The California Institute for Regenerative Medicine has awarded nearly US$5m to Dr. Evan Y. Snyder, a professor at the Sanford Burnham Prebys research facility in San Diego.
The funding will allow Snyder to complete pre-investigational new drug-enabling studies, a step toward securing US FDA approval of a human trial for neural stem cells as a potential treatment for newborns who experience oxygen and blood-flow deprivation during birth.
The resultant perinatal hypoxic-ischemic brain injury (HII) can cause cerebral palsy and other permanent neurological disorders.
“In the past 25 years that I have worked with these critically ill newborns, the only treatment advance for HII has been therapeutic hypothermia – or whole-body cooling – to prevent brain damage,” says Snyder, professor and director of the Center for Stem Cells & Regenerative Medicine at Sanford Burnham Prebys.
“When my lab first isolated human neural stem cells in the 1990s, I immediately thought of their potential to help these children.”
Of every 1,000 babies born in the US, two to four experience HII. Possible causes range from umbilical cord compression and disrupted maternal blood pressure to early separation of the placenta from the uterus.
Standard treatment includes therapeutic hypothermia, breathing assistance and life support. Approximately 10 to 20 per cent of affected infants develop cerebral palsy, epilepsy, an intellectual disability or additional permanent neurological disorders.
The subsequent lifelong medical and rehabilitative care is estimated to cost US$1 million per child. Indirect costs based on the impact on family dynamics are estimated to be two to five-fold greater.
“We hope to protect a subset of newborns from developing more serious neurological conditions by focusing on the brain cells that are simply stunned, not destroyed, from the insult – and hence potentially salvageable,” says Snyder.
“If we augment the injured area with neural stem cells, we may be able to restore some balance to the injured region. We might be able to rescue some of the nerve cells that are hanging on the precipice between life and death, and perhaps help infants reach their developmental milestones.”
Snyder first isolated human neural stem cells in 1998, a landmark discovery for the stem cell field. Over the past two decades, human neural stem cells have been tested extensively for their therapeutic potential.
The cells have been studied in animal models of Parkinson’s disease, amyotrophic lateral sclerosis (ALS), spinal cord injury and childhood neurodegenerative diseases.
Related human neural stem cells have been evaluated in clinical trials for adult brain tumours.
“These cells are exceptionally well characterised,” says Snyder. “We know that they are drawn to injured regions like a magnet, we know they make a cocktail of healing factors and we know they soak up toxins in damaged areas. These characteristics make them very promising therapies, particularly for the developing paediatric brain.”
The grant will allow Snyder and his team to conduct animal studies to determine the optimal dose, location and timing to introduce neural stem cells to rescue at-risk brain cells.
At the end of the project, which is anticipated to take 2.5 years, Snyder plans to present to the FDA.
He hopes to next launch a Phase 1b/2a clinical trial in newborns with HII to evaluate the neuroprotective effects of human neural stem cells.
“Today, we cross an important threshold,” says Snyder. “We are one step closer to a future where we may be able to protect some newborns from an unanticipated birth injury – and help parents give their children the best possible start in the world.”
No higher risk of pregnancy complications in women with MS – study
Women with multiple sclerosis (MS) may not be at a higher risk of pregnancy complications like gestational diabetes, emergency caesarean section or stillbirth than women who do not have the disease, new research has found.
However, the study did find that babies born to mothers with MS had a higher chance of being delivered by elective caesarean section (c-section) or induced delivery, and of being small for their age when compared to babies of women who did not have the disease.
“Women with multiple sclerosis may be understandably concerned about the risks of pregnancy,” says study author Professor Melinda Magyari, of the University of Copenhagen.
“While previous research has shown there is no higher risk of birth defects for babies born to women with MS, there are still a lot of unknowns around pregnancy and MS.
“We wanted to find out if women with MS are at risk for a variety of pregnancy complications.
“We found overall their pregnancies were just as healthy as those of the mothers without MS.”
The study involved 2,930 pregnant women with MS who were compared to 56,958 pregnant women without MS. All women gave birth between 1997 and 2016.
