Stem Cell Heart Trial Receives Approval

By Nic Fleming, Telegraph, January 24, 2008

Millions of heart attack patients could have their chances of survival boosted and quality of life improved when British surgeons begin their ground-breaking research next month.

During bypass operations, stem cells will be injected into the hearts of patients. The procedures will be carried out by a team at Bristol University.

Earlier this week, The Human Tissue Authority gave Raimondo Ascione, the surgeon leading the research, approval to carry out the trial.

This will be the first large-scale trial comparing patients given the treatment with those given placebo injections, and previous smaller studies have already provided hope that this approach could provide a breakthrough.

Usually because the arteries supplying the heart with blood become blocked with fatty deposits, the heart muscle is starved of oxygen and a heart attack can take place.

Scar tissue can be left behind that no longer contributes to pumping the blood around the body after a bypass operation which is designed to restore the blood supply.

The new study will test the effectiveness of stem cell injections in repairing these scars in patients who have had acute large heart attacks - in which the scarring penetrates more than halfway through the thickness of the heart wall.

Mr. Ascione said yesterday: "We expect that after six months we will have been able to reduce or even make the scars disappear completely.”

"This is the first doubled-blinded, randomized control trial (RCT) trial of its kind to be carried out worldwide.”

"If we can prove the principle that this mechanism works in patients with acute heart attacks, it is likely we could also do the same with the many thousands more who have small or medium heart attacks.”

"This would have major implications for their quality of life and on reducing the costs of treatments for hospitals."

60 patients undergoing heart bypass operations following acute heart attacks will have a type of bone marrow stem cell called CD133+ extracted for use in treatment during the British Heart Foundation funded trial.

Heart muscle cells can be produced using these particular stem cells according to laboratory trials.

Half the patients will be given placebos while the other half will receive injections of the cells during their operation.

To see whether the stem cells have encouraged significant healing of the heart muscle, the study participants will undergo cardiac MRI scans six months following the procedure.

Out of the 230,000 people who suffer a heart attack each year in the UK, one dies. Heart disease is the number one killer in the country.

A trial using a broader group of bone marrow stem cells for injection into the arteries responsible for taking blood to the heart will be conducted by another team led by Professor John Martin at University College London next month. The trial will involve 100 patients.

Professor Martin said: "This is a new phase in stem cell research where we need blinded RCTs to see whether stem cells do work in the real clinical situation."