THE first human trial of stem cells on heart patients is to be carried out in Galway within two years.
Timothy O’Brien, director of the Regenerative Medicine Institute (Remedi) in NUI Galway, is preparing tests involving 10 patients suffering from chronic heart conditions. They will have stem cells grafted on to their hearts, to see if this helps to repair the organs.
“These patients have had a heart attack and now have heart failure and diminished function,” said O’Brien. “The hope is that stem cells from their own marrow, which have been grown in culture, can repair the damaged area, avoiding the need for replacement.”
Remedi’s 70 researchers work exclusively with adult stem cells. In the trial these will be extracted from marrow in patients’ pelvises and over three to six weeks hundreds of millions of cells will be grown in the laboratory from a base of 50,000. They will then be grafted into the patients’ hearts.
It is hoped that gene therapy will prove so successful that it will eventually do away with invasive operations and organ transplants.
Cardiovascular disease is the largest cause of deaths in Ireland — accounting for 39% of fatalities in 2003.
“This kind of a dream has been around for 40 years,” said Brian Maurer, medical director of the Irish Heart Foundation. “It would solve one of our major problems. We have nowhere near enough donors at present for transplants and any alternative treatment is to be welcomed. The beauty of this treatment is that it would not be limited by the number of donors available.
“It is very exciting to hear that they could be ready to start human trials within 18 months. They have amassed a huge amount of technical expertise. This puts them at the front of world research into treatments for cardiac conditions.”
Maurer cautioned against expectations of the treatment becoming widely available in the next few years. “Progress is likely to be slow as there are a huge number of technical difficulties,” he said.
The Irish Medicines Board (IMB) said Remedi’s application to carry out trials would be approved if it meets a range of criteria covering quality, safety and effectiveness.
“A number of conditions apply to the granting of the clinical trial licence and these include regular updates to the IMB on progress and reporting of adverse reactions,” it said.
Remedi was established in 2003 by Science Foundation Ireland (SFI) with an investment of €15m over five years. A further €4m comes from Medtronic and Charles River Laboratories. The success of the first five years will be assessed by SFI before more funding is provided.
The stem cell researchers spent their first year recruiting experts from around the world and say that they are focused on translating laboratory work into new treatments.
Remedi’s researchers have also genetically engineered stem cells to eliminate inflammation in the paws of mice which induced arthritic-like conditions. They hope this treatment will eventually be used to alleviate the pain of those who suffer rheumatoid arthritis.
