From: Brett Paatsch (paatschb@optusnet.com.au)
Date: Mon Jun 16 2003 - 09:02:46 MDT
Extropes,
I'm forwarding this post from a Stem cell list I subscribe to.
Scary stuff, but instructive, I think, of the need for us to be
informed and to engage in discussion on techonolgy with
society in general. The alternative seems to be drowning
amidst fools in oceans of ignorance.
Regards,
Brett
--------------------
The kid doing well enough he's on vacation, and the FDA has asked Beaumont Hospital not to do any more similar surgeries.
http://www.detnews.com/2003/health/0306/13/d01-192073.htm
Friday, June 13, 2003
New stem cell surgery on hold
By Mike Martindale / The Detroit News
ROYAL OAK -- The federal government has told doctors at Beaumont Hospital not to perform any more stem cell surgeries just four months after they made international news by removing a nail from a teen-ager's heart and repairing it with stem cells from the blood in his leg.
"It's a huge disappointment, a real tragedy," said Dr. William O'Neill, Beaumont's head cardiologist, after the U.S. Food and Drug Administration ordered Beaumont not to repeat such a surgery despite the teen's rapid recovery and a list of 400 other patients eager to try the experimental procedure.
"About 1 million people each year in this country survive massive heart attacks, and realistically 25 percent have serious heart damage," he said. "About 100,000 to 200,000 people a year could benefit from this."
The surgery, which took less than an hour, likely saved the life of Dimitri Bonnville, 16, of Almont, who was working at a Lapeer County construction site Feb. 1 when he was shot in the heart with a nail gun. A 20-year-old co-worker has been charged with assault to do great bodily harm less than murder.
Doctors were able to remove a 3-inch-long nail from Bonnville's heart, but he suffered a massive heart attack that destroyed about one-third of his muscle cells, making it difficult for his heart to beat.
It was determined Bonnville's condition would likely worsen and he would eventually require a heart transplant. Based on lab studies that showed stem cells from the blood hold promise in helping to repair damaged hearts and other studies that show stem cells from bone marrow can also improve the heart function, a treatment protocol was devised by Beaumont doctors.
On Feb. 17, doctors began giving Bonnville a four-day regimen of the drug Neupogen to stimulate the production of stem cells in the blood.
On Feb. 21, doctors harvested his stem cells with a special blood collection machine and, using a heart catheter, transplanted stem cells to his left anterior descending artery, which supplies blood to the front of the chest.
Five days after the stem cell transplant, a defibrillator was implanted in Bonnville's chest to help control any irregular heartbeats. By Feb. 24, his heart had returned to 70 percent of normal capacity.
Today, Bonnville is somewhere on vacation with his family, celebrating his 17th birthday. His progress has been so dramatic, doctors believe the defibrillator will be removed later this year.
Meanwhile, the FDA, which contacted Beaumont within 24 hours of the procedure about an official inquiry, deemed the surgery too unproven and risky for humans.
The FDA does not discuss applications for new treatments, such as proposed by Beaumont. But Martin McGlynn, chief executive of StemCells Inc., a biotech company in Palo Alto, Calif., said federal regulators have no alternative.
"The laws and regulations are clear, and it would be a disservice to society for them (FDA) to act otherwise," said McGlynn. "There will always be patients willing to take risks on unproven procedures, but in areas like stem cells, it is something that must be carefully studied."
Beaumont officials said there are other options for people with serious heart problems, including transplants.
Beaumont was advised that extensive animal experimentation and human dosage trials would be needed before Beaumont's procedure would be considered for FDA approval.
"It would take us about two years to do that," O'Neill said. "We received such a response last February that this (procedure) is now under way in Europe and South America. We will instead review the human data from those countries."
Beaumont officials said they didn't initially feel FDA approval was necessary because bone marrow transplants are routinely used to treat cancer patients.
"The real concern is that people want to experiment with cells from embryo eggs, and then you get embroiled in the right-to-life controversy," O'Neill said. "That's why Congress enacted laws and FDA has the power to approve or deny.
"But even the lay person can see the difference in using your own cells to repair yourself rather than that of a fetus."
The hope was that the transplanted blood cells would regenerate Bonnville's damaged heart and stimulate new blood vessel growth. So far, it seems to be succeeding.
You can reach Mike Martindale at (248) 647-7226 or mmartindaledetnews.com.
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http://groups.yahoo.com/group/CNS_Healing
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