Important Crohn's research, begins clinical trials.

We're excited for start of clinical trials which will use stem cell transplants to grow a new immune system for people with untreatable Crohn’s disease – a painful and chronic intestinal disease which affects at least 115,000 people in the UK.

The study, led by Queen Mary University of London and Barts Health NHS trust, is funded with £2m from a Medical Research Council and National Institute for Health Research partnership.

The latest trials follow related research into stem cell transplants, led by the same Chief Investigator, which was funded by us and finished this year.

Crohn’s disease is a long-term condition that causes inflammation of the lining of the digestive system, and results in diarrhoea, abdominal pain, extreme tiredness and other symptoms that significantly affect quality of life.

Current treatments include drugs to reduce inflammation but these have varying results, and surgery is often needed to remove the affected part of the bowel. In extreme cases patients may require a final operation to divert the bowel from the anus to an opening in the stomach, called a stoma, where stools are collected in a pouch.

Many patients often treatments ineffective.

Chief investigator Professor James Lindsay from Queen Mary University of London and a consultant at Barts Health NHS Trust said: “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 in some and others may not want to consider this approach.

“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.”

Helen Bartlett, a Crohn’s disease patient who had stem cell therapy at John Radcliffe Hospital, Oxford, said:

Living with Crohn’s is a daily struggle. You go the toilet so often, you bleed a lot and it’s incredibly tiring.

“I’ve been in and out of hospital for the last 20 years, operation after operation, drug after drug, to try to beat this disease.

“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.”

The use of stem cell transplants to wipe out and replace patients’ immune systems has recently been found to be successful in treating multiple sclerosis. This new trial will investigate whether a similar treatment could reduce gut inflammation and offer hope to people with Crohn’s disease.

The trial will involve intense treatment for participants.

In the trial, patients undergo chemotherapy and hormone treatment to mobilise their stem cells which are then harvested from their blood. Further chemotherapy is then used to wipe out their faulty immune system. When the stem cells are re-introduced into the body, they develop into new immune cells which give the patient a fresh immune system.

In theory, the new immune system will then no longer react adversely to the patient’s own gut to cause inflammation, and it will also not act on drug compounds to remove them from their gut before they have had a chance to work.

The current clinical trial, called ‘ASTIClite’, is a follow up to the team’s 2015 'ASTIC’ trial, which investigated a similar stem cell therapy.

We funded related research which took place between the two ASTIC projects. Professor James Lindsay said of our involvement:

Bowel & Cancer Research funded some earlier work which investigated whether we could predict who is going to respond well to stem cell therapy and who won't. That work has laid the blueprint for the mechanistic analysis which is built into the current NIHR-funded ASTIClite trials. We are extemely grateful to Bowel & Cancer Research for its support.

We're excited to see how this trial progresses and will provide updates as the trial continues.

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