The game may almost be up. No, not Saddam’s duplicitous charade, although his tyrannical regime seems to be on the brink of a much-needed dismantling. Rather, the New York Times has prominently reported a story about an apparently successful treatment of a human patient with his own adult stem cells. Perhaps now the stubborn assertion by Big Biotech and some patient groups that the future of regenerative medicine lies primarily with embryonic stem cells and therapeutic cloning is finally beginning to unravel.
Here’s the scoop: On February 1, a three-inch nail pierced 16-year-old Dimitri Bonnville’s heart. The injury was severe. Then, Bonnville suffered a serious heart attack, putting his life at real risk. Since the accident, his heart had, according to doctors, “shown progressive degeneration,” and his “ejection fraction, a common measure of the heart’s function, had fallen from a normal value of more than 65 percent to a mere 25 percent.” (Ejection-fraction measures the amount of blood pumped out of the left ventricle with each beat.)
Luckily for Bonnville, his physicians were planning to begin a clinical trial using adult stem cells to repair damaged hearts. But Bonnville’s need was immediate. And, being young and otherwise healthy, he seemed the perfect subject. So, his doctors developed a “one patient protocol,” in which they undertook to treat the teenager with his own tissues.
Stem cells were first extracted and isolated from Bonnville’s blood. Then, they were injected into the coronary artery that supplies blood to the heart. A few days later, doctors noted an astonishing improvement. Bonnville’s ejection fraction had risen to 35 percent, despite previous tests revealing that Bonnville had “no viable heart muscle” in the affected area.
Of course, one patient does not a new cure make. It will still be months before tests confirm that Bonnville is rebuilding heart muscle. Moreover, it will take much more research — with animals and in human clinical trials — before adult-stem-cell therapies will be ready to be added to medicine’s arsenal as a treatment for heart disease. Still, similar experiments in Germany and Hong Kong using bone-marrow stem cells have demonstrated that adult-stem-cell therapy appears to induce new heart muscle to grow in place of dead tissue — something that until very recently doctors did not believe could happen.
The news of Bonnville’s improvement was so good that the doctors felt compelled to hold a press conference about the matter. In what may prove to be a sea change, the New York Times reported the story with appropriate prominence. This was unexpected, given that the Gray Lady has too often ignored or underplayed previous adult-stem-cell successes while touting less impressive experiments using embryonic stem cells in animals with great enthusiasm.
A good case in point was the Times’s dismaying failure last April to cover a major adult-stem-cell success story involving a Parkinson’s disease patient, a California man named Dennis Turner. As reported by Dr. Michel F. Levesque to the American Association of Neurological Surgeons, the California neurosurgeon had treated Turner for his progressing Parkinson’s with Turner’s own neural stem cells. First, a pea-sized sample of tissue was removed from Turner’s brain. Then, stem cells in the tissue were isolated and cultured into the millions. Finally, the cells were injected back into Turner’s brain. One year after the procedure, the patient’s symptoms were reduced by more than 80 percent — even though Turner was treated in only one brain lobe.
I interviewed both Turner and Dr. Levesque about this astonishing experiment. Had the Parkinson’s progressed as expected, they both told me, Turner would be expected to require heavy medication to treat his symptoms and would likely be using a wheelchair in which he would have to be strapped. Instead, he takes only minimal medication — less than he was using when he received the experimental treatment — and his symptoms remain decidedly mild. Indeed, Turner told me that he only experiences minor hand trembling, and then only when he is under stress or very tired. The proof of how his life has improved is that, when I interviewed him last September, Turner was in the midst of planning a trip to the South Seas to participate in a great-white-shark photography expedition — something he is convinced he would be unable to do but for receiving the stem-cell procedure.
Once again, it must be stressed that one patient does not a cure make. It is possible that Turner’s disease would not have followed the usual progression; furthermore, there may be another reason for his apparent remission. Still, there is no denying that Turner’s results offer great reason for optimism. Levesque has been authorized by the FDA to conduct further human trials once certain animal studies have been completed and his laboratory has been upgraded.
Cases such as Bonnville’s and Turner’s, while still isolated, are becoming increasingly common. Tremendous strides are being made in animal studies and now in human patients, harnessing adult stem cells and other tissues — such as nasal mucosa — as medicine for degenerative conditions. In contrast, embryonic stem cells remain many years from the first human trials — if they can ever be conducted at all. It is too dangerous to use embryonic stem cells in humans because they tend to cause tumors. Moreover, they may be rejected by the body’s autoimmune system. As for so-called “therapeutic cloning,” which some look to in order to overcome the rejection — but not the tumor — problem: The New York Times itself on January 5 ran an article concluding that any medical benefit to be obtained from cloned human embryos, even if it can be done, is “all in the distant future.”
Some patients with degenerative conditions have taken notice of the growing list of adult-stem-cell research successes. Among these is James Kelly, who became paraplegic after a terrible auto accident. No longer able to work as a railroad dispatcher, Kelly is now a committed patient-advocate who spends 10-14 hours a day researching regenerative medicine and potential treatments for his nerve injury.
He used to support embryonic-stem-cell research — even writing a letter to President Bush in support of federal funding. But he has since changed his mind. Based on extensive reading and investigation, Kelly is thoroughly convinced that his best hope to walk again is to be found in using his own adult tissues as medicine. He also believes that outlawing all human cloning, while certainly the moral course, is also the pragmatic one that offers people like him the best opportunity for treatment in the shortest period of time.
“We don’t have to go down long paths that will probably not lead to any cures simply for the sake of leaving no stone unturned,” he told me, with passion in his voice. “What we have to do is use our limited resources efficiently. Money spent on embryonic-stem-cell research and human cloning is money that cannot be spent on [investigating] adult stem cells. And that means that the cures that I believe are available will be slower in reaching the patients that need them.”
He has testified to this effect repeatedly in recent years before state and federal legislative committees. Unfortunately, because Kelly is not a movie star, his voice has often been ignored. But his words are worth heeding. He has as much at stake as do celebrity advocates like Christopher Reeve and Michael J. Fox, who make headlines taking the contrary view. Moreover, having personally researched these issues intensively for years, he possesses greater depth and scope of knowledge about these issues than any of his famous counterparts.
Unfortunately, the biotech-research establishment and the patient groups it has influenced are not yet ready to take Kelly’s sage advice and abandon research into human cloning. But the trend-line of the research results is becoming increasingly difficult to ignore. As Kelly has repeatedly asserted, the shortest and most likely route to the creation of a thriving regenerative medical industry appears to lie not with embryonic stem cells derived from human cloning, but with adult stem cells and other non-embryonic tissues.
This is tremendous news. A new era appears to be dawning in which our own cells will be the sources of very potent medicine. Rather than having to choose between morality and the wonders of regenerative medicine, it increasingly looks like we can have both.