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By Fred Tasker
September 3, 2011
It’s an aging Boomer’s dream. A woman’s plastic surgeon trims fat from her waist via liposuction, spins it in a centrifuge to concentrate its stem cells and reinjects the cells into her face, breasts and/or buttocks, creating a whole-body makeover in a single, three-hour office visit.
“We can put a youthful blanket of fat over the muscles in the face so you don’t see the crows’ feet anymore,” says Dr. Sharon McQuillan, cosmetic surgeon and founder of the Ageless Aesthetic Institute in Aventura.
The procedure is more than just transfer of fat, which can shift over time. Doctors believe the fat-derived stem cells actually build their own blood vessels and attach permanently in their new location, for a more natural, longer-lasting lift.
It’s the new thing. It doesn’t even need approval by the U.S. Food and Drug Administration.
But that’s both a blessing and a curse.
A blessing, because full FDA phase I, II and III clinical trials for such approval typically take many years and cost millions of dollars. Official stem cell therapy for ailments from heart disease to liver problems needs at least another five years of major university study for that reason.
A curse, because some experts say it the fat stem-cell technique needs more study to prove it’s safe. Letting medical use run so far ahead of clinical trials is asking for trouble, they say.
Still, the practice is expanding.
McQuillan and her team also use their patients’ own fat stem cells in orthopedics, to treat arthritis or sports injuries to knees, shoulders, hips and other joints. Shawn Mann, 39, of Weston, tore the meniscus in his knee in a pickup basketball game last year, and says the injection of his own fat cells into his knee got him back on the YMCA court again.
“The soreness is completely gone,” he says.
Dr. Joseph Purita of Boca Raton says he saved the career of New York Yankees pitcher Bartolo Colon by taking stem cells from his bone marrow and fat stem cells from his stomach and injecting them around the torn rotator cuff in his shoulder.
Such treatments are not regulated by the FDA. The reason: Since the cells are harvested and reinserted into the same patient, and only minimally manipulated in the process, they’re not considered drugs. The FDA only regulates drugs.
Some worry about that.
“It’s not a proven therapy,” says Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine. “Whenever you’re doing something new, it’s important that clinical trials be done.”
Hare — who made clear he was criticizing the idea, not Dr. McQuillan — said he worries that the cells could stimulate growth in unwelcome ways, such as tumors.
“It’s a theoretical concern, but it’s there,” he says.
Donna Arnold, 63, of Delray Beach, says she’s thrilled with the work McQuillan did on her about five weeks ago in her Aventura office — liposuctioning fat from her waist and injecting it in dozens of places in her face.
“I’m like a baby’s tushie,” she said. “The wrinkles are gone. I feel healthier and better. I’m back to exercising every day and taking better care of myself.”
On the other hand, Texas Gov. Rick Perry got himself in hot water with university stem cell specialists by getting stem cell treatment for an aching back that apparently needs FDA approval and doesn’t have it, according to The Boston Globe.
Stem cell treatment is quickly expanding beyond facelifts and knee repair. McQuillan is a founding member of the Regenerative Medicine Institute at Hospital Angeles in Tijuana, Mexico, that is doing stem cell research into 22 diseases — from heart attacks to diabetes to erectile dysfunction. Being outside the United States, it, too, is not overseen by the FDA.
That bothers Dr. Bruce Mast, chief of plastic and reconstructive surgery for the University of Florida Department of Surgery: “If they don’t have the FDA looking over their shoulder, what is the standard of science they use as proof of principle? Is it the same standard we have?”
The cosmetic use of adipose, or fat, stem cells is straightforward, McQuillan says. She removes fat from the patient’s waist by liposuction, spins it in a centrifuge to concentrate its stem cells, adds them back into some of the original fat and injects the mixture into the patient.
It can be done in an afternoon, she says.
Grafting fat for cosmetic purposes is not new, McQuillan says. But concentrating the fat stem cells for reinjection along with some of the fat is only a few years old.
“Fat grafting was never wildly popular because it didn’t get predictable results,” she says. “A year later, only 30 or 40 percent of patients were satisfied. The fat went away, just like commercial fillers.”
Adding the fat stem cells works better because they appear to grow their own blood vessels and collagen matrix and attach better to the new location, she says.
“And it has the added benefit that it regenerates the overlying skin,” she says. That’s because the new blood vessels also feed the skin, she says.
