Droves of patients are heading overseas for stem-cell therapies unavailable in the U.S. Is it a dangerous scam or is America just behind the curve?
It’s 2:30 in the afternoon in the Dominican Republic, and Karen Velline, a 66-year-old grandmother from Cold Spring, Minnesota, is lying on an operating table, swaddled in sterile surgical sheets. She’s just moments away from a procedure so experimental that no doctor will perform it on U.S. soil. Yet she calmly stares up at the ceiling, more excited than anxious. Despite the controversy surrounding it, Velline believes that this procedure—which she has paid Regenocyte Therapeutic, a stem-cell company in Bonita Springs, Florida, $64,000 in cash to perform—could save her from a debilitating lung condition. After months of anticipation and planning, she’s ready for things to get under way.
Cardiologist Hector Rosario nods to his team and begins inserting a clear, narrow tube into a vein in Velline’s leg, slowly threading it all the way up to the right side of her heart. “That’s the catheter,” whispers medical supervisor Leonel Liriano, who has agreed to let me watch the surgery. I can see the tube moving on an x-ray imaging screen, inching closer to its final destination, the branched pulmonary arteries that supply blood to her lungs. With the catheter in place, Rosario reaches for a syringe filled with a solution of Velline’s own stem cells: the $64,000 potion. He inserts it into the catheter and depresses the plunger. A subsequent injection of saline serves as a chaser, ensuring that the cells migrate all the way to the lung vessels.
If the technique works as advertised, the cells—hand-couriered on a plane from Israel, where they were mixed with platelet growth factor to make them multiply, and delivered minutes ago to the operating room—will grow into the delicate gas-exchange regions of the lungs. Over several months, they should regenerate failing tissues that have been ravaged by Velline’s hypersensitivity pneumonitis, a degenerative lung disease caused by an allergic reaction to dust and chemicals that has left her dependent on three liters of oxygen a day. Doctors at the Mayo Clinic in Minnesota told her that the only hope of reversing her condition was a lung transplant, a high-risk procedure with a drawn-out recovery period. “That was something I didn’t want to consider,” she says.
Regenocyte presented an enticing alternative. Its glossy brochures and the effusive patient testimonials on its Web site offered hope that stem-cell therapy could not only keep her condition from getting worse but return her to her old self. If regenerative stem cells could help others, Velline reasoned, why couldn’t they help her too? As far as she was concerned, waiting years for the government to put its official seal of approval on the procedure wasn’t an option. She was dying.
Every year, hundreds of desperately ill Americans like Velline are making similar decisions, sidestepping government regulations and heading overseas to access a smorgasbord of stem-cell therapies unavailable in the U.S. Many of these treatments—offered by companies like Regenocyte, Germany’s XCell-Center and China’s Beike Biotechnology—involve autologous adult stem cells, meaning stem cells harvested from your own blood or bone marrow. These are thought to be safer than stem cells drawn from other donors or harvested from embryos, because they incur fewer risks of rejection or tumor formation. Just how safe, though, no one knows precisely, which is why the U.S. Food and Drug Administration insists on stringent regulations.
No comments:
Post a Comment