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Author: Louise Stanley

Birmingham launches pioneering trial to improve pregnancy outcomes for severe haemolytic disease

Written by Louise Stanley on . Posted in Clinical trials, Maternal health.

A pioneering study that took place at Birmingham Women’s Hospital has found an antibody that can improve the survival rate of unborn babies with rare, early-onset fetal anaemia, as a result of haemolytic disease of the fetus and newborn (EOS-HDFN).

Pregnant mothers have taken part in the UNITY trial, which has found that nipocalimab, an investigational, fully human, monoclonal antibody, has the potential to improve the survival rate of these babies.

BHP members the University of Birmingham (UoB) and Birmingham Women’s and Children’s NHS Foundation Trust (BWC) were a study site for a global, multicentre, open-label trial, in which nipocalimab was given for the treatment of pregnancies at high risk of severe EOS-HDFN, and evaluated safety, efficacy and the maternal metabolism of the monoclonal antibody.

Site investigator Mark Kilby, Emeritus Professor of Fetal Medicine at UoB and Honorary Consultant of Fetal Medicine at BWC said: “For mothers with severe HDFN the outcome not only of the condition but of the treatment, can be devastating. This is why the search for therapies to reduce the consequences of the maternal immune response has been focused on this cohort of women. The clinical study has found that nipocalimab is well tolerated and greatly increases the chance of unborn babies surviving severe EOS-HDFN, requiring less in-utero transfusion therapy.”

Haemolytic disease of the fetus newborn (HDFN), which is also sometimes referred to as Rhesus disease, is caused by a system of red blood cell antigens (most commonly of Rhesus D type) which raises the pathological antibody response in a pregnant person. These ‘pathological antibodies’ or alloantibodies can cross the placenta to the fetus and destroy its red cells, leading to progressive fetal anaemia and – if untreated – death of the fetus. 

Professor Kilby added: “These are fantastic results. In this group of pregnant women with severe HDFN, the medical management with nipocalimab has significantly reduced the need for early-onset in-utero fetal transfusion and improved the survival of these babies, reducing risks of miscarriage and stillbirth. Furthermore, and very importantly, nipocalimab seems to be well tolerated and safe for the mother and her unborn/newborn baby.   

“This research is a huge step forward for mothers who experience severe HDFN, as well as their partners, extended families, and of course, their children.”

Rosemary and Darren from Ireland were expecting baby Nessa when they took part in the clinical trial. Rosemary had had a previous in-utero transfusion for HDFN, and the couple had a child following treatment. Sadly, the couple lost a second baby after another in-utero transfusion. 

She was desperate to avoid another in-utero transfusion and was referred to the Fetal Medicine Centre at Birmingham Women’s Hospital eight weeks into her pregnancy after seeing news of the trial online and contacting her doctors at Dublin’s Rotunda Hospital. She had cell-free fetal DNA testing to confirm the baby was ‘suspectable’ to the antibodies she had produced. Rosemary then had maternal infusions of nipocalimab intravenously at weekly intervals from 14 to 35 weeks. 

Baby Nessa was born at 36 weeks weighing six pounds and 13 ounces and without the need for any IUTs.

Rosemary said: “When we were accepted onto the trial, we were both relieved and excited. Following the loss of our little girl Liliana, we were advised not to have any further pregnancies and we were devastated. This trial gave us hope of having another baby.”

“We were pregnant during the COVID lockdowns and as I was commuting from Ireland to Birmingham, it was a big worry but throughout our involvement in the trial, we felt supported, informed, understood and safe. We are forever grateful, the level of professionalism, compassion and empathy shown towards us is something we will never forget.” 

“Our two sons, Ollie and Joey now have a little sister, Nessa, who is a bubbly happy healthy four-year-old, full of mischief, giggles, and fun. To think the trial has given us what we believed was impossible, is a dream come true. To hear the trial has also given others living healthy children is fantastic. In a situation where we, like so many others felt was hopeless, to now know there is a treatment is like a miracle.”

New funding supports West Midlands healthcare and social work students into research

Written by Louise Stanley on . Posted in Birmingham Health Partners.

A collaboration between the NHS, social care and academic institutions across the West Midlands – including BHP’s Universities and NHS members – will inspire registered healthcare, social work and public health students to consider a range of research careers.

The National Institute of Health and Social Care Research (NIHR) has pledged £34.9m to encourage the regulated healthcare and social work professions into research roles as part of the new INSIGHT: Inspiring Students into Research scheme. This strategic move will accelerate the numbers of nurses, midwives, pharmacists, social workers and allied health professionals (AHPs) leading research and generating evidence to underpin care.

