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Author: Louise Stanley

Birmingham Health Partners announces theme leads to drive strategy

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

The second city’s clinical-academic alliance, Birmingham Health Partners, has appointed three strategic theme leads to support the implementation of its new five-year mission: to work together, transforming Birmingham’s healthcare through high impact innovation.

Taking the new role of Health Inequalities Lead, Dr Joht Singh Chandan is a Clinical Associate Professor in Public Health at the University of Birmingham where his research focuses on identifying and addressing health inequalities – with a particular interest in abuse and violence prevention inspired by many years of working as a voluntary police officer.

As the UK’s third-poorest city, with a diverse ethnic profile and socioeconomic demographics, Birmingham experiences significant health disparities. Joht will develop a detailed action plan for improving population health in the city, underpinned by his experience of issues that impact widely on health and wellbeing; factors that prevent early detection; and barriers to accessing healthcare.

Joht said: “We shouldn’t see reducing health inequality as just the responsibility of public health bodies. The determinants of inequality are so interlinked that not only can we not tackle issues in isolation, we can’t tackle them as one institution. Working across the partnership and linking health data platforms, we’ll be able to work in a much more representative and inclusive way to improve physical and mental health outcomes for our local communities.”

Tasked with optimising data integration across the partnership, Professor Simon Ball has been appointed Academic Lead for Data. A Consultant Nephrologist, Simon has had various roles in developing electronic health care records and using data to improve patient care and support research. His other roles currently include Associate Director for the Midlands Health Data Research UK and Senior Responsible Officer for the West Midlands Secure Data Environment (WMSDE).

Simon said: “NHS Trusts in Birmingham were among the first to adopt electronic health records systems, meaning we have access to a wealth of data – including blood tests, scans and biopsies – spanning several decades. This can provide valuable insight into an array of diseases, health conditions and care pathways – but only if it is integrated. Working together, BHP and the WMSDE can ensure our data is analysed, learnt from and used to optimise healthcare across our region.”

Leading the ‘Reducing Bureaucracy in Clinical Trials’ programme is Amy Smith, an experienced Senior Programme Lead with considerable experience in clinical trials across multiple BHP NHS Trusts and NIHR infrastructure. The programme responds to the challenges identified by Professor Adam Tickell and Lord O’Shaughnessy, ensuring patients in Birmingham get access to clinical trials more quickly. 

Amy said: “I am very proud to be leading this exciting project which showcases BHP as a leader in clinical trials.  Through trust, transparency, and collaboration we will harness the extensive knowledge and expertise within BHP, delivering improved setup times. Ultimately our aim is to make trials accessible to a diverse range of patients, quicker – increasing our attractiveness to funders and industry partners.”

New stromal cell treatment trial for chronic inflammatory diseases

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

People with chronic inflammatory diseases are taking part in a new cell therapy clinical trial that one participant said made them feel “miles better”.

The POLARISE trial, being organised by BHP founder-member the University of Birmingham and funded by a grant from Innovate UK is testing a type of cell therapy – stromal cells – to see whether they can resolve symptoms and inflammation in patients with certain autoimmune diseases including rheumatoid arthritis and primary sclerosing cholangitis.

A Phase 2 trial, POLARISE will investigate the safety and activity of ORBCEL – a stromal cell therapy that has been developed by Orbsen Therapeutics Ltd. Stromal cells are rare cells found naturally in the human body where they stimulate resolution of injury and inflammation via a natural healing process called efferocytosis. Stromal cells are also allogeneic – which means they can be purified from one donor and given to multiple patients without causing allergic reactions – so there is no need for donor matching.

These rare stromal cells are ethically sourced and purified from human donor tissue and expanded to therapeutic doses at the University of Birmingham’s Medicines Manufacturing Facility (MMF).

The ORBCEL therapy is administered intravenously across two visits with subsequent hospital appointments to check on the progress of their condition during a two-year trial period.

Philip Newsome, Professor of Hepatology and Honorary Consultant Hepatologist at the University of Birmingham is leading the POLARISE trial, and explained: “Stromal cells are an exciting potential treatment for inflammatory diseases. These diseases are debilitating and very hard to treat as the body has switched a natural defence system for dealing with threats to one that starts attacking itself. It’s therefore critical to find ways to support the body to naturally deal with inflammation rather than turn off the defences which can lead to all sorts of infections. Early results from previous trials using Orbsen’s ORBCEL stromal cell therapy are encouraging and we’re hopeful that the treatment will be beneficial for some patients.”

