US doctors have begun the first official trial of using human embryonic stem cells in patients after getting the green light from regulators.
The Food and Drug Administration has given a license to Geron to use the controversial cells to treat people with spinal injuries.
The cells have the potential to become many of the different cell types found in the body, including nerve cells.
The trials at a hospital in Atlanta will check if the treatment is safe.
The landmark trial involves spinal injury patients who have been given cells from human embyros at a US clinic.
Scientists last night hailed the tests – which follow President Obama’s decision to relax US rules on stem cell research – as the start of a new era.
Professor Chris Mason, head of regenerative medicine at University College London, said: “This first in man study marks the dawn of the stem cell age.”
The current work by the US-based Geron Corp involves embyros left over from fertility treatment.
It could eventually lead to the development of a host of new treatments, including the reversal of spinal injuries.
The results of the procedure, carried out by privately funded company Geron, will be awaited eagerly around the world by doctors and scientists working in regenerative medicines.
Stem cells
If a success it could be the “catalyst” to open up stem cell treatments for all kinds of conditions from nerve damage, to Alzheimer’s disease to diabetes.
Professor Chris Mason, an expert in regenerative medicine at University College London, said it marked the dawn of the “Stem Cell Age”.
“This pivotal clinical trial is a major morale boost for scientists, clinicians and most of all patients by finally commencing the transformation of stem cells from a scientific curiosity into advanced health care,” he said.
Geron said that the patient had requested to remain anonymous and would not release any further details, even of age and sex.
However to qualify for the study, he or she must have suffered a paralysing spinal cord injury no more than 14 days before being treated, otherwise it would not be so effective.
Millions of embryonic stem cells, which come from human embryos left over from fertility treatments, were injected into the damage area.
The hope is that they will travel to the site of a recent spinal cord injury and transform into damaged nerve cells and help the cord regenerate.
The Phase I trial, carried out at the Shepherd Centre in Atlanta, Georgia, will not be aiming to cure patients but to establish that the cells are safe to use and that there is no adverse side-effects.
Thomas Okarma, chief executive of Geron, said in a statement it was a “milestone for the field of human embryonic stem cell-based therapies”.
“When we started working with human ES cells in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials.”
Embryonic stem cells are master cells found in human embryos, which give rise to more than 200 specialised types of tissue in the adult body, and can be grown into any kind of tissue to replace cells damaged by injury or disease.
Use of embryonic stem cells is controversial because they must be harvested from human embryos that are destroyed in the process.
This has raised moral objections from those who believe that embryos have the same rights as humans and see the treatment as unethical.
The issue is especially acute in the US, where it has become an issue for “pro-life” groups.
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A research from Rockefeller University has Identified a gene that can inhibit stem cells from developing into cancer.
Having too many stem cells, or stem cells that live for too long, can increase the odds of developing cancer.
By identifying a mechanism that regulates programmed cell death in precursor cells for blood, or hematopoietic stem cells, the work is the first to connect the death of such cells to a later susceptibility to tumors in mice.
Research associate Maria Garcia-Fernandez, Hermann Steller, head of the Strang Laboratory of Apoptosis and Cancer Biology, and their colleagues explored the activity of a gene called Sept4, which encodes a protein, ARTS, that increases programmed cell death, or apoptosis, by antagonizing other proteins that prevent cell death.
To study the role of ARTS, the experimenters bred a line of mice genetically engineered to lack the Sept4 gene.
Newborn ARTS-deprived mice had about twice as many hematopoietic stem cells as their normal, ARTS-endowed peers, and those stem cells were extraordinary in their ability to survive experimentally induced mutations.
Indeed, the ARTS-deprived mice developed spontaneous tumors at about twice the rate of their controls.
“We make a connection between apoptosis, stem cells and cancer that has not been made in this way before: this pathway is critically important in stem cell death and in reducing tumor risk,” Steller said.
ARTS interferes with molecules called inhibitor of apoptosis proteins (IAPs), which prevent cells from killing themselves. By inhibiting these inhibitors, under the right circumstances ARTS helps to take the brakes off the process of apoptosis, permitting the cell to die on schedule.
The study will be published in Genes and Development.
Only eight people will take part in the first known clinical trial testing the safety of embryonic stem cells in humans and each patient will go through a very stringent selection process, the lead researcher of the study said on Monday.
“I think it’s likely that 50 percent or even 75 percent of patients we evaluate will not meet the criteria,” Dr. Richard Fessler of Northwestern University and Northwestern Memorial Hospital, who is leading the trial sponsored by Geron Corp.
Geron has the first U.S. Food and Drug Administration license to use the controversial embryonic stem cells to treat people — in this case patients with new spinal cord injuries.
The company announced on Monday that the first patient had started treatment at a rehabilitation hospital in Atlanta. Northwestern is the only other site ready to enroll patients.
“What will happen is some individuals will experience some kind of spinal cord injury,” Fessler said in a telephone interview.
If the injury is the right kind — the spine is crushed but not severed, the patient does not have an infection or a history of cancer and if the injury occurs in the right spot in the middle of the back — the patient’s doctor might recommend they be included in the trial.
From there, people will be evaluated to see if any metal rods or screws used to stabilize the spine obstruct the view of the spinal cord on an advanced type of scanner called a magnetic resonance imaging or MRI machine.
Patients offered a chance to be in the trial have only 11 days from the time of their injury to decide, Fessler said.
“We have to transplant them within 14 days of the injury,” Fessler said. “We have three days of preoperative testing we have to do before we can do the transplant. They have to be given the offer and make their decision by day 11.”
OFFERING ADVICE
All patients will have an independent patients’ advocate standing by to make sure they are not pressured to take part in the study.
And in many cases, patients may want to seek the advice of clergy to help them think through any ethical concerns they may have in being injected with human embryonic stem cells, Fessler said.
Embryonic stem cells come from days-old embryos and can produce any type of cell in the body.
Opponents of their use say it is wrong to make the cells because they involve the destruction of an embryo. Geron’s cells are made from embryos left over after in-vitro fertilization attempts at fertility clinics.
Supporters believe it is equally wrong to let the embryos be destroyed.
A patient with a damaged spinal cord has become the first to be injected with embryonic stem cells in a landmark clinical trial of the therapy.
The controversial and long-awaited trial was given the green light by the US Food and Drug Administration in January last year, and is being organised by Geron, a biotech company based in California.
Doctors hope that injecting stem cells directly into the spine will help repair damaged nerve cells enough for paralysed people to regain some movement, but such treatments have yet to be tested in humans.
Though preliminary, the launch of the trial marked the “dawn of the stem cell age,” according to one British stem cell researcher.
The patient, who has not been named, was treated on Friday at the Shepherd Centre, a specialist spine and brain injury unit in Atlanta, Geron said in a statement released today. The centre is one of seven potential sites in the US that can enroll patients for the trial.
In the trial, patients who have received a spinal injury within the past 14 days will be injected with living cells that are precursors of a kind found in the nervous system. The cells are expected to infiltrate the site of the injury and release chemicals that help repair damaged spinal cord nerves.
Tests in animals show that injections of the cells can improve their ability to walk and move after sustaining an injury.
“When we started working with human embryonic stem cells in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials,” said Thomas Okarma, Geron’s president and CEO. The trial has triggered objections from some religious groups because the cells are derived from spare embryos created at IVF clinics.
http://www.guardian.co.uk/science/2010/oct/11/stem-cell-trial-spinal-cord