The West Midlands NIHR INSIGHT Consortium, led by BHP founding member the University of Birmingham, has been awarded £2.5m to provide fully funded research master’s courses to early career healthcare professionals and social workers. Working with local NHS trusts, students will be able to take the courses full or part time so they can continue their career pathways in healthcare. It is envisaged this initiative will provide the right start for the future research workforce and retain talent in the region.

For further information and to apply, visit the INSIGHT West Midlands Consortium page.

According to NIHR, the most recent headcount from 2017 showed that less than 0.1% of the nursing, midwifery and allied health professional workforce were involved with research. Yet it is well documented that research led by nurses, midwives, pharmacists, AHPs and other healthcare and social work professionals, and the contributions they can make as members of multidisciplinary research teams, can drive change to policy and patient care. Research is integral to high quality evidence-based care and has also been shown to increase job satisfaction for staff and improve retention, when conducted alongside delivering care.

The consortium sees seven universities and eight NHS trusts come together to accelerate the development and growth of future health and social work researchers. Suitable candidates will be allocated to higher education institutions and programmes according to discipline, personal and professional needs and student choice. The first cohort of places start from September 2024.

The programme will target those professions that don’t have much exposure to research during their professional training.

Professor Waljit Dhillo, Dean of the NIHR Academy, said: “We know how important early exposure to research is for building capacity within health and social care. The INSIGHT programme will offer over 300 funded research masters places per year and provide engagement activities that have the potential to excite and capture the imagination of students at an early stage in their career.

“I’m delighted that we can invest in our next generation of researchers in the West Midlands, and show students all of the benefits that research roles and careers have to offer.”

The West Midlands bid, put together with input from final year nursing students, patient ‘experts by experience’, early career clinical academics and research delivery staff from across our health and social care community, emphasised that research must reach out to all communities if it is to make a difference to the health and wellbeing of those living and working in the West Midlands. Collaborating institutions will seek to ensure that future practitioner researchers represent the communities they serve by ensuring access to funded postgraduate study.

Professor Liz Moores, deputy dean of Aston University College of Health and Life Sciences, said: “As a healthcare professional, having the knowledge and the ability to critically review others’ research and to meaningfully evaluate your own practice is a key part of improving healthcare for the future. This programme will help to support the workforce to develop those skills and Aston University is proud to be a partner in it.”

Dr Nikolaos Efstathiou, School of Nursing and Midwifery, University of Birmingham said: “We seek to provide a sustainable regional pipeline via which those motivated next generation researchers can acquire the skills and capabilities so they can have fulfilling careers delivering and leading research. With our many NHS, social care and research infrastructure partners we are fully committed to creating a positive place-based research and innovation environment for our talented graduates who aspire to be future clinical academics and research leaders.”

Professor Anne Topping, Professor of Nursing University Hospitals Birmingham NHS Foundation Trust and University of Birmingham said: “The programme is important for future-proofing our sustainable regional research workforce. Our programmes will produce those professionals, who are able to work collaboratively, generate, translate and implement best available science and evidence into real world interventions, ultimately bringing benefits to care, and the health and wellbeing of our communities.”

Led by the University of Birmingham, the programme is a partnership with (BHP members in bold): University of Keele, University of Warwick, Birmingham City University, Coventry University, Aston University, Staffordshire University, as well as Midlands Partnership NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Birmingham Community Healthcare NHS Foundation Trust, University Hospitals Birmingham NHS Foundation Trust, Birmingham Women’s and Children’s NHS Foundation Trust, Sandwell and West Birmingham Hospitals NHS Trust, University Hospitals of North Midlands NHS Trust and Birmingham and Solihull Mental Health NHS Foundation Trust and other health and social care providers across the region.

Fitness app could transform care of rheumatoid arthritis patients

Written by Louise Stanley on . Posted in Clinical trials, Inflammation and chronic disease.

Researchers at BHP members Sandwell and West Birmingham NHS Trust and the University of Birmingham aim to transform the care of rheumatoid arthritis (RA) patients by developing an app which links to the Fitbit – a popular activity tracker.

The rheumatology medical team and researchers are leading the groundbreaking clinical trial to create the app which they hope will ease the pain of patients suffering from the crippling disease and provide extra support.

It’s called MISSION-RA which stands for MovIng to Support Sustained Improvement of Outcomes iN Rheumatoid Arthritis.

Sally Fenton, Chief Investigator for the study, said: “The app will be specifically designed for and by people with RA.

“This will be done in two ways. Firstly, a series of interviews, co-design studies and workshops will be carried out to develop the app. Then, artificial intelligence will be used within the app to provide personalised support for people living with RA, based on symptoms such as pain, fatigue and mobility. It is expected the app will be available to download for free so it can be used on a Fitbit in the future.”

