Burke County woman says stem cell clinic took money, hope in search for cure

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BURKE COUNTY, N.C. — Tammy Rivero carries around the oxygen tank keeping her alive, along with the memory of what was supposed to be a medical “miracle.”

“I can’t breathe,” Rivero said, in between coughs, on a cold day.

The 62-year-old can’t walk far without running out of breath

. She says she goes through eight tanks of oxygen a day. At her rural Burke County, N.C. home, she says, quietly, that she has only “a few months” to live.

“I’m passing away,” she said, crying. “And, I don’t want to die.”

Rivero suffers from Chronic Obstructive Pulmonary Disease and emphysema, incurable lung diseases, that make it difficult to breathe on her own or even be outside. She was excited when she saw an ad in 2015 offering stem cell treatments at the Lung Health Institute in Tampa, Fla., specifically aimed at helping lung diseases.

“They told me it would completely repair my lungs,” she recalled.

The FDA has touted stem cells as “one of the most promising new fields of science and medicine” that can one day potentially treat all sorts of diseases. For Rivero, seemed like a literal life-saver.

“Three-months to six-months is when they guaranteed I was going to be off oxygen,” she said.

The promise of a cure wasn’t cheap. Rivero, who lives on $800 a month in disability checks, says she had to pay $7500 “before” she could even “come into the office.”    

“I took a loan on my home,” she said. 

The Lung Institute “encouraged” her to take out a home equity loan to pay for her treatment, according to a lawsuit Rivero filed. She paid the money, went down to Florida and received treatment, which involved having her blood extracted, put through a centrifuge, and injected back into her body.

“Now that you have received your stem cell therapy,” Rivero’s medical record reads, “your body will begin an accelerated healing process.”

Hand-written notes show she was told she’d be “weaned off” oxygen and her lungs restored by as much as 94 percent.

“Did it work?,” asked FOX 46 investigative reporter Matt Grant.

“No,” said Rivero.

“Did it improve your life at all?” asked Grant. “Did it help your lungs?”

“Nope. Nope,” said Rivero. “It’s snake oil.”

Sitting at a small coffee table in a dimly lit room, Rivero looks over a stack of paperwork that document her quest for a cure, and the promise and peril of stem cell treatment.

“They put me through hell. I just hate people lying to me like this,” she said in tears.

In the United States, the Food and Drug Administration regulates stem cells. Currently, the FDA has only approved the use of umbilical cord blood to treat certain blood disorders. The FDA is now warning against unauthorized stem cell treatments, which it warns “can be harmful and may be illegal and unproven” to work.

The FDA has released a public campaign to warn patients and “unscrupulous” stem cell providers about a government crackdown next year. Agency officials are concerned unauthorized treatments can do real harm in addition to not being effective. Unapproved stem cell treatments have resulted in tumors, blindness, serious infections and death, according to the FDA.

“Have you seen ads or attended a seminar for stem cell therapies that claim to be able to treat diseases like chronic joint pain, Alzheimer’s, cancer and more?,” and FDA ad says. “Don’t believe it.”

Rivero and another patient are part of a proposed class action lawsuit. The attorney handling the case, Ben Vinson of Vinson Law in Tampa, says he represents “more than 40” former patients, or their representatives, who allege they too were duped by misleading medical claims.

The Lung Institute calls the lawsuit “meritless,” insists it is in compliance, denies Rivero’s allegations and argues in court records that patients consent to treatment.

“The Lung Health Institute has treated many thousands of patients for chronic lung disease,” a spokesperson said. “The vast majority of those patients reported positive outcomes after treatment as supported by established and accepted quality of life measures. This is a meritless lawsuit by two plaintiffs. We deny the allegations and intend to vigorously defend against all of the claims in the complaint, as outlined in the September 6, 2019 motion for summary judgment, to which plaintiffs have yet to respond.”

A judge is expected to rule on the class-action status next year.

“They’re giving them false hope,” said Rivero, who says she was told treatment would “heal” her “completely.”

Four years after her treatment, Rivero’s lungs are worse than ever. She now needs a double-lung transplant to survive. The pricetag is $7,000. It’s an amount, she says, she can’t afford to pay again.

“I think it’s just a scam. They’re ripping people off,” Rivero said. “They’re lying to patients that are desperate like me.”

If you are looking at stem cell therapy, even if the cells are your own, the FDA says you should first:

  • Ask if the FDA has reviewed the treatment
  • Request the Investigational New Drug Application, or IND, number, which is required for FDA-approved clinical trials.
  • Know that the FDA does not have oversight of treatments done in other countries.

 Read the FDA warning about stem cells here

Read FDA Commissioner Scott Gottlieb’s announcement on “increased enforcement” here

Read about Rivero’s need for a double-lung transplant here

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