On her Youtube channel, Dr. Nancy Alvarez can be seen talking about stem cell therapies.
“When I started getting that pain, I wanted to die,” she said on a video streamed on May 4, adding, “...I was able to control it because they injected me with stem cells.”
The popular sex therapist — who has made appearances on Spanish language television including our sister network Telemundo — and her husband Dr. Alvaro Skupin are now at the center of a lawsuit involving the use of stem cells.
The suit alleges Esperanza Cruz, 71, went blind after receiving stem cell therapy at the Mother Stem Institute in Coral Gables, which is owned by Alvarez.
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Skupin is a doctor at the clinic.
“They are desperate for hope. They are looking for help,” said attorney Andrew Yaffa, who is representing Cruz.
He told NBC 6 Cruz was seeking treatment for rheumatoid arthritis and the eye condition, macular degeneration.
Responding to every consumer complaint
The lawsuit alleges a stem cell product made of Cruz’s own blood and tissue was injected into her wrists and into her eyes.
“He injected not only the bad eye, he also injected the right eye, the good eye,” Yaffa said. “She is now blind in her good eye.”
This isn’t the first time NBC 6 Responds has reported about something like this happening.
In 2019, we told you about Doris Tyler, who said she went blind after having a similar procedure done at a different stem cell clinic in Georgia. Yaffa was also her attorney.
At the time, the U.S. Food and Drug Administration (FDA) estimated there were 700 clinics operating nationwide claiming to help dozens of ailments.
The agency said they were increasing their oversight of stem cell clinics, many of which were offering treatments not yet approved or proven to work.
More Clinics, Limited Oversight
For years, stem cells have offered huge hope for a number of conditions that currently have no cure. But as of now, the federal government has only approved stem cell products that consist of blood-forming stem cells that are derived from umbilical cord blood.
This hasn’t stopped thousands of for-profit clinics from opening across the country and advertising treatments that are not yet approved to be used.
“Is someone carefully monitoring what is going on at these facilities before a product is marketed? I think we can say the answer is no,” said University of California Professor Leigh Turner, Ph.D.
Turner is the Executive Director of the University of California, Irvine Bioethics Program. He has been tracking the spread of stem cell clinics since 2012.
His latest study found there were 2,754 clinics in 2021 across the country selling purported stem cell treatments. This is nearly five times more than in 2016.
“The people who are in this marketplace look around and realize that there are a lot of people speeding, but there aren’t many police cars out there and the odds of getting away with violating regulations are pretty high,” Turner said.
Stem cell products currently require FDA approval to be marketed to consumers. Before they are approved, these products require FDA oversight in a clinical trial.
Clinics were given three years to start following these guidelines. This grace period was set to expire in November 2020, but it was extended until May 2021.
Since 2019, the FDA has issued more than 350 “warning” letters and “untitled” letters to manufacturers, clinics, and health care providers noting they may be offering unapproved products and they need to follow FDA’s compliance and enforcement policy.
At least one Florida clinic has been barred from using certain stem cell products.
“There is an increase in regulatory activity but it is not slowing down the expansion of the marketplace,” Turner said.
In a statement, the FDA told NBC 6 Responds they “believe that most establishments share our goal of advancing the development of safe and effective regenerative medicine products to benefit individuals in need, there is no room for manufacturers, clinics, or health care practitioners to place patients at risk through products that violate the law.”
But when asked about their enforcement policy, they told NBC 6, as a matter of policy, “the FDA does not comment on its compliance or enforcement strategy regarding specific FDA-regulated products – or any potential enforcement actions it may or may not pursue through the United States Department of Justice.”
The Federal Trade Commission also can take action against businesses making illegal claims. In some states, state medical boards and the Attorney General's Office have stepped in.
We reached out to Dr. Nancy Alvarez and Dr. Alvaro Skupin but their attorney told NBC 6 that at this time, he has advised them not to make a comment about Cruz’s allegations and lawsuit.
In court documents, Dr. Skupin denies the allegation he injected Cruz’s eyes and Alvarez says her statements on her show about stem cell treatments helping her personally are not an “express warranty.” She goes on to say she didn’t sell or merchandise the products Cruz received.