Thursday, Nov. 3, 2005 | 8:01 a.m.
Dr. Alfred Sapse calls his ideas "controversial."
That's one way of putting it. Other scientists call them quackery.
Sapse claims to know about a revolutionary technique of using stem-cell transplants to cure a variety of diseases -- without the politically charged destruction of human embryos. And he plans to push the Nevada Legislature to legalize his method.
"Right now, you have the scientific world saying, 'We have a revolution in progress, but it will take 15 or 20 years,' " Sapse said.
"On the other hand, you have millions of people saying, 'No, we want the stem cells now.' ... I'm going to ask the Legislature for permission to open a stem cell clinic in Las Vegas."
Sapse's proposed treatments involve implanting patients under the skin with cells harvested from placentas. He says he worked with such a treatment in Eastern Europe in the 1950s, long before the concept of "stem cells" even existed.
The treatment involved drying human placentas in an oven and implanting pieces of tissue under the skin of people with a variety of diseases.
"About 5,000 people took the treatment in 1951 in Odessa," in the then-Soviet republic of Ukraine, Sapse said.
The results astonished the scientists, he said. People whose bodies had been devastated by multiple sclerosis rose from their wheelchairs and took halting steps; people whose eyes were succumbing to macular degeneration could make out images.
Stem cells -- one of the hottest topics in both science and politics -- are the immature cells that form the basis of human development, with the ability to generate the specialized tissues and organs that make up the human body.
Stem cells taken from human embryos are controversial because some say harvesting them means destroying a potential life. But stem cells also are found in bone marrow, umbilical cords and the placenta, the organ that connects the fetus to the uterus and is expelled at birth.
Although his ideas resemble some cutting-edge research currently being done, Sapse's claims are far-fetched, experts say.
"You just don't say, 'I discovered a stem cell, now I'm going to shoot people up with it,' " said Stephen Strom, an associate professor of pathology at the University of Pittsburgh who has published the most advanced research into placenta-derived stem cells.
"We have data to suggest that this (placenta cells) would be a useful therapy, but we haven't proved it yet," Strom said. If such a therapy is proved, he added, it is doubtful that it will be as easy as a simple implant under the skin.
Given the early stage of such research, Strom said, claims like Sapse's are dangerous.
"The people who may benefit from many stem-cell therapies are frequently out of other options," Strom said. "These people are desperate. ... One cannot take advantage of these people, even though they beg for the new therapy and a shortcut around regulatory issues. It is absolutely unethical to do this."
There is reason to take Sapse seriously when he says he can convince the Legislature. It wouldn't be the first time.
In the 1970s Sapse played a role in convincing Nevada to legalize Gerovital, a so-called miracle drug, against the advice of the U.S. Food and Drug Administration.
The 80-year-old Sapse is a native of Romania, where he says he received his medical degree and certification in ophthalmology.
He came to the United States in the 1960s and worked as a microbiology researcher at UCLA from 1969 to 1972. During that time, he co-authored several papers in respected medical journals on the properties of tears, according to publication databases.
But Sapse then left academe and moved to the fringes of the medical establishment by seeking to prove the effectiveness of Gerovital, a purported cure for aging for which numerous Americans, including many celebrities, traveled abroad in the 1970s. Invented in Romania by a mentor of Sapse, the drug's active ingredient is procaine hydrochloride, commonly known as Novocain.
In 1971 Sapse and a friend co-founded Rom-Amer Pharmaceuticals and set about seeking FDA approval for the substance, according to an article in the Wall Street Journal in 1977, headlined, "Gerovital: rejuvenator or snake oil?"
When the FDA wasn't convinced, Rom-Amer teamed up with Marvin Kratter, a real estate tycoon and former owner of the Boston Celtics and hired some of Nevada's top lobbyists. The debate over the drug in the Nevada Legislature became a national controversy.
In 1977 Nevada legalized Gerovital over the FDA's objections. As a federal agency, the FDA may only regulate substances involved in interstate commerce. As long as Gerovital was manufactured and consumed in Nevada, the federal government was powerless.
Sapse resurfaced in the news in 1997, when another company he founded won FDA approval to test an anti-AIDS drug on humans. AIDS researchers were skeptical of the substance, which appeared to have ingredients in common with Gerovital.
The trials of the anti-AIDS drug were apparently never completed, and Sapse left the company amid litigation.
As for Gerovital, it is still legal in Nevada and still banned by the FDA. Numerous studies over the years have not shown it to have any therapeutic effect, and the mainstream medical establishment regards it as a scam.
However, there is still a vocal contingency of anti-government conspiracy theorists supporting it and other remedies. Such proponents believe that the FDA, through timidity, arrogance or corruption, has conspired to keep life-saving therapies from the American public.
Many of the same people also believe in amygdalin, a supposed cancer treatment extracted from apricot seeds that is also known as Laetrile. Laetrile was legalized in Nevada in the same bill with Gerovital in May 1977.
Laetrile, which also has never been approved by the FDA, is also widely regarded as snake oil. According to the American Cancer Society, "There is no reliable scientific evidence that Laetrile is effective in treating cancer or any other disease. It contains a small portion of cyanide, and several cases of cyanide poisoning have been linked to its use."
The FDA also has not approved any kind of stem-cell treatment, and offering such treatment in the United States would be illegal, said Julie Zawisza, a spokeswoman for the federal agency.
To be approved, a therapy would have to get FDA permission to go through structured clinical trials. Then, once those tests showed it to be safe and effective, it could be licensed for marketing, she said. The entire process would probably take several years.
Zawisza said she was not sure whether the process could be avoided by having a state independently legalize a treatment.
The agency has seen offerings of purported stem-cell therapy before, Zawisza said. "We would be dubious of someone making such a claim because there are no FDA-approved stem-cell therapies at this time," she said.
