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Behind The Scenes In The Stem Cell Industry

It wasn't just that William Caulkins could barely walk, it was that he could barely do anything. Waking up in the morning, getting up out of a chair, doing absolutely anything for himself became a struggle to just merely catch a breath.

At 67 years old, Caulkins figured his chronic lung disease was days away from killing him. Soon, he'd attempt to take in a breath and no air would come, ever again.

A year into doctor's visits and bleaker and bleaker prognoses, a friend told Caulkins about something totally, absolutely risky. He signed up that day.

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“That was my last chance. That's it. I was hospitalized four times in six months, and I knew that was going to be it,” Caulkins says.

Caulkins' wife drove him all day from their home in Nassau County, north of Jacksonville. When they arrived at a stem cell clinic in Broward County, Caulkins could barely make it to the door, his oxygen tank dragging behind him.

Scripps Research laboratories
At the Scripps Research laboratories in Jupiter, stem cells treated with fluorescent dye are illuminated in a photo taken through a microscope.

At U.S. Stem Cell Clinic, they inserted a needle into Caulkins' fat cells. They extracted stem cells, treated them and then inserted them back into his body.

He noticed the difference almost right away, during the long drive home. By the next morning, he was taking deep, life-changing breaths, for the first time in months. Days later, he gave up the oxygen tank. He could walk again, he could complete a sentence without getting winded in the middle, and it seemed like he had been given life.

“I took a chance, and it worked. I was amazed,” Caulkins says.

It would be nice if we could say the experience Caulkins had with stem cells is shared by all of the patients at South Florida's stem cell clinics. But the largely unregulated and mostly untested field of treating patients with stem cells has vastly varying results, with lawsuits and threats from government regulators to shut the entire industry down.

Meanwhile, South Florida has perhaps more stem cell clinics than any other region in the nation— a cottage industry built on promises of cures to everything from chronic pain to eye disease.



And yet, despite a government crackdown and lawsuits against stem cell clinics, there are countless tales of the kind of success Caulkins had. Study after study has backed up some of the claims about stem cells. For patients suffering from diseases and injuries that haven't been cured by other means, many say it's worth taking the risk on stem cells.

While stem cells have become widely known in the past decade, their discovery dates back to 1908, when a Russian histologist discovered a cell that seemed be the precursor to every other cell. Think of stem cells like the simple two-by-four framing of a home—before adding the rest of the construction materials, the house could become craftsman or Victorian or a thousand other styles. Similarly, the body can convert stem cells into multiple types of cells, growing tissue and repairing damaged areas of the body.

Doctors for the past half-century have been injecting patients with stem cells to try to treat diseases. Clinics across South Florida make wide-ranging claims about how stem cells can be used, including for treatments for Alzheimer's and multiple sclerosis. The treatments aren't covered by insurance, and so patients are asked to shell out thousands out of pocket for the injections. Like most of the websites for stem cell clinics, the page for Back in Action Medical Center in Stuart, for instance, says the clinic offers “innovative stem cell injection therapy” to help with knee pain, arthritis, tissue regrowth, degenerative disc disease, headaches and others.

Michelle Parlo
Michelle Parlo, a physician assistant and clinic director at U.S. Stem Cell

Michelle Parlo, a physician assistant and clinic director at U.S. Stem Cell, says her clinic has treated thousands of patients since it began in 2001. It now has three locations, in Weston, The Villages and West Palm Beach.

“We treat anything and everything,” she says.

Since she started at the clinic in 2014, she says she has watched patients who could barely walk when they came in jaunt their way out the front door afterward. Parlo claims her clinic has conducted studies that show their treatments are often 99 percent effective.

Like most of the South Florida stem cell clinics, U.S. Stem Cell uses a procedure where they remove stem cells from fat cells and then “separate them from toxins,” Parlo says. When inserted back in the body, she says the stem cells can regrow tissue, replace diseased cells and cure people of potentially fatal diseases.

“These are your cells, in your body, doing exactly what they're supposed to do,” Parlo says.

In April 2017, investigators from the Food and Drug Administration began a monthlong investigation into U.S. Stem Cell's work. They determined the clinic's stem cell procedure wasn't allowed under federal law, because injecting the harvested stem cells back into someone constituted a drug that would need FDA approval.

The FDA claims its investigation found records of multiple adverse effects from the treatments. Among them was a patient who was treated on June 16, 2016, for macular degeneration and later had to be taken to the emergency room, where it was discovered she was suffering hemorrhages and ocular hypertension. The FDA says it found records of two other patients treated for macular degeneration who then suffered complete vision loss.