A simple procedure in which McQuillan removes fat by liposuction and injects its stem cells in a patient’s face would cost $5,000 to $7,000; as cosmetic surgery, it would not be covered by insurance.
It doesn’t need FDA approval, McQuillan says, because the patient is injected only with his or her own stem cells, and the stem cells are only “minimally manipulated” in the process.
FDA approval is needed only if the stem cells are injected into another patient, or manipulated by being “expanded” – treated with human growth factor and induced to reproduce in labs before being injected.
McQuillan’s Aventura clinic and Bioheart Inc., a stem cell center in Sunrise, are sending U.S. patients to the Tijuana institute as subjects in research projects using fat and bone marrow stem cells to fight 22 diseases — congestive heart failure, critical limb ischemia (arterial blockage in the legs), emphysemia, retinitis pigmentosa (an eye condition that can lead to blindness), liver failure, type II diabetes, erectile dysfunction, frailty syndrome, renal failure, leukemia, MS, lupus, rheumatoid arthritis, MS, Parkinson’s, Alzheimer’s, stroke, cerebral palsy, autism, osteoarthritis, hip, knee and shoulder degeneration and post mastectomy breast reconstruction.
McQuillan and Kristin Comella, Bioheart’s chief scientific officer, are board members of the Tijuana institute. The research has been going on for about two years.
Most major U.S. research universities study only a handful of such projects at a time, doctors say.
Mexico has no equivalent of the FDA. Instead, research is done under the guidance of Hospital Angeles’ Institutional Review Board, with hospital specialists acting as principal investigators for each study.
The researchers keep Mexico’s Ministry of Health informed about what they are doing, but the ministry does not regulate the studies, Comella says.
“This is for people [from the U.S.] who have failed conservative treatments and who don’t have any more FDA-approved options,” says McQuillan. “We’ve had incredible results with chronic obstructive pulmonary disease (COPD) and congestive heart failure.”
She said they make it clear to patients that they are going for research, not everyday treatment.
So far, she adds, the institute in Mexico has only worked with “small numbers” of patients, so it can’t make any claims about how well the treatments work.
And this kind of research in the United States would require FDA approval, added Comella. Her husband, Shawn Man, is the basketball player who got the stem cell knee treatment in Aventura.
Other South Florida surgeons also are treating patients with their own stem cells for a variety of conditions, especially in orthopedics.
Purita, the Boca Raton orthopedic surgeon who injected New York Yankees pitcher Bartolo Colon’s shoulder with his own bone marrow and fat cells in 2009, and says he resurrected the player’s career.
Colon had ligament, tendon and rotator cuff damage. Purita harvested bone marrow from Colon’s hip, centrifuged it to isolate and concentrate the stem cells and reinjected them in the damaged shoulder. He did the same with fat from Colon’s waist.
Purita says that, since he took the stem cells from Colon and manipulated them only minimally, the process did not need FDA approval. He treated Colon in the Dominican Republic, the pitcher’s home, but says he routinely does the same therapy in his Boca Raton clinic.
Last year, the FDA filed an injunction against Broomfield, Colo., orthopedist Christopher Centeno for bone marrow stem cell injections to a patient’s knee. An FDA letter warning Centeno that he was violating FDA rules said: “These cells are considered drugs because the therapeutic claims shown on your website demonstrate that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.”
The FDA letter also complained that Centeno had manipulated the patient’s bone marrow stem cells by sending them to an outside lab where they were “isolated and then grown using growth factors from the patient blood before being inserted back into the patient.”
In August, Texas Gov. Rick Perry earned criticism from some U.S. stem cell experts for treating his aching back by having stem cells taken from his own fat, grown in a lab and injected into his back in an operation to fuse part of his spine, according to The Boston Globe.
Dr. George Daley of the Harvard Stem Cell Institute called it “poor judgment” and said it might “push desperate patients into the clinics of quacks,” the Globe said.
Says Purita: “What got Centeno in trouble was that he was manipulating the stem cells in an outside lab. That’s where problems can start. They [the cells] could grow too fast and get out of control and create tumors,” he says. “I don’t do that.”
McQuillan says she, too, avoids the techniques that got Centeno in trouble.
“My process doesn’t expand the stem cells. If I take your cells and give them back to you 70 minutes later, I don’t see the risk.”