That has not stopped Americans from going abroad for dubious transplants, however.
In June, a German newspaper reported that Roy Horn, the illusionist who was mauled by a tiger during his Las Vegas show in 2003, visited a German clinic in order to undergo an experimental transplant of stem cells from pig embryos.
Horn has never publicly acknowledged receiving the transplant, but he was under the care of the late Dr. Albert Scheller, a stem-cell specialist who had reportedly performed transplants in the Dominican Republic. Scheller died of heart disease in August at the Mirage.
As part of a Pulitzer Prize-winning series of articles on stem-cell research, Boston Globe reporter Gareth Cook investigated one of the many clinics outside the United States that purport to offer stem-cell treatments.
Such clinics have attracted scores of desperate patients who have been told their diseases are incurable. Cook followed the Massachusetts family of a boy with muscular dystrophy to a clinic in Kiev, Ukraine, where they paid tens of thousands of dollars for treatments.
Cook interviewed 13 patients who had visited the clinic and could find no evidence that the treatments had helped anybody. More disturbingly, he wrote, the clinic made no effort to support its claims by tracking patient data.
American scientists, Cook wrote, called the clinic "a poorly documented operation that appears to be capitalizing on the excitement surrounding stem cells at the expense of desperate families."
Sapse says that his work with placentas occurred at the Filatov Institute of Eye Diseases and Tissue Therapy in Odessa, Ukraine. He said more than 40 papers were published based on the work conducted there, but he did not supply copies of these publications, which do not appear in databases or on Sapse's curriculum vitae.
As Sapse explains it, the doctors in Odessa did not know why their placenta treatment worked, only that it had amazing effects on stubborn conditions such as Parkinson's, Alzheimer's and lupus -- "some of the most worrying names of diseases," Sapse said.
It was only decades later that Sapse read an article about stem cells and made the connection. "I realized that what I was doing was treating people with stem cells. It so happens that the placenta is the richest source of stem cells," he said.
While excellent stem-cell research is being done in the United States today, Sapse says he believes it is fundamentally misguided. Most stem-cell research has focused on cells from embryos or bone marrow.
Embryonic stem cells are controversial because of their potential for life. In addition, scientists believe direct implants of embryonic stem cells may cause tumors. Bone-marrow stem cells pose other difficulties because they must be grown in a lab after extraction.
Placenta stem cells have none of these problems, Sapse said. Implanted directly in the body, they are able to repair any damaged organ or system, he said.
"The bottom line is, what I know about stem cells is better (than other methods) and very cheap," he said.
Because his method is so important, Sapse says, it must be made available to the public immediately, and he hopes he can get Nevada lawmakers to agree.
Lois Vincent, a 78-year-old with multiple sclerosis who lives in a rest home in Mesa, Ariz., is one of a few people circulating a petition in support of legalizing Sapse's treatment.
"I am so anxious to get this treatment," Vincent said. "I've had MS for 18 years, and it's pretty bad." Vincent said she has lost the use of the right side of her body and sometimes experiences spasms.
Vincent previously traveled to Mexico for an injection that purported to consist of umbilical-cord stem cells. At first, she said, the shot made her feel much better, but within six months the effect had faded.
Despite that disappointment, Vincent believes in Sapse's method.
"He told me, 'In three days, you'll be well,' " she said. "I don't want to wait any longer."
Vincent said she's willing to take the risk that Sapse's transplants might not be safe.
Sapse plans to gather petitions from people like Vincent and present them to Nevada legislators until he finds someone willing to sponsor a bill.
"We have to have this here, and it is in the power of the legislators to come up with a law," Sapse said.
Asked whether such a law would merely be a way of circumventing the federal regulatory process, he said, "It is not circumventing. It is exercising the power of each state to do what's best for its citizens."
Strom, the Pittsburgh researcher who is investigating placenta cells, said Sapse's story sounds suspicious.
Important research conducted out of Western view and forever lost behind the Iron Curtain is a common claim of medical charlatans, he said.
But people who have no other hope will always -- understandably -- grasp at supposed miracles, Strom said.
"Since our paper (on placenta stem cells) came out, you wouldn't believe the tragic e-mails we get from people who want a stem-cell transplant today," Strom said. "One stroke victim keeps writing and writing.
"My heart goes out to these people, but we just can't do it with what we know now."
Strom said the methods Sapse describes for extracting stem cells from placentas sound too simple to work. When stem-cell therapies are eventually developed, he said, the cells will have to be isolated with a specific protocol and extracted under controlled conditions.
If placentas were merely dried in an oven as Sapse described them being prepared in Odessa, the cells would die, Strom said.
Once the living cells are extracted, Strom said, he expects they would have to be implanted at the specific sites they are supposed to repair. One probably could not just stitch a piece of placenta into a patient's shoulder and watch the cells magically migrate to the location of whatever organ happened to be diseased, he said.
However, without the reputable research to back up any kind of stem-cell transplant, it is impossible to know what such a procedure will consist of and whether it will be safe and effective. That, Strom said, is the most important issue.
"There are safety issues that should be addressed before any product, cell or compound gets injected or transplanted into patients," Strom said. "These issues are not trivial, nor are they unnecessary."
But Sapse has no patience for such time-consuming procedures, believing they push treatments needed today too far into the future.
"I'm taking my hat off to the research done in the United States on stem cells. It's beautiful," Sapse said.
"But they promise that eventually some treatment will be found, maybe in 10 years, and even then it will have to go through the regulatory agencies and get approved - so maybe there will be a treatment in 15 or 20 years.
"But there are millions of people not in the mood to wait 15 or 20 years, because they will be dead."
Molly Ball can be reached at (702) 259-8814 or at [email protected]
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