Those types of cautionary tales are not rare. Jeannine Mallard in June 2018 told CBS 4 Miami that she flew from her home in France to South Florida in 2015 for a series of stem cell treatments at the Hollywood Eye Institute in Cooper City. Afterward, Mallard says her eye began to swell and then shrink, and since then, not only has she lost vision, but her eye has become shrunken and deformed. The Hollywood Eye Institute did not return phone messages seeking a response.

In November 2017, the FDA issued guidelines asserting its authority over stem cell clinics and threatened a wide crackdown. The FDA also sent a warning letter to U.S. Stem Cell asking the clinic to cease treatments. When the letter was ignored, the U.S. Attorney's Office filed a lawsuit in May 2018 that seeks to have a federal judge shut down the practice. The U.S. Attorney's Office declined to comment on the lawsuit, but the complaint states: “There are not now, nor have there ever been any approved new drug application” to cover stem cell treatments.

The lawsuit names only U.S. Stem Cell and its owners, but it indicates a wider shot across the bow against South Florida's stem cell industry. More than 100 clinics now operate in Florida, most of them based between Miami and Stuart. If a judge were to rule against U.S. Stem Cell, many of them would likely shutter or face similar government lawsuits.

But Parlo says her clinic has no intention of backing down and will fight the lawsuit and the clinic's right to continue. She says injecting someone with their own stem cells shouldn't be defined as a drug treatment. Taking other tissue from the body, like in a skin graft, isn't regulated by the FDA, and so neither should stem cells, she says.

“God forbid the FDA shuts us down, because I could never go back to practicing traditional medicine,” Parlo says. “In the future, physicians should be trained in this.” As of now, stem cell treatments aren't covered at medical school and are rarely discussed in traditional doctor's offices, she says.

Dr. Donald Phinney
Dr. Donald Phinney of Scripps Research in Jupiter Photo by Scott Wiseman

That could change if Dr. Donald Phinney is able to finish his work at the Scripps Research Institute in Jupiter. In August, Phinney won a $2.9 million grant to develop a method that could perfect stem cell treatments and help define exactly what kind of diseases can be cured with stem cells.

Phinney says his work shows that not all stem cells are equal. Extract them from one part of the body or another and you're likely to get entirely different properties that allow the stem cells to do different things. Some stem cells from certain parts of the body are effective as immunosuppressants, which could help transplant patients from rejecting new organs. Others are better at stopping inflammation, which could help treat arthritis and lupus. Take stem cells from the right part of the body and they may help people with non-healing wounds, especially for those suffering from Crohn's disease.

Coming up with a series of metrics to determine how and where stem cells should be harvested is the first step in Phinney's research. Trials of the metrics then may determine which stem cells are effective in treating certain diseases.

As of now, most stem cells are harvested with little regard for how effective they will be with certain diseases. “In most manufacturing processes, the goal is to make lots of stem cells, but we need to be more selective,” Phinney says.

He's far from alone in researching ways to improve stem cell treatments. Dr. Marilyn K. Glassberg, professor of medicine, surgery and pediatrics at the University of Miami, has published results of a study in which she was able to use stem cells to treat patients suffering from lung disease, a finding so significant that she presented her findings in July 2018 at the Vatican during an international health conference.

Dr. Joshua Hare, director of the University of Miami's Interdisciplinary Stem Cell Institute, announced in October 2017 that his team had found what may be a stem cell treatment for frailty, which causes some older people to become weak. In a clinical trial, elderly patients treated with stem cells could walk longer distances and breathe easier after a single dose of stem cells.

Their work could influence the stem cell industry in South Florida, perhaps improving the way stem cells are harvested and narrowing the promises made about cures.

Until then, Parlo says stem cell clinics should continue to treat patients and ignore the government's attempts to shut them down. Asked about the lawsuit her clinic faces, Parlo says: “It's ridiculous, it's immoral and there's no constitutional reason they're doing this.”

In March, the FDA's lawsuit was headed for court-ordered mediation, but Parlo says her clinic wouldn't be willing to accept any settlement that would forbid them from continuing their work.

As the lawsuit played out, Caulkins says he will be heading back to U.S. Stem Cell for his second and perhaps final treatment. He has been telling friends about it and at least a couple are planning to try it themselves. Spending the $6,000 on the treatment isn't easy for Caulkins, a retired surveyor, but he says the treatment may have saved his life.

“Nobody told me to say this,” Caulkins says. “I'm speaking for me, not anybody else.”

Scripps Research laboratories
Bone-marrow-based stem cells, suspended in a culture solution and labeled by subtype, are ready for the day's experiments at the Scripps Research laboratories in Jupiter. Photo by Scott Wiseman