Month: August 2023

Stem cell therapy for heart attack patients trialled at UHB

Written by Louise Stanley on 23/08/2023. Posted in Clinical trials, Experimental medicine.

A stem cell therapy trial at BHP founder-member University Hospitals Birmingham is having a life-changing effect on heart attack patients, with scans showing almost complete restoration of heart muscle function just weeks after the procedure.

After a heart attack, around 30% of patients are left with severely damaged and weakened hearts which can, over time, lead to life-threatening heart failure, as the heart is unable to pump the blood around the body properly. The trial therapy aims to prevent this heart failure by regenerating the damaged muscle.

Developed by biotechnology company CellProthera, the therapy involves the application of a person’s own stem cells directly into their heart, through the femoral artery in the leg. The patient’s heart activity is then monitored for six months – at 1, 3 and 6 months – using echocardiography and magnetic resonance imaging (MRI).

66 year old Kim Smith is one of four patients recruited to the trial at UHB and was randomly allocated to the experimental arm of the study, meaning that she received the therapy as treatment following her heart attack. Just two weeks after receiving the therapy, Kim’s heart function had returned to almost normal (55%).

Kim said: “I now feel as though I can actually do what I used to do before. When I had the heart attack, I was worried that I was going to end up being stuck at home all day, but since having the stem cell therapy, psychologically and physically, I just feel so much better.

“I’m so grateful to have had this treatment, and I do hope that the research that they are doing goes forward because I think a lot of people would benefit. That was my reason for doing it in the first place – even if it does nothing for me, it could help someone else.”

So far, approximately 50 patients from the UK and France have been recruited to the trial, known as the EXCELLENT (Expanded Cell Endocardial Transplantation) study. The research is currently in its final phase, with results expected later this year.

Dr Sohail Khan, Consultant Interventional Cardiologist and Lead Investigator at UHB for the EXCELLENT study, said: “What we have seen so far is that actually the stem cells do seem to have a dramatic effect in terms of improving heart muscle function.

“Currently, there are few clinical options available that repair and regenerate heart tissue following a heart attack. As a result, the only option for many patients that have suffered a heart attack and developed advanced heart failure, is a fully invasive heart transplant. This is a very serious procedure for the patient, and very costly for society.

“The development of a cell therapy to regenerate cardiac tissue will be transformative for a considerable number of patients globally. A minimally invasive, cell therapy, that uses a patient’s own stem cells, could also considerably reduce treatment costs.”

Matthieu de Kalbermatten, CEO at CellProthera, said: “Bringing the therapy to market as a minimally invasive therapy is vital to tackle, from the root, the harmful effects of heart attacks and improve quality of so many lives.

“The impressive progress of the CellProthera EXCELLENT trial is a testament to the work of our team and our stakeholders. All of the trial sites in the UK and France are committed to admitting and treating the final patients as quickly as possible. In 2024, we will look to start the phase III trial, where we will be recruiting patients from across Europe, with the aim of potential future market authorisation and bringing this vital treatment to all patients.”

NIHR awards £4m to Birmingham Clinical Research Facility to enhance the delivery of research

Written by Louise Stanley on 21/08/2023. Posted in Birmingham Health Partners, Clinical trials, Experimental medicine.

The Birmingham NIHR Clinical Research Facility (CRF) has been awarded £4 million from the National Institute for Health and Care Research (NIHR).

This funding is part of a total investment of £96 million that has been awarded to NHS organisations across England, to enhance the delivery of research through improving research facilities for patients across the NHS, helping teams to find new ways to prevent and treat diseases.

The Birmingham NIHR CRF is a collaboration between three BHP members – University Hospitals Birmingham NHS Foundation Trust (UHB), Birmingham Women’s and Children’s NHS Foundation Trust (BWC) and the University of Birmingham (UoB).

In Birmingham, new equipment will enable the delivery of innovative health technology services, including a range of cell and gene therapies requiring specialist pharmacy facilities. For example, onsite isolators will support preparation within the research facilities, speeding up the delivery of CAR-T trials for patients with haematology (blood) cancers, as well as trials into cancer vaccines for patients with a variety of solid tumour cancers.

The funding will also provide new laboratory equipment, essential for storing samples from patients recruited to metabolic research studies. This will support researchers with ground breaking work in the prevention, treatment and management of metabolic disease for adults and children across Birmingham.

The bid was led by Jo Gray, NIHR Birmingham Clinical Research Facility Clinical Manager, who said: “This successful bid for equipment and upgrades to our facility is fantastic and will make such a difference to patients and research teams across all partner sites.

“We have ambitious plans in place to upgrade existing equipment, as well as increase our ability to support new research across the sites. New equipment will include a paediatric ‘peapod’, which measures body composition and growth in premature born infants, and biosafety cabinets, which provide an enclosed ventilated space for drug preparation.

“Our portfolio of gastrointestinal (GI) and respiratory studies will also be able to grow with the addition of new endoscopy equipment. One of the key GI trials to benefit will be the INCEPTION clinic for patients with Inflammatory Bowel Disease (IBD). This trial aims to improve diagnosis and prognosis, and make more informed decisions on IBD treatment through biomarker discovery and implementation, by understanding more about how different microbiomes affect gut and oral immune responses.”

Professor Lorraine Harper, NIHR Birmingham Clinical Research Facility Programme Director, added: “We are tremendously proud that our hospitals have been selected for this award from the NIHR to improve the delivery of research in our local population. The award, which builds on existing clinical-academic collaborations facilitated by Birmingham Health Partners, will benefit our adult and paediatric patients, improving their access to new therapies and treatments, which can potentially be life-changing.”

Dr. Jan Idkowiak, NIHR Birmingham Clinical Research Facility Director (BWC), said: “This is very exciting. This award allows us to expand our ability to deliver cutting-edge clinical research beyond the Children’s Hospital, as it will enable us to include pregnant women and their children at the Women’s Hospital. This will be a huge benefit for our patients and will offer great opportunities to develop new therapies.”

Professor Philip Newsome, Director of the NIHR Birmingham Biomedical Research Centre (BRC), commented: “This is fantastic news for both the CRF and for the organisations that work with them, like the Birmingham BRC. The CRF has been a key partner in delivering many of our experimental research studies, and we collaborate closely on our training, patient and public involvement, and equality, diversity and inclusion programmes too. We are looking forward to continuing working together to deliver patient benefit.”