Researchers found no difference in risk of several pregnancy complications between women with MS and women without it.
No differences were found in risk of pre-eclampsia, gestational diabetes, placenta complications, emergency c-section, instrumental delivery, stillbirth, pre-term birth, congenital malformations or low Apgar score. Apgar score is a test of a newborn’s health, including measures like heart rate, reflexes and muscle tone immediately after birth.
Researchers did find that 401 of the 2,930 women with MS, or 14 per cent, had an elective c-section, compared to 4,402 of the 56, 958 women without MS, or eight per cent, who had an elective c-section.
After adjusting for other factors that could increase the likelihood of having an elective c-section, such as prior c-section and mother’s age, women with MS were 89 per cent more likely to have an elective c-section.
Researchers also found women with MS were 15 per cent more likely to have an induced delivery than women without the disease.
Also, women with MS were found to be 29 per cent more likely to have babies that were born small for their gestational age compared to women without MS.
Overall, 3.4 per cent of women with MS had babies small for their gestational age, compared to 2.8 per cent of women without MS.
“We think the reason more women with MS have babies by elective c-section or induced delivery may have to do with MS-related symptoms such as muscle weakness, spasticity or fatigue that might affect the birth,” Professor Magyari says.
“Any of these could make a mother more tired and lead to delivery complications that could prompt the clinician and woman to take extra precautions.”
Researchers also found that mothers with MS were 13 per cent less likely to give birth to babies with signs of being deprived of oxygen, or asphyxia.
Professor Magyari said the higher prevalence of elective c-sections among women with MS most likely explains the corresponding lower odds of asphyxia.
A limitation of the study is the lack of data on the mothers’ smoking, which could cause babies to be born small for their gestational age.
Community neurorehab gym continues to expand
A community therapy centre which enables neuro patients access to the physio-led exercise which can support their recovery continues to expand in response to demand for its services.
West Berkshire Therapy Centre was opened in 2014 to bridge the gap in existing community resources, and initially opened for 20 hours a week with ten items of equipment.
Since that time, the Thatcham centre has expanded into premises twice the size of its initial home, and now has 17 items of equipment which clients can access 35 hours each week.
While the centre has been forced to close during lockdown periods, the investment in its offering has continued, with a further £17,500 being spent to upgrade equipment.
In addition to its regular clientele of around 260 people, around 200 more will be referred to the centre from the Berkshire Long COVID Integrated Service, led by Dr Deepak Ravindran, who has worked closely with the centre for several years.
As well as the anecdotal evidence from clients who attest the positive effect West Berkshire Therapy Centre has, the centre’s work has been proven to improve client mobility by an average of ten per cent, psychological outlook by 15 per cent and weight loss by three per cent.
All clients are assessed by the centre’s physio before being prescribed an individual exercise programme. The centre prides itself on its client-centred approach and some of the equipment in the gym has been designed and built specifically in response to what clients said were important to them.
West Berkshire Therapy Centre was created by the West Berkshire Neurological Alliance, a group of 23 local neuro charities, which recognised the need for greater specialist provision for people living with neurological conditions in the area.
John Holt was instrumental to the creation of both the Alliance and the Centre. Having supported his wife in living with MS for over 40 years, he took the lead on ensuring greater provision and support was there for those who needed it.
“I’m not from a medical background, I’m a food technologist, and while I was chair of a trade association during my career, I was used to working with competitors and business enemies, that was just what happened for the greater good of us all,” he says.
“So I was rather shocked when I got involved with the local voluntary sector and found that wasn’t the case. I was very proactive in all of our charities working together as I know the importance of working as one alliance.
“People who were living with neurological conditions were often having to fend for themselves when it came to community rehab, and that’s why we wanted to create the West Berkshire Therapy Centre.”
Having been established on the back of £145,000 in fundraising, five years later the demand for its services was such it had to expand into larger premises and invest in more equipment.
The centre – which is funded by voluntary contributions for sessions and through fundraising – now has eight part-time staff and a core of volunteers to support clients with whatever rehabilitation issues they have.