Stromal cells such as Orbsen’s ORBCEL therapy can be purified from bone marrow or umbilical cord tissues donated by healthy individuals with donor consent under ethical approval by the Anthony Nolan Trust. While each single bone marrow or umbilical cord contains only few thousand stromal cells – these cells can be purified by Orbsen’s technology to undergo controlled expansion in cleanroom bio-reactors to produce a thousand allogenic doses of ORBCEL from each tissue.

Within the Innovate UK-funded Advanced Therapies Treatment Centre (ATTC) Consortium and POLARISE trial – these tissues are transported from the Anthony Nolan centres to the Advanced Therapies Facility (ATF) at the University of Birmingham – where Orbsen and ATF staff collaborated to purify and manufacture doses of Orbsen’s Stromal cell therapy – ORBCEL- using patented technologies and Terumo’s Quantum Cell Expansion Bioreactors.

Orbsen Therapeutics Chief Scientific Officer, Steve Elliman said: “We are delighted to continue our significant and productive clinical collaborations with Prof. Newsome, the University of Birmingham – and the Anthony Nolan Trust – to determine the safety and efficacy of our ORBCEL therapies in patients with chronic inflammatory diseases.

“These First in Human (FIH) trials are difficult to undertake and deliver – even more so during the COVID19 pandemic. These trials are not possible without brave patients – like Hannah Dines – who volunteer to participate in these rigorous safety trials. And so, we take this opportunity to thank the patients, nurses and clinical teams who work so hard to complete these invaluable studies.

“We look forward to completing these important safety trials and look forward to examine how ORBCEL can encourage resolution of symptoms in patients with chronic inflammatory disease.”

The Innovate UK-funded POLARISE trial represent the third major clinical trial collaboration between The University of Birmingham and Orbsen Therapeutics to assess the safety and efficacy of Orbsen’s ORBCEL therapy. Professor Phil Newsome is also leading the EU FP7 funded MERLIN clinical trial that is assessing ORBCEL as a therapy for patients with autoimmune liver diseases. The MERLIN trial is complete and is expected to report in the first half of 2024.

Orbsen is also collaborating with Prof Paul Cockwell at the University of Birmingham and Professor Giuseppe Remuzzi at the Mario Negri to assess the safety of ORBCEL as a therapy for Chronic Kidney Disease caused by Type 2 diabetes, in a Phase 1/2 clinical trial called NEPHSTROM. Professors Cockwell and Remuzzi recently published the first results from NEPHSTROM in the prestigious Journal of the American Society of Nephrology (JASN). In the NEPHSTROM trial publication in JASN, a low dose of ORBCEL was reported to be safe and promote stabilization of kidney function over 18 months in patients suffering with Progressive Chronic Kidney Disease and type 2 diabetes.

Patient story – Hannah Dines, Rio 2016 Paralympian

Self-confessed ‘type A person’, Hannah Dines is one for setting mad goals. Born with cerebral palsy, freelance writer and sportswoman Hannah trained and raced for Great Britain in para-cycling including racing at the Rio 2016 Paralympic games, and now represents GB in adaptive surfing.

However, in 2021 during the buildup to the delayed Tokyo games Hannah was diagnosed with a chronic inflammatory disease called Primary Sclerosing Cholangitis (PSC) in which the bile ducts in the liver get progressively narrower can lead to liver failure and impacts other organs like the spleen, intestines and bowel.

Hannah explains: “I was diagnosed with PSC after struggling with major fatigue and worsening of my spasticity from my cerebral palsy. I would train and feel very ill but do it anyway. I love moving my body and during the training I still felt that joy. Still, I began to fear the symptoms that would come after. I used to call it having an ‘exercise hangover’ though I rarely drank alcohol and was in my twenties. I would ensure I had at least four hours after training to collapse in bed, too tired to even watch TV, feeling too ill to sleep, known as malaise.”

“By the point of diagnosis though I was really ill and sleepy every day, I couldn’t focus but I kept pushing with my training, a part time job and then bed. Finally, a clinical doctor took my blood to put me on an alternative spasticity medication that required a liver function test. That’s when I was sent to a liver clinic and they took a liver biopsy right away and found out my sclerosis was pretty serious.

“It made all my symptoms make sense and because I was young and sporty no-one misdiagnosed me with fatty liver or alcoholism, which was nice, even if it didn’t really lessen the impact of having PSC.”

