The first time he tried to recruit Tony Dorsett, Jackie Sherrill barely could get in the same room with him.
It was the early 1970s. Dorsett, a high school running back in Pennsylvania, was being courted by a swarm of college teams. But Sherrill, an assistant coach at Pittsburgh, soon gained the trust of Dorsett’s mother and signed him up, launching two legendary football careers, along with a friendship that has lasted a lifetime.
“Tony is kind of like my son,” Sherrill told USA TODAY Sports.
They still visit regularly even now, more than 40 years later, with Sherrill looking out for him to the point that he recently recruited him all over again, this time for something far more urgent.
After learning about Dorsett’s recent memory problems, Sherrill, 71, asked Dorsett, 61, to consider alternative medicine that might give both of them better lives after football. He invited Dorsett to try stem cell treatments that are not allowed in the USA — treatments they both received in Mexico last year and are planning to receive again this month.
The stem cells were extracted from their own stomach fat in Texas, before Celltex, a company in Houston, cultured and multiplied them with the help of a serum derived from cattle. The cells were then purified and injected back into them, about 200million at a time, in Cancun.
Dorsett, who played 12 NFL seasons, said he didn’t want to leave any stone unturned in the fight to slow his deteriorating condition, for which there is no cure. He has been diagnosed with symptoms of chronic traumatic encephalopathy (CTE), a brain disease linked to football head trauma.
“When I was taking the stem cells, I was able to figure things out a little better and not get as frustrated,” Dorsett told USA TODAY Sports. Likewise, Sherrill says the treatment dramatically helped his ailing knees and shoulder.
According to the U.S. Food and Drug Administration, the treatment they received is a biological drug because the cells were engineered beyond what nature intended for them. The FDA even intervened against Celltex in 2012, effectively shutting down the treatments in the USA unless the company could prove their safety and effectiveness through years of expensive clinical trials.
So now the company is shipping the cells to Mexico, where several former football players have received these treatments. Similar stem cell tourism has been on the rise, with several aging sports Hall of Famers, including NFL quarterback Bart Starr and hockey star Gordie Howe, trying various kinds of therapies in foreign countries. Many think they have run out of options in the USA.
“I’m determined to beat this, but it can be very frustrating at times, very frustrating to try to find places that I’ve been going to since I’ve been in the Dallas metroplex area,” said Dorsett, who starred for the Dallas Cowboys from 1977 to 1987. “All of a sudden you don’t know how to get there, and you’ve got to ask, ‘How do I get there?’ Thank God for GPS.”
Yet for all of their hype and potential, stem cell treatments are largely unproven by U.S. standards. The science behind it is still too young, leaving risks all around for patients and the companies trying to cash in on them.
People considering such foreign treatment “should understand they are taking a shot in the dark,” said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin. “There is nothing proven about what these guys are doing.”
Celltex thinks it has found an answer: growing huge populations of a person’s adult stem cells and banking them for future use. At the same time, the company’s short history shows how promise is mixed with pitfalls and uncertainty when trying to manipulate Mother Nature.
A Cure in Cancun?
Shortly after receiving stem cell treatments in Mexico last year, Sherrill noticed something strange happening to his body.
Normally, when working outdoors near his home in Texas, Sherrill would suffer minor cuts that wouldn’t heal for at least a few weeks. That changed after returning from Cancun.
“They were healing in two or three days, completely,” said Sherrill, who had coaching stints at Washington State, Pittsburgh, TexasA&M and Mississippi State. “That got my attention.”
Dorsett said he received an initial boost from the treatments. Since then, he said, the effect has faded, though Celltex CEO David Eller thinks that’s because he needs more regular injections. Treatments cost $4,000 or more, depending on the condition. The one-time fee for the initial extraction and storage is $6,500.
“I don’t know if it’s a psychological thing or what it is, but it didn’t have the staying power,” Dorsett said of the long-term effects of the treatments. “I felt good, but then, you know, it was gone. But I guess you’ve got to get so many million, zillion, trillion of your stem cells back in your body, and you do it over a period of time.”
Sherrill said his improvement was more lasting. After two national titles as a player at Alabama and a lifetime of coaching, his knees had hurt like crazy because of cartilage damage. And he could barely lift his shoulder because of a rotator cuff tear.
To avoid surgery, he considered Celltex, which he learned about after former Texas Gov. Rick Perry had boosted the company and become its first patient.
