Overview of the Study
A new study, led by Queen Mary University of London and Barts Health NHS Trust, is exploring the potential of stem cell transplants to ease Crohn’s disease symptoms. The research is funded with £2 million from a partnership between the Medical Research Council (MRC) and the National Institute for Health Research (NIHR). The trial is coordinated through the Clinical Trials Unit at the University of Sheffield and will recruit patients from multiple centers across the UK, including Cambridge, Edinburgh, Liverpool, London, Nottingham, Oxford, and Sheffield.
What is Crohn’s Disease?
Crohn’s disease is a chronic inflammatory condition affecting the lining of the digestive system. It causes:
- Diarrhea
- Abdominal pain
- Extreme fatigue
- Other symptoms that significantly impact quality of life
Current treatment options include anti-inflammatory drugs, which show varying levels of effectiveness. In severe cases, surgery is needed to remove the diseased part of the bowel. After multiple operations, some patients require a stoma, where the bowel is diverted to an opening in the stomach, and waste is collected in a pouch.
The Need for Alternative Treatments
Professor James Lindsay, the study’s chief investigator, from Queen Mary’s Blizard Institute and Barts Health NHS Trust, explained:
“Despite the introduction of new drugs, there are still many patients who don’t respond, or gradually lose response, to all available treatments. Although surgery with the formation of a stoma may be an option that allows patients to return to normal daily activities, it is not suitable for some, and others may not want to consider this approach.”
He continued:
“We’re hoping that by completely resetting the patient’s immune system through a stem cell transplant, we might be able to radically alter the course of the disease. While it may not be a cure, it may allow some patients to finally respond to drugs which previously did not work.”
Patient Perspective: The Impact of Stem Cell Therapy
Helen Bartlett, a Crohn’s disease patient who underwent stem cell therapy at John Radcliffe Hospital, Oxford, shared her experience:
“Living with Crohn’s is a daily struggle. You go to the toilet so often, you bleed a lot, and it’s incredibly tiring. You also always need to be careful about where you go. I’ve had to get off trains before because there’s been no toilet, and I needed to go there and then.”
“I’ve been in and out of hospital for the last twenty years, operation after operation, drug after drug, to try to beat this disease. It’s frustrating, it’s depressing, and you just feel so low.”
“When offered the stem cell transplant, it was a complete no-brainer as I didn’t want to go through yet more failed operations. I cannot describe how much better I feel since the treatment. I still have problems, and I’m always going to have problems, but I’m not in that constant pain.”
How Stem Cell Transplants Work
Stem cell transplants have recently shown success in treating multiple sclerosis (MS). This trial will investigate whether a similar approach can:
- Reduce gut inflammation
- Improve drug response for Crohn’s disease patients
The treatment process involves:
- Chemotherapy and hormone treatment to mobilize stem cells.
- Harvesting the stem cells from the patient’s blood.
- Further chemotherapy to wipe out the faulty immune system.
- Reintroducing the stem cells to form a fresh immune system.
In theory, this new immune system will no longer:
- Trigger gut inflammation
- Attack drug compounds before they can work effectively
Expert Perspective on Stem Cell Research
Professor Tom Walley, Director of the NIHR Evaluation, Trials and Studies programs, emphasized the importance of the trial:
“Stem cell therapies are an important, active, and growing area of research with great potential. There are early findings showing a role for stem cells in replacing damaged tissue. In Crohn’s disease, this approach could offer real benefits for the clinical care and long-term health of patients.”
The ASTIClite Clinical Trial: A Follow-Up Study
The ASTIClite trial is a follow-up to the team’s 2015 “ASTIC” trial, which explored similar stem cell therapy for Crohn’s disease.
Findings from the original trial:
- The therapy did not cure the disease.
- Many patients did experience benefits from the treatment.
- Some patients suffered serious side effects due to the high doses of drugs used.
This follow-up trial will reduce drug doses to minimize risks and improve safety.
Research Collaboration & Recruitment
Patients will be recruited through multiple NHS Trusts, including:
- Barts Health NHS Trust
- Cambridge University Hospitals NHS Foundation Trust
- Guy’s & St Thomas’ NHS Foundation Trust
- NHS Lothian
- Nottingham University Hospitals NHS Trust
- Oxford University Hospitals NHS Foundation Trust
- Royal Liverpool and Broadgreen University Hospital NHS Trust
- Sheffield Teaching Hospitals NHS Foundation Trust
The trial also involves researchers from:
- University of Manchester
- University of Nottingham
- University of Sheffield
- Nottingham Trent University
- University of Edinburgh
- University of Oxford
- King’s College London
- Queen Mary University of London
Funding and Support
The study was funded by a Medical Research Council (MRC) and NIHR partnership created to support:
- Evaluation of innovative interventions
- Promotion of health
- Treatment of diseases
- Improvement of rehabilitation and long-term care
Source
Queen Mary University of London
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