After receiving her diagnosis, qualified physiologist Hannah knew she wanted to try and take part in a clinical trial although received a series of rejections due to the advanced nature of her PSC.

Hannah continues: “I was recommended for POLARISE and I didn’t hesitate. The day after my first dose I felt incredible and not just because the clinicians administering the drugs were so nice. This effect lasted a couple of days and I truly felt released from PSC.”

“I was still competing at a sport: adaptive surfing and I booked all my contests because I knew I wouldn’t need to cancel. I laughed out loud on an aeroplane because I felt real energy for the first time in years. It was probably the steroids or a placebo effect but my liver function tests also got much better.

“My second dose was a little underwhelming compared to my first, but I still felt miles better. My “malaise” and feeling kind of “dead” had gone away.

“I used to obsess over my blood values and stopped checking them. I started setting goals more than two months in advance, which I had decided not to do after a year of having to cancel everything. We’re now six months and I still big hits of malaise but just to know that respite might be possible like at the start of my trial…that’s really special..

“All I can do is hope the findings are positive and this can become a regular treatment for people with PSC. No matter the result of POLARISE it has given me real hope for the future.”

Not letting PSC stop her, Hannah has taken up adaptive surfing and last year represented GB at the world championships, finishing fourth in her category and supporting Team GB to their most successful championships yet.

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Treatment hope for patients with rare disorder following clinical trial

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

Patients with a rare hereditary disorder may soon benefit from a new treatment which has undergone a promising trial at Queen Elizabeth Hospital Birmingham (QEHB) – part of BHP founder-members University Hospitals Birmingham NHS Foundation Trust.

The experimental drug, called mRNA-3927, has been tested on patients for the first time as part of a study into propionic acidaemia – a serious metabolic disorder which means the body is unable to process certain parts of proteins and fats properly. This can lead to a build-up of harmful substances in the body and, without appropriate treatment, can be fatal.

Patients with this condition must follow a specific diet, including a low protein intake and specific food for life. Symptoms include: vomiting, lethargy, dehydration, and acid build up in the body. Liver and kidney transplant is a surgical option that can help reduce the frequency of acute metabolic episodes.

QEHB is the only adult centre in the world running this study whose initial findings have just been published.

Prof. Tarekegn Hiwot, Consultant in Inherited Metabolic Disorders at QEHB and Honorary Professor in the Institute of Metabolism and Systems Research at fellow BHP founder the University of Birmingham, led the trial and recruited patients for the study. He said: “We conducted a study of mRNA-3927 with 16 participants to find the safety, tolerability, and optimal dose. Our interim analysis has shown significant reduction of 70% in preventing severe metabolic crisis. The treatment was safe and well tolerated.

“In summary, this study explores a promising, first of its kind treatment for propionic acidaemia using mRNA-3927, aiming to improve patients’ health and reduce dangerous metabolic events.

“This study may also serve as a proof of concept in using mRNA treatment for other life limiting single gene genetic conditions in general.”

The interim results of the study were published in Nature.

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Center of Excellence Award Renewal for Allergy, Asthma and Immunology Center

Written by Louise Stanley on . Posted in Birmingham Health Partners, Inflammation and chronic disease.

The Allergy, Asthma, and Clinical Immunology Center in Birmingham has been successful in renewing its Center of Excellence status for another four-year term – re-affirming the Center’s international recognition for multidisciplinary scientific and clinical innovation – following a successful bid led by Professor Mamidipudi Thirumala Krishna, representing Birmingham Health Partners.

Renowned for its innovative services to accelerate education and research, the Institute of Immunology and Immunotherapy, and the School of Pharmacy at the University of Birmingham in collaboration with the West Midlands Allergy and Immunology service at University Hospitals Birmingham (UHB) NHS Foundation Trust has once again been designated as a World Allergy Organisation (WAO) Center of Excellence.

There are currently 82 Centers worldwide, and only three other similar Centers of Excellence in the UK.

According to the World Allergy Organisation (WAO), their Centers of Excellence accelerate multidisciplinary science and clinical innovation, training, and advocacy worldwide to deliver world-class education, research, and training to stakeholders in asthma, allergy, and clinical immunology.

Professor Mamidipudi Thirumala Krishna said: “This continued recognition of our Center of Excellence signifies our commitment to delivering world-class clinical services, fostering excellence in education and research, and nurturing collaborative relationships both nationally and internationally and contributing to global health.”

