A new UK trial is to test the use of stem cell transplants to grow new immune systems for people with untreatable Crohn’s disease, was announced today.
Researchers hope that if the ASTIClite’ clinical trial is successful, resetting the immune system could reduce gut inflammation and help those for whom other treatments have not worked.
It follows the 2015 ‘ASTIC’ trial, which investigated a similar stem cell therapy. Although the original trial did not cure the disease, the team found that many patients benefitted from the treatment.
However, there were also some serious side effects from the doses of drugs used. This new trial will use a lower dose of the treatment to minimise risks due to toxicity.
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.”
The trial, which follows a successful study in which stem cell transplants treated people with multiple sclerosis, will see patients undergoing chemotherapy and hormone treatment to mobilise their stem cells, which are then harvested from their blood.
Further chemotherapy kills their faulty immune system and stem cells are re-introduced back into the body, they develop into new immune cells which give the patient a fresh immune system.
It is hoped the new immune system will not react adversely to the patient’s own gut.
Professor Tom Walley, director of the NIHR Evaluation, Trials and Studies programmes, which funded the £2 million trial with the Medical Research Council, said: “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 trial is being led by Queen Mary University of London and Barts Health NHS trust and will involve academics from the University of Manchester, University of Nottingham, University of Sheffield, Nottingham Trent University, University of Edinburgh, University of Oxford, and King’s College London.
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