FDA to increase enforcement against unauthorized stem cell clinics

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HILDEBRAN, N.C. — Tammy Rivero says the promise of a stem cell miracle cure has drained her – out of thousands of dollars and any hope she had left.

“They guaranteed I was going to be off oxygen,” said Rivero, 62, after paying $7,500 for stem cell treatments to heal her incurable lung disease. Since she is on eight tanks of oxygen a day, she thought this treatment would be a life-saver.

“I felt excited,” said Rivero. “It was my miracle cure.”

Four years later, Rivero’s lungs are worse than ever. The treatment didn’t result in an “accelerated healing process,” as she was promised. She now needs a double-lung transplant to survive.

“They put me through hell,” she said, crying.

BURKE COUNTY WOMAN SAYS STEM CELL CLINIC TOOK MONEY, HOPE IN SEARCH FOR CURE

Many stem cell treatments on the market today are not legal, according to the Food and Drug Administration, which regulates stem cells in the US. The agency is now warning patients about “deceptive and sometimes corrupt assurances” that are based on “unproven and in some cases dangerously dubious products.”

The FDA warns it will “increase enforcement” and begin cracking down on unauthorized stem cell clinics next year.

Currently, the FDA has only authorized stem cells to treat certain blood disorders. Officials say stem cell treatments that are not FDA-approved or part of an Investigation New Drug Application (IND) clinical trial can be illegal, potentially harmful and unproven to work.

If a stem cell clinic says it is “registered with the FDA,” that does not necessarily mean it has approval from the FDA to use stem cell treatments.

Despite that, a FOX 46 investigation found a number of stem cell clinics across the Carolinas making questionable claims that stem cells will cure everything from chronic pain to erectile dysfunction.

“We’re using pre-screened cells from verified candidates,” a salesperson told a North Carolina patient in a secretly recorded call that was provided to FOX 46. “You’re basically, like, getting a bigger penis that’s capable of more firm erections.”

FOX 46 asked Duke University physician Dr. Joanne Kurtzberg about the claims.

“I think it’s dangerous and misleading,” said Kurtzberg.

Kurtzberg is the director of the Marcus Center for Cellular Cures, a world-renowned stem cell research lab at Duke’s School of Medicine in Durham.

“The majority of these clinics are setting up shop without the appropriate regulatory authority or approvals,” she said. “And I worry that they will do damage to the promising evolving fields of regenerative medicine and cell therapy.”

Kurtzberg worries unauthorized clinics won’t collect data on patient side effects, which the FDA requires in clinical trials, or screen cells to ensure they are free from disease.

“I think people doing legitimate research in these areas understand the desperation patients feel and their huge desire to have access to these therapies,” said Kurtzberg. “And I think, sometimes, the thinking they have is, ‘Well, it can’t hurt me so why not try it?’ And I think people need to know that’s not known. These therapies are not all proven to be safe.”

She thinks it will be “several more years” before these products are able to be FDA-approved.

North Carolina Attorney General Josh Stein says for all the incredible promises stem cells hold, patients need to be cautious and wary of hyped-up claims.

“The FDA has approved very little stem cell work,” said Stein. “So, if you are being pitched some stem cell magical elixir that’s going to save your life, contact the FDA to make sure it’s a legitimate offering.”

“It not only may be useless to you,” he added, “it may harm you.”

The FDA has received reports of tumors, blindness, serious infections and even death linked to unauthorized stem cell treatments.

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.”

Rivero hopes her story serves as a warning to others.

“I just want people to know don’t waste your money on stem cells,” she said, with tears in her eyes. “Especially, for the lungs. Because, you just, you need to get other options.”

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 by clicking here

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

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

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