Professor Ben Willcox, Director of the Institute of Immunology and Immunotherapy at the University of Birmingham, commented: “We are proud to see our Center of Excellence renewed, guided by the visionary leadership of Professor Krishna. We have over 50 years of experience in world-leading immunology research, and this Center’s status renewal is testament to that.”

Professor Anthony Cox, Head of the School of Pharmacy and Professor in Clinical Pharmacy and Drug Safety, said: “Great news that the World Allergy Organisation Center of Excellence has been extended. The School of Pharmacy is proud to be working with the center on issues related to allergy and medicines – including inappropriately identified drug allergies which have a considerable impact on patient safety and the rational use of medicines.”

Dr Richard Baretto, Clinical Service Lead for the Department of Allergy and Immunology at UHB, added: “This prestigious award from the World Allergy Organisation is testament to the efforts of all the members of the clinical teams, providing excellent care for our patients with allergic disease. It emboldens us all to strive for continued improvement in our service through regular review, research and innovation.”

Professor Adel Mansur, Lead for Birmingham Regional Severe Asthma Service, commented: “On behalf of the Birmingham Regional Severe Asthma Service I am delighted of the news of extending our status as World Allergy Organisation Center of Excellence, recognising the excellent work done in Birmingham. Over the last three years tremendous work and development have been achieved to further strengthen our Center in areas of research, education and training and to lead on clinical excellence in allergy, asthma and clinical immunology.”

“We have adopted various initiatives to improve our patients outcomes, access and equity of service delivery and provide conducive environment for our trainees to learn and develop skills and further their career.  Our national and international contribution to research and education in these fields are also important developments and targets to progress further over the next 4 years which I look forward to with excitement.”

Dr Gareth Walters, NHS consultant in occupational respiratory medicine and interstitial lung diseases in Birmingham, also added: “On behalf of the Birmingham Regional NHS Occupational Lung Disease Service , we are very pleased that our status as a World Allergy Organization Center of Excellence has been renewed for a further 4 years. This is testament to the hard work and dedication of our multi-disciplinary team, who go above and beyond to diagnose and manage a range of occupational lung diseases.”

The Allergy, Asthma and Immunology Center will continue to lead global healthcare innovation and pursue its commitment to excellence in research and education for another term commencing in 2024 to 2028. 

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£12m research centre will improve efficiency of rare disease trials to unlock tests and treatments

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

Researchers from BHP founder member the University of Birmingham are part of a new £12m research centre to improve clinical trials for rare diseases.

The LifeArc Centre for Acceleration of Rare Disease Trials brings together a consortium of three universities from across the UK. Newcastle University, Queen’s University Belfast, and University of Birmingham are pooling their expertise in a partnership coordinated by Professor David Jones, Professor of Liver Immunology at Newcastle University.

The £12m centre will focus on improving the efficiency of rare disease trials and increasing the number of opportunities for patients to take part, through a new UK ‘4 nations’ approach to deliver trials of new treatments using ‘one stop’, patient friendly models.

The team will do this by creating a rare disease trial recruitment portal and will design and deliver trials in partnership with patients. This will speed up the delivery of clinical trials for people with rare diseases and enable more rapid approval of new therapies for use in the NHS.

Professor Timothy Barrett, Director of the Centre for Rare Disease Studies at the University of Birmingham commented: “Birmingham is justly proud of its hospital services and scientific research for people living with rare conditions, which build on our partnership between hospitals and University and reflects the cosmopolitan nature of our region. 

“This award will represent a stepping stone in our ambition for patients in Birmingham to get more treatments to more people with rare diseases, faster. It also allows us to expand capacity for rare disease clinical trials for the whole of the UK.”

Kerry Leeson-Beevers is the parent of a child with the rare genetic condition, Alström Syndrome, which often causes loss of vision and hearing, and can lead to serious life-threatening problems with the heart, liver and kidneys.

Kerry, who is also CEO of Alström Syndrome UK, explained: “We have no specific treatment for Alström Syndrome and when my son, Kion, was a baby, I was told it could take around 10 years for any treatment to be developed. 20 years later, we are still waiting. People living with rare conditions don’t have the luxury of time and the mainstream way of delivering healthcare and drug development rarely works for people with rare conditions.

“As a mum and the Chief Executive of Alström Syndrome UK, having a centre that will deliver a coordinated, inclusive and supportive approach to accelerate clinical trials gives me great hope.”

