U.S. trial marks dawn of the ‘stem-cell age’
The experiment in the United marks a big step forward for the field and, if all goes well, couldopen the door to therapies that promise to heal traumatic injuries.
Stem cells, the precursors to the other cells inour body, can regenerate and help repair tissue. In the experiment, thecells are expected to coat the damaged spinal cord and repair thenerves. If successful, the treatment is supposed to allow the patient toregain some of the movement lost due to injury.
Scientists aroundthe world are watching the results closely, with British researcherChris Mason telling reporters the trial marks “the dawn of the‘stem-cell age.’ ”
“Without question, this represents a majorlandmark, it’s a new threshold we’re passing through,” said MichaelRudnicki, scientific director of Canada’s Stem Cell Network. “It’s avery important trial and I hope it will be successful.”
Stem-cellresearch has long been controversial, particularly among religiousgroups, which oppose the destruction of human embryos. The field alsocarries significant risks, as some cells have been shown to spark thegrowth of tumours. The sheer cost of weeding out cancer-causing cellshas made it difficult for researchers in other countries to mount such atrial.
The unidentified patient underwent the therapy Friday atthe Shepherd Center, an Atlanta rehabilitation hospital and researchcentre. The trial, sponsored by California biotech firm GeronCorporation, will perform the experiments on up to 10 people who havesuffered traumatic spinal cord injuries less than two weeks before thetherapy. The tests will determine whether the cells are safe for use inhumans.
While clinics in China and other countries use humanembryonic stem cells in treatments, the U.S. trial is the first toclosely document the process to assess its risks, experts said.
Geronspent years trying to get the trial off the ground. The company had todemonstrate to the U.S. Food and Drug Administration that it couldperform the therapy with little risk of giving the subjects cancer.Geron also raised ethical concerns by opting to perform the trial onpatients who had suffered traumatic injuries mere days before.
After several rounds of animal testing, the FDA approved the human trial in July.
“Whenwe started working with [human embryonic stem cells] in 1999, manypredicted that it would be a number of decades before a cell therapywould be approved for human clinical trials,” said Geron chief executiveofficer Thomas B. Okarma in a statement. “This accomplishment resultsfrom extensive research and development.”
The U.S. has seen vigorous debate between scientists and the religious right over the use of stem cells. Former U.S. president George W. even imposed restrictions on federal funding for such research. As aprivate company, however, Geron was able to continue its work.
Andwhile other countries have a more relaxed attitude toward stem-cellresearch, researchers say the U.S. is the only place where companieshave been able to raise the money needed to perform trials.
Despiteits relatively small size, Canada is among the countries leading instem-cell research, but most research focuses on adult cells. Canadianresearchers have made significant advancements in isolating cells in theretina that can aid in treating eye disease and developed a method fortreating a type of high blood pressure that involves using the patient’sown blood cells to repair their arteries.
In another advance, ateam at McGill was able to take stem cells from skin and turn them intobrain cells. The use of cells taken from a patient’s own body helpscircumvent ethical issues involved in such research and avoid thepossibility of the body rejecting cells.
“It doesn’t have theethical issues of embryonic stem cells and you can transfer them intothe patient without fear of immune rejection,” said Mick Bhatia, astem-cell researcher at McMaster University who primarily works on adultcells.
While that technology is more difficult for Geron to use,thanks to intellectual property restrictions, experts believe it willeventually supplant embryo-derived stem cells in research.
Stem cells were first identified at the University of Toronto in the 1960s.