When three elderly women with a common age-related eye disease were blinded after receiving stem cell injections at a Broward County clinic in summer 2015, the red flags were apparent to Thomas Albini, a clinical ophthalmologist with the University of Miami Health System’s Bascom Palmer Eye Institute.
Raising Albini’s suspicion were the women’s accounts of what had happened: Each had both eyes injected on the same day with stem cells extracted from their body fat. They received little to no follow-up care or evaluation before or after the treatments. And they paid $5,000 each for the procedure.
“When that all was revealed, I was just in disbelief that this was happening in Broward,” said Albini, who helped care for two of the three women and co-wrote an article in this week’s New England Journal of Medicine detailing his experience.
“I knew that things like this could happen in other countries that don’t have a sophisticated medical regulatory environment,” Albini said Thursday. “But I really was naive to the fact that this could happen in the United States. Then I realized I was just as naive about it as the patients were.”
The CEO of the publicly traded company for which the Sunrise clinic is named and where the women received the stem cell injections said he believes the article was intended to hurt the company’s finances.
Albini’s article, which was co-written with nine other physicians, exposes what he calls a “loophole” in the U.S. government’s oversight of unproven treatments involving stem cells. It also raises questions about whether federal regulators are doing enough to protect patients from risky medical procedures — especially ones that project the false impression that they are government approved.
He said he co-wrote the article to alert physicians and patients to the dangers of unwarranted claims about the healing power of stem cells, which Albini said hold great promise but remain largely untested for clinical use.
“For us to get to the point where we can establish good stem cell therapy,” he said, “we have to do good research that is ethical and also scientific. Whatever these patients had, it was neither ethical or scientific.”
In a written statement issued Thursday, Mike Tomás, CEO of U.S. Stem Cell, a biotech company that Tomás said has a minority interest in the clinic, called the NEJM article “old news” and suggested it had been published to challenge the company’s most recent financial report that revenue had risen by 38 percent, from $2.2 million in 2015 to $3.03 million in 2016. Tomás’s statement was issued in response to a Miami Herald request for comment made to the clinic, U.S. Stem Cell Clinic.
Tomás, who is a judge for the Miami Herald’s annual Business Plan Challenge, also pushed back on suggestions that the clinic’s stem cell treatments are unsafe.
“For nearly 20 years our clinics have conducted more than 7,000 stem cell procedures with less than 0.01 percent adverse reactions reported,” he said in the written statement. Tomás declined to comment on the patients, citing federal privacy rules. But he added that the clinic no longer offers eye treatments.
The three women, ages 72, 78 and 88, all had macular degeneration, a common eye disease among the elderly that can lead to vision loss. They received the stem cell injections at a clinic in Sunrise that incorporated in 2014 as Regenestem Health and that same year changed its name to U.S. Stem Cell Clinic.
Within 36 hours of their treatment at the Broward clinic, two of the three women went to the emergency room at Bascom Palmer for blinding conditions, including increased blood pressure in their eyes, excessive bleeding, retinal detachment and dislocation of their lens.
Although the women had moderate vision loss prior to the stem cell treatments, a year later their vision ranged from total blindness to 20/200, which is considered legally blind.
“The thing that was most alarming when I saw these patients come to Bascom Palmer was the fact that they had this procedure done on both eyes in the same day,” Albini said. “If you’re going to do something experimental, God gave us two eyes. Do it in one eye at a time. Even commonplace surgeries like cataracts are not performed on both eyes on the same day.”
Albini spoke to two of the women and believes they might have been misled into thinking that they were participating in a legitimate clinical trial sanctioned by the National Institutes of Health, part of the U.S. Department of Health and Human Services, because at least two of the women said they learned about the stem cell procedure through the website ClinicalTrials.gov — an NIH database that lists publicly and privately supported clinical studies conducted around the world.
“They think that when they see that, that it’s a rubber stamp of approval from the United States government and somebody has investigated this and said this is a legitimate therapy,” he said. “What became quickly apparent to me was that it wasn’t clear they had participated in any sort of clinical trial. It didn’t sound like a trial in terms of any of the follow up or the evaluation.”
Congress established ClinicalTrials.gov for many reasons, including to provide information about publicly and privately sponsored clinical studies, said Renate Myles, an NIH spokeswoman, in a written statement.
The information on the website is provided by study sponsors or principal investigators, but posting on ClinicalTrials.gov does not necessarily reflect endorsement by the NIH, Myles said.
“ClinicalTrials.gov does not independently verify the scientific validity or relevance of the trial itself beyond a limited quality control review,” she said in the statement. Myles urged patients to talk to their doctors before participating in a study and she noted that the NIH has now posted a more prominent disclaimer on the website.
For-profit clinics offering unproven stem cell treatments and making unsubstantiated claims to about their ability to cure a range of medical disorders have proliferated in the United States after first gaining popularity overseas, said Timothy Caufield, a professor of health law and science policy at the University of Alberta in Canada.
Many have evaded regulation by the Food and Drug Administration in part because they use stem cells extracted from a patient’s own body and because they don’t manipulate those cells too much before re-injecting them — a process considered a medical procedure and not a drug.
“Some of these clinics are making promises about therapies for ALS, for cancer, for autism, for everything,” Caufield said, “and of course more for cosmetic procedures, like anti-wrinkle, anti-aging.”
But, Caufield said, there are very few stem cell therapies approved for clinical use, and that regulation is not preventing the science from advancing. He urged patients to consult the International Society for Stem Cell Research’s patient handbook before considering stem cell therapies.
“There’s this perception that there are all these stem cell therapies out there that are close to clinical application that ... are being held back by regulators and if they just step back, there would be all these treatments,” he said. “It’s just not the case. The science isn’t there yet.”