The LifeArc Centre for Acceleration of Rare Disease Trials, along with the the LifeArc Centre for Rare Respiratory Diseases, LifeArc Centre for Rare Kidney Diseases, and LifeArc Centre for Rare Mitochondrial Diseases, has been awarded a share of nearly £40M over five years from the not-for-profit medical research charity, LifeArc.

Each centre will tackle an area of unmet need, to unlock science, accelerate medical progress and have the greatest impact for patients.

Dr Catriona Crombie, Head of Rare Disease at LifeArc, said: “We’re extremely proud to be launching four new LifeArc Translational Centres for Rare Diseases. Each centre has been awarded funding because it holds real promise for delivering change for people living with rare diseases. These centres also have the potential to create a blueprint for accelerating improvements across other disease areas, including common diseases.”

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Midlands-Wales Advanced Therapy Treatment Centre part of £17.9m network renewal

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

The Advanced Therapy Treatment Centre network includes the Midlands-Wales Advanced Therapy Treatment Centre, jointly delivered by BHP founding members the University of Birmingham and University Hospitals Birmingham.

The National Institute for Health and Care Research (NIHR), Innovate UK, the Advanced Therapy Treatment Centre Network and the Cell and Gene Therapy Catapult (CGT Catapult) have announced a £17.9 million strategic initiative to keep the UK as a location of choice for advanced therapy research and advanced therapy medicinal product (ATMP) clinical trials.

The initiative will provide a further four years of funding for the Advanced Therapy Treatment Centre Network (ATTC Network) which is currently composed of three centres: Innovate Manchester Advanced Therapy Centre Hub; Midlands-Wales Advanced Therapy Treatment Centre; and the Northern Alliance Advanced Therapies Treatment Centre.

The Midlands-Wales centre has multiple sites across England and Wales, with the Birmingham hub being jointly delivered by BHP founding members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, directed by Professor Philip Newsome from the University’s Institute of Immunology and Immunotherapy. Its aim has been to enable UK advanced therapy companies to reach the clinical market, whilst simultaneously building clinical capacity and capability regionally to deliver these breakthrough therapies to patients. It brings together a wide range of specialists in advanced therapy manufacturing including academic and commercial partners, logistics companies, specialists in clinical trial delivery and teams focussed on IT solutions and health economics.

Professor Philip Newsome, Director of the Midlands and Wales Advanced Therapy Treatment Centre and national clinical lead, commented: “This funding will accelerate the delivery of advanced therapy trials across the Midlands, Wales and beyond. It is an exciting time for patients, researchers and industry as new therapies are trialled and enter routine clinical care.”

The UK is a world leader in ATMP clinical research with 175 ongoing trials being carried out here, and with 9% of global ATMP trials having representation in the UK. Many more products are in development and further action is needed to ensure that the NHS is able to bring advanced therapies to patients at scale across the UK.

Through this further funding, and in close collaboration with NIHR infrastructure and the devolved equivalents, the ATTC network aims to build on its work on advanced therapy clinical trial readiness to ensure the UK maintains its position as a globally attractive location for clinical research.

Health Minister Andrew Stephenson said: “This investment reaffirms the UK’s position as a global leader in clinical research. It will help roll out revolutionary medical products more quickly, potentially treating the root cause of disorders and diseases like Alzheimer’s and cancer. Harnessing technological and digital innovations is one of our primary focuses under the first ever NHS Long Term Workforce Plan, enabling new and advanced ways of working.”

Dr Stella Peace, Executive Director for the Healthy Living and Agriculture Domain at Innovate UK, said: “From our initial investment to now overseeing the delivery of the new four-year programme, our goal is to ensure the UK maintains its global leadership in clinical research. Our commitment to fostering innovation and scientific advancements is crucial for sustaining this leadership. This drives medical breakthroughs, as well as strengthening the UK economy by attracting investments, generating high-skilled jobs, and positioning us at the forefront of transformative healthcare discoveries.”

Professor Marian Knight, Scientific Director for NIHR Infrastructure, commented: “The NIHR is committed to ensuring that the UK provides a research environment to enable rapid assessment of new advanced therapies with the potential to transform health and care. Partnerships such as these, linked with existing NIHR research infrastructure, will help ensure that the UK public is able to benefit from these ground-breaking new treatments.”

Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, added: “Advanced therapies have the potential to transform healthcare, providing a range of new, lifechanging treatments to patients. Thanks to far-sighted investments, like this commitment by NIHR and the on-going support of Innovate UK, the UK is recognised globally as a pioneer in advanced therapies. With the continued great work of the ATTC network, we hope to further build the reputation of the UK.”

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