? You know, the standard curiosities of the mind.

The announcement in August that the genome editing technique CRISPR, had been used to correct a disease-causing mutation in human embryos (see BioNews 912) was no exception. I began sifting through scientific articles and media resources in an attempt to work out what this report potentially meant for my fertility patients and to prepare myself for the inevitable onslaught of questions. One resource that may prove to be particularly useful for enquiring minds, and one which I may recommend to interested patients, is an episode of The Guardian’s Science Weekly Podcast that was specifically dedicated to discussing the wider implications of the newly published CRISPR research.

The 30-minute podcast, entitled 'Editing the embryo: removing harmful gene mutations', simplifies the science behind the most recent CRISPR publication in the journal Nature (02 August 2017) and examines some of the social, ethical and legal issues surrounding the potential use of genome editing in clinical treatment. A happy balance between science and bioethics is achieved by Dr Hannah Devlin, the Guardian’s science correspondent, as she interviews Dr Paula Amato, a reproductive endocrinologist and associate professor of obstetrics and gynecology at the Oregon Health and Science University, USA and Professor Karen Yeung, director of the Centre for Technology, Law and Society at King's College London, UK.

While Dr Amato, co-author of the Nature paper, does an expert job at reducing the science into a widely accessible format and explaining the significance and limitations of the research, I found my thoughts lingering on the safety aspects of the technology. Specifically, how sure can you be that the CRISPR system has not induced any off-target DNA changes? I was also curious whether the CRISPR technology would be implemented in situations where the limits of preimplantation genetic diagnosis (PGD) have been reached or whether CRISPR would eventually supersede PGD to increase the yield of genetically normal embryos?

Confirming CRISPR safety is clearly a dominant issue, however, I was struck by the manner in which routine IVF treatment and PGD seemed to be viewed as entirely safe in the podcast. All individuals born from IVF and PGD are still below 40 years of age and while such technologies thankfully appear to be safe, the development of late-onset effects from such treatment is still a possibility. Furthermore, the occurrence of epigenetic changes during routine assisted conception treatment and the resulting outcome is not fully understood. Safety will always be a worry where the possibility of creating life is concerned.

Professor Yeung steers the focus away from pure science and succinctly explains how human embryo research is regulated in the UK, before tackling some of the ethical dilemmas that are associated with introducing new technologies into clinical practice, especially when that technology involves creating genetic changes that will be passed down to from generation to generation.

The podcast thankfully bypasses many of the 'traditional' ethical arguments that can dominate discussions about new reproductive technologies, and research involving human embryos. The research carried out by Dr Amato and her colleagues involved purposefully creating 'healthy' human embryos, using eggs specifically donated to the research programme. There will always be groups and individuals that find experimentation on human embryos to be morally abhorrent as well as many people who would disagree with providing financial compensation to women who donate their eggs to research, however, focusing on these issues can stall the wider debates surrounding the clinical and social implications of using such technology.

There is also only a minor nod to the notion of eugenics and designer babies; Dr Amato concisely explains how the CRISPR system is unlikely to be the starting point of the feared 'slippery slope' that leads to the preferential selection of for example, intelligence or athleticism, simply due to the complex nature of how these traits are encoded and expressed. There are no doomsday proclamations; the podcast simply consists of three well-informed professionals who are carefully considering the implications of using CRISPR technology in a measured and balanced manner – just what you would expect from the Guardian.

This podcast is a great introduction to the reproductive science arena, where science meets ethical judgment. It may hold particular appeal to those working in the assisted conception field, individuals concerned about passing a genetic condition onto their offspring and those who would enjoy wrestling with a new bioethical conundrum.

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