While most clients have neurological conditions – including stroke, Parkinson’s, MS and Post-Polio Syndrome – the centre has broadened its reach to include large numbers of people with arthritis, heart and lung conditions, sight impairments as well as amputees.
“We’re completely pan-disability and will support anyone who needs us. Our clients talk to us and we listen and adapt,” says John.
“I think many clients come to us because we are a safe place for them and they’re among people who understand the challenges they face.
“It is very important that we talk about things openly. For example, we talk about how hard it is when you can’t get to the bathroom in time and you wet yourself.
“When you face issues like that, it can be the start of a spiral downhill, you might then stop going to work or stop leaving the house, but we share these kinds of things.
“By having this interaction, it becomes a place people aren’t afraid to open up.”
With the centre having been closed for much of the past year, John and the team are ready to welcome back regular and new clients, including the many who are recovering from Long COVID.
“Many of our clients won’t have exercised for several months, but we hear very often that people have waited 20 years for a centre like this, so a few months hasn’t been long in comparison,” says John.
“But we are very much looking forward to re-opening and supporting our clients in regaining any progress and fitness they may have lost. Hopefully we are on the right track now after three lockdowns and clients can come back to us regularly.
“Long COVID is a new condition for us, as it has only come into being in the past few months, but we are ready to support people with their symptoms and in them using exercise as part of their recovery.”
Brain tech company secures funding to increase support post COVID-19
An online brain assessment platform has secured funding to enable its work in telehealth to continue to support people as the world emerges from the COVID-19 pandemic.
Cambridge Brain Sciences (CBS) is planning to expand its operation through a funding round from Canadian Shield Capital, a Toronto-based private equity investment firm, closely aligned to Hatch, a global engineering consultancy.
The investment will allow Candian-based CBS to further its work in digital health, especially around mental health, and respond to the need for accurate and reliable quantified measures of brain function and brain health – hailed as being essential to so many people who have suffered psychologically from the effects of COVID-19.
The funds will allow CBS to grow its sales and customer support teams rapidly, which will enable it to roll out its flagship product, CBS Health, further.
It will also enable it to expand on CBS Health features to help continue to refine and develop its cognitive care platform for healthcare professionals treating the growing mental health, brain injury and ageing patient populations.
The COVID-19 global pandemic has seen many healthcare practitioners to adopt platforms such as CBS Health to manage patients remotely.
As a result of lockdowns and ‘stay at home’ guidance, there has been exponential growth in patients seeking treatment for mental health conditions brought on, or exacerbated by, the pandemic, as well as individuals recovering from COVID-19 suffering with longer term neurological symptoms.
CBS Health has also grown as a result, and offers a web-based platform or integration which allows healthcare professionals to administer the CBS tasks standalone or alongside other established and validated complementary assessments (such as the PHQ-9, a standard scale for assessing the severity of depressive symptoms).
Assessments can be combined into a single session and administered in person or remotely via email—an option from which clinicians have benefitted greatly throughout the COVID-19 global pandemic.
The investment also contemplates further collaboration between CBS and Hatch, building upon an earlier successful pilot for a dedicated CBS platform to address corporate workplace mental health and safety at large scale industrial operations, construction sites and infrastructure projects.
“CBS is excited to be closing this round of financing which builds upon a long-term relationship with Canadian Shield and an earlier successful pilot with Hatch,” says Marc Lipton, president and CEO of Cambridge Brain Sciences.
“The funding will allow us to further accelerate the growth of our core CBS Health product especially amongst mental health practitioners, as well as to strategically explore, with Hatch, large corporate applications for workplace mental health and safety.”
“CBS brings many years of academic discipline and rigorous digital measurement of cognitive health, with applications in mental health, brain injury recovery, healthy ageing, and soon workplace safety,” says Andrew W. Dunn, managing partner at Canadian Shield Capital.
“The growing awareness of, and attention to, mental health conditions and CBS’ engaging and efficient approach gives it enormous runway.”
James Marzocca, global managing director for project delivery at Hatch, adds: “We see great potential to apply CBS testing as a non-invasive diagnostic to assess fitness for duty for individuals reporting to worksites where mental alertness is essential for their own safety and the safety of others.”
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