RA leads to inflammation of the joints and surrounding tissues which causes flare ups – this is when symptoms become worse. One of the ways to help ease these episodes of pain can be through exercise, physiotherapy and occupational therapy.

Dr Sangeetha Baskar, Clinical Specialty Lead for Rheumatology and Principal Investigator for MISSION-RA explained: “Rheumatoid arthritis is an extremely painful, tiring, psychological and physically debilitating disease. Patients face countless challenges while doing basic daily activities such as dressing, cooking and walking and often become dependent on family members to perform some of their daily tasks. Through this innovative study and the mobile app, we are hoping to help patients increase their physical activity tailored for them and improve their quality of life.”

The first patient from the Trust has already been recruited into the study.

Ana Duarte, Clinical Research Practitioner (CRP) and also Associate Principal Investigator, said: “Overall, the MISSION-RA study has overcome our initial expectations. Patients are very keen and have enjoyed their experience so far. This has also been a great opportunity for the study staff which has led to progression in their careers. Most importantly, this we hope will place SWB’s R&D department and rheumatology team as international leaders in healthcare AI and machine learning.”

MISSION-RA is being delivered in partnership with the National Institute for Health and Care Research (NIHR) and National Rheumatoid Arthritis Society (NRAS).

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Researchers at the Royal Orthopaedic Hospital and Aston University explore novel bone cancer therapy

Written by Louise Stanley on . Posted in Cancer outcomes, Experimental medicine.

Lucas Souza, Research Laboratory Manager for the Dubrowsky Regenerative Medicine Laboratory at the Royal Orthopaedic Hospital (pictured), is partnered with Professor Richard Martin, director of the Advanced Materials Research Centre at Aston University to explore a new way to treat bone cancer.

As bone cancer researchers, we are seeking to tackle the problem of bone tumours across all fronts. We are currently exploring how the metal element gallium could be used to support the treatment of bone tumours due to its cancer-killing properties.

Bone tumours can be either primary (originated in the bone tissue) or secondary (originated in another tissue and metastasise to bone tissue). We have already proved in a previous study that primary bone cancer cells are four times more sensitive to gallium than normal cells. In that study we wanted to understand if doping bioactive glasses, used in orthopaedic and dental surgeries for its bone forming properties, with gallium would support positive outcomes for bone cancer patients. We were able to show that the use of gallium embedded in bioactive glasses is an excellent strategy to support bone repair whilst selectively killing bone cancer cells which can potentially culminate with better treatment outcomes and reduced cancer recurrence rates.

The next phase of this study is exploring the use of gallium against bone metastases – cancer that originated in another tissue before spreading to bone. The ultimate goal is to prove whether cells from bone metastases also have greater sensitivity to gallium so it could be used as an adjuvant medicine to control metastatic growth in the treatment of other types of cancer that usually metastasise to bone, such as breast, lung, and prostate cancer.

If successful, we will combine the gallium-doped bioactive glass powder with biodegradable polymers to make a minimally invasive injective gel that surgeons can use to treat both primary and secondary bone tumours. This gel will have the potential to reduce cancer recurrence and implant failure rates, leading to reduced time in hospital beds, reduced use of antibiotics, fewer revision surgeries, and increased survival rates.

It is also hoped that this innovation could be used to improve outcomes for patients with vertebral metastases and other types of primary bone tumours where surgery and radiation is less effective due to their proximity to the spinal cord.

The safety and effectiveness of these biomaterials will need to be tested further, but the initial results are really promising. Treatments for a bone cancer diagnosis remain very limited and there’s still much we don’t understand. Research like this is vital to support in the development of new drugs and new methodologies for treatment options.

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Behind the scenes – meet the ROH research team

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Experimental medicine.

Written for BHP by Ellie Keeling, Lead Research Nurse at the Royal Orthopaedic Hospital

Birmingham is a major research hub with a thriving collaborative ecosystem convened by Birmingham Health Partners. Within this alliance, the Royal Orthopaedic Hospital (ROH) is leading the way in orthopaedic research, conducting clinical trials, observational studies, and laboratory research. Our work focuses on enhancing physiotherapy rehabilitation, developing therapies for bone tissue regeneration, and creating pharmaceutical treatments to reduce invasive surgeries and speed up recovery. ROH’s research aims to improve patient care, facilitate early diagnosis, support new drug development, and offer alternative treatments, consistently contributing new findings to the field.

The majority of this work happens behind the scenes. And the roles that make up this team are varied. They include our lab manager who oversees the management of the Dubrowsky Lab; research nurses; a research tissue bank co-ordinator; study co-ordinators; assistant clinical research practitioners; data managers; and a healthcare technician.

