When Jim Gass suffered a stroke in 2009, it soon was clear that standard rehabilitation would not repair the damage. Unwilling to accept life in a wheelchair, Gass decided his only option was to fly overseas for experimental stem cell treatment.
At clinics in Argentina, China, and Mexico, doctors injected Gass with what they described as stem cells from several sources, including fetal tissue, in attempts to reverse his partial paralysis. Clinics tout the treatments online as cutting edge and curative.
What happened to Gass next is a cautionary tale for other desperate patients seeking unproven and unregulated treatments in the murky world of “stem cell tourism,’’ warned a group of Brigham and Women’s Hospital doctors in a letter to the New England Journal of Medicine, published online Wednesday.
After scans showed something unfamiliar on Gass’s spine, where the latest round of stem cells had been injected, a Brigham doctor discovered a strange sticky fibrous growth there.
“It looked like nothing I had ever seen,’’ said Dr. John Chi, director of the neurosurgical spine cancer at the Brigham, who co-wrote the letter to the journal. “It was stuck onto the nerves and had an odd consistency.’’
Gass, 67, the former general counsel for Osram Sylvania in Wilmington, had chosen a particular clinic in Mexico in part because former San Francisco 49ers quarterback John Brodie had stroke treatment there that he considered successful.
But in the year after he returned from Mexico in September 2014, when he had his last treatment, he began experiencing extreme back pain and additional paralysis in his right leg, which had not been affected by the stroke, he said in an interview. That was what led him to the Brigham doctors for surgery last year.
Now Gass is more disabled than he was prior to stem cell therapy.
Brigham pathologists tested the tissue taken from Gass’s spine and determined it was a tumor-like growth but did not have mutations associated with cancer and therefore could not be treated with chemotherapy. Most of the cells were not Gass’s but from another source.
“It’s hard to know what to call it,’’ Chi said.
Doctors have treated Gass with radiation to shrink the mass, which has helped somewhat, but they are also searching for other solutions.
Doctors have been increasingly warning that stem cell clinics are proliferating around the world with little oversight. They are promoting their methods to patients suffering from strokes, amyotrophic lateral sclerosis (also known as Lou Gehrig’s disease), Alzheimer’s, and other conditions for which there are few good options. Professional athletes have helped popularize the clinics by seeking out stem cell therapy for strokes and shoulder and knee injuries.
Hockey legend Gordie Howe received experimental stem cell treatments in Tijuana, Mexico, in December 2014 — treatments that his family credited with helping prolong his life after a debilitating stroke about two months earlier. He died early this month at age 88.
Yet, bone marrow transplant, a treatment for leukemia, is the only approved stem cell therapy in the United States.
In the months after his stroke, Gass researched potential treatments constantly.
“I couldn’t accept where I was. A life lying down in bed is not the place to be,’’ he said. “The consensus was stem cell therapy was going to be the future of treatment for stroke. I read all the cautionary tales even though I didn’t believe them.
“I thought it would work,’’ he added.
Dr. Aaron Berkowitz, director of global neurology at the Brigham and the letter’s lead author, said it is hard to know how many people undergo unproven stem cell therapy.
A paper published in 2014 in the journal Travel Medicine and Infectious Disease identified 224 websites advertising stem cell clinics in 21 countries. They most often pushed treatments for multiple sclerosis, antiaging, Parkinson’s disease, stroke, and spinal cord injury — diseases and conditions for which there is no evidence that stem cell therapy is effective, though some are being studied.
In the United States, dozens of clinics have sprung up in recent years, largely avoiding regulation because they use cells extracted from a patient’s own body. But the US Food and Drug Administration signaled earlier this year that it planned to crack down on these clinics and issued draft guidelines explaining that even procedures using a patient’s own cells require approval by the agency.
Clinics overseas have more leeway and use stem cells from donors as well as fetal tissue.
“Even though there are probably hundreds of clinics in the US, when people go abroad the risk goes way up,’’ said Paul Knoepfler, a professor at the University of California Davis School of Medicine, who runs a popular stem cell research blog. “In Mexico you can treat someone with stem cells . . . and if you took the same procedure across the border, to do it legally, you’d have to get FDA approval.’’
Medical journals are increasingly writing about the phenomenon of stem cell tourism and have published reports of at least two other cases involving tumors, Berkowitz said.
“This is very risky,’’ he said. “It looks exciting that professional football players do it. But these are private clinics and they may be having a lot more complications that are not being disclosed. We don't know whether it’s working or not.’’
But some people may feel there is little other hope. As a result, the number of patients getting treatment outside the medical system is far higher than the number of patients enrolling in studies, Berkowitz said. Patients who might eventually get into experimental trials in a hospital don’t want to wait that long.
Gass, who is in the process of moving to San Diego, said his case is not only a warning to patients considering overseas treatment. He also hopes that discussing his experience publicly will light a fire under the federal government to quickly fund research into what could bea promising area of medicine.
For now, patients are relying on what they read online and athletes’ anecdotal accounts. Gass said he picked clinics that had positive or neutral reviews. But in some cases those testimonials came from doctors, speaking for patients. He did not want to name the clinics because he is worried they will sue him.
He tried several clinics because they each claimed to use slightly different approaches, he said. At the clinics, which operate like small private hospitals, doctors were careful not to promise positive results but said they expected Gass to show significant improvement. In Argentina, doctors said they injected him with his own stem cells. He did not getter better. He stayed three months in China, where physicians claimed to use fetal tissue cells.
“Every week they come by and tested you and the doctor says to his team ‘look how much better he is doing.’ I wasn’t doing better,’’ Gass said.
In the end, his body grew weaker after treatment and his wallet grew lighter. He estimates he spent $150,000 to $200,000 on the therapies alone. And while he lost most of the movement in his left arm and foot after the stroke, nerve damage from the tumor has left him with paralysis in his right leg, too.
“I still think it will work someday,’’ he said. “I just don’t know when.’’Liz Kowalczyk can be reached at firstname.lastname@example.org.