Research nurses play a vital role in delivering clinical research, guiding the patient as they go through the clinical research process and ultimately improving patient care and treatment pathways. It’s an incredibly diverse role, from recruiting patients for studies to collecting and tracking samples, and developing pathways to improve the delivery of trials. Because many clinical trials run over the course of several years, research nurses get to work with the same patients regularly and are able to build up a rapport with them.

Our research tissue bank co-ordinator manages our research tissue bank, which was established over thirty years ago and contains the world’s largest archive of frozen bone tumour samples – currently numbering 32,000 – including all orthopaedic malignancies as well as other benign and non-tumour tissue types. The research tissue bank is used by researchers across the globe who need access to bone and tissue samples that they can’t get elsewhere, with the samples supporting clinical projects to better understand cancers like chondrosarcomas (cancer of the cartilage cells) or develop new treatments for primary bone cancer.

The team is involved in a number of clinical trials, including the BASIS study and the RACER Hip and Knee studies. We are one of the main recruiting centres for the BASIS study, which is trying to find out which type of back brace is best for treating children and young people with scoliosis. The RACER Hip and Knee studies are exploring clinical effectiveness of robotic assisted hip and knee replacement. Pivotal to the success of these studies is patient recruitment – working closely with patients and recruiting them onto these clinical trials with empathy. Our assistant clinical research practitioners (ACRPs) are critical here, as this research couldn’t happen without the generosity of patient donations and their time. In this role, ACRPs work closely with patients to explain what research we are doing, explore how the patient could potentially participate in this research and support them through the process.

It’s essential that patient donations are viable and there are several steps required to ensure this. The role of the healthcare technician is a rare role, but a key one at ROH as it enables a clear and consistent pathway for the effective collection and packaging of patient bone and tissue samples.

Finally, our data managers keep all this work running smoothly by supporting the team with the collection and storing of patient data. This support helps our researchers identify what patient data could support new and existing clinical research as well as retrospective data-led research, all the while ensuring compliance and confidentiality.

While many research roles, especially in hospitals, are perceived as being behind the scenes, they are incredibly important bringing unique skills and knowledge and their contribution is crucial in making breakthroughs that can improve lives.

For more information on The Royal Orthopaedic Hospital’s research activities, visit Royal Orthopaedic Hospital – Research (roh.nhs.uk).

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Patients with recent onset diabetes fast-tracked more effectively for pancreatic cancer screening

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection, Inflammation and chronic disease.

A recent study, funded by Pancreatic Cancer UK and conducted by researchers at BHP’s University of Birmingham, in collaboration with University of Oxford, University of Nottingham and fellow BHP founder-members University Hospitals Birmingham NHS Foundation Trust, developed a new prediction model as an effective way of identifying individuals suitable for fast-track abdominal imaging.

Weight loss and glycaemic control are known biomarkers that can indicate pancreatic cancer risk and in, accordance with NICE recommendations, people over the age of 60 years with recent onset diabetes and weight loss currently undergo urgent abdominal CT imaging to assess for pancreatic cancer.

Pancreatic cancer is known for its poor prognosis, with less than a quarter of patients surviving past one year after diagnosis. Early detection is important as patients with early-stage disease are more likely to be able to tolerate chemotherapy and therefore have an improved 5-year survival rate, but most patients are not diagnosed until the later stages of the disease. One way of detecting pancreatic cancer patients sooner is through screening patients with diabetes as there is a known association.

By looking at further potential biomarkers to determine which patients would benefit from referral for abdominal imaging, there is a chance of picking more cancers and reducing the cost of imaging those who are not so high-risk.

Dr Shivan Sivakumar, Associate Professor in oncology, specialising in pancreatic, liver and biliary tract cancer, said: “One in ten pancreatic cancer patients have new-onset diabetes and we know that some patients with newly diagnosed diabetes are worth exploring further to improve early detection of pancreatic cancer. We need to more accurately predict which of those patients should be referred for further investigation. We used health data records, from a larger patient population than has previously been studied, to develop a more nuanced method of stratification that could improve referral pathways.”

This study used large-scale, population-representative, linked electronic health data records to develop and evaluate a new prediction model that can be used to predict risk of developing pancreatic cancer within two years of a diabetes diagnosis. The new models used a variety of potential markers and were able to predict pancreatic cancer risk in patients aged between 30 and 85 years, rather than relying on the 60+ rule of thumb.

This study was the largest of its kind and offers improved accuracy compared to previous prediction models as it used a larger data set. The new prediction model could be more effective than current ‘rules-based’ referral guidelines. Further external validation and health economic assessment is recommended.

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