The process was simple. Sherrill and Dorsett first had fat extracted from their abdomens in Texas, where Celltex has a lab registered with the FDA to process, package and store the cells in the USA.
Because of the FDA’s intervention, they then traveled to a Cancun hospital twice to receive injections of the actual treatment. Sherrill said the pain soon went away in his knees.
“Within a week, I was doing everything with my shoulder that I did before,” Sherrill said.
Manipulation game
Eller formerly had been in the business of cloning cattle embryos to produce better beef. In 2011, he and Stanley Jones, a doctor, started Celltex, which initially paid $30 million to purchase its cellular technology from a South Korean firm that had been known for cloning dogs.
At Celltex, they use a bovine serum and other agents to help grow human cells before washing them and putting them back in the body. The reason for this, Eller said, is “to mimic the way your body’s own fluids cause cells to grow.”
It sounds like playing God to some degree. But it’s not, Eller said.
Rather, he says, it’s science using the human body’s own repair system to treat a range of diseases and ailments, including Parkinson’s, dementia and arthritis.
Like many U.S. clinics, Celltex extracts the stem cells from a patient’s own fat. But unlike U.S. clinics, it then cultures them and expands the cell populations, leading to its issues with the FDA.
Eller thinks anybody who gets stem cells will get some benefit. At U.S. clinics offering fat-derived stem cells, he said, patients might get 200,000 stem cells. With Celltex, the treatments can provide more than 200 million mesenchymal stem cells.
“More is better,” he said.
He explains it like this:
“When you were a kid and got a boo-boo on your arm and it turned red, that was stem cells rushing to heal that,” he said. “So that’s what happens anytime there is an injury.
“Stem cells will go there to help that. The problem generally is as you get older our stem cells stop producing as much as they did.”
Eller said about 800 patients had received the company’s treatment for a wide variety of health concerns. “No one’s had a problem about any of it,” Eller said of the patients. “It ranges anywhere from minimal improvement to miraculous improvement.”
Texas vs. the feds
Such claims, however, raise concerns. It sounds like a magic drug for a long list of unrelated conditions. It’s also not known if patients are healing naturally without any help from the treatment.
Leigh Turner, a bioethics expert at the University of Minnesota, became concerned about these issues after the company made headlines with Perry, a friend of Eller and Jones.
With Perry’s help, the company even had the backing of the state government in Texas, where about 230 patients received the treatment in 2011-12.
“I watched the company for a while and thought, ‘This is really pretty brazen; this can’t go on,'” Turner said. “‘If this is allowed to go on, really we’re talking about the complete breakdown of any kind of federal oversight.’
“You would be able start any kind of commercial enterprise you want and do what you want, and nobody does anything about it.”
So Turner sent a letter to the FDA about Celltex in 2012, questioning whether it was violating federal regulations designed to protect the public from unproven drugs that might not be safe or effective.
In general, the FDA has a critical threshold for adult stem cell therapies.
If the cells are more than minimally manipulated when extracted from a patient’s body, they are classified as biological drugs that must go through long and costly testing to make sure they are safe and effective for widespread use in the USA.
In this case, the FDA determined Celltex had exceeded this threshold, classifying its treatments as unapproved drugs.
“The role of the FDA is to make sure treatments and products are sold to Americans only when an independent authority has confirmed that they really are safe and they really are effective,” Charo said. “Why is the FDA doing this? Because that’s their job.”
Eller was miffed. He said his products were human cells from the same human patients, not drugs.
“I called Gov. Perry and told him he had me duct-taped to the front of a freight train” on a collision course with the federal government, Eller said.
The FDA’s decision caused him to take a detour to Mexico, where regulations about receiving these cells are not as strict. Meanwhile, he’s hoping to climb back aboard in a different way in the USA.
Eller says he’s working with American academic institutions to get clinical trials going in the USA for the Celltex product. Clinical studies have been underway in the USA to test the safety and efficacy of similar stem cell therapies from different organizations, possibly leading to American approval down the road.
Eller also said the company had plans for a University of Texas study involving Celltex cells and brain injuries.
“There’s so many former players out there that really need help,” said Sherrill, who hopes more data will lead to funding for more treatments for retired players.
Eller said multiple former players had received it but declined to identify them because he said he didn’t have their permission.
Like Dorsett, many of them want to leave no stone unturned in seeking a better quality of life. Besides spending $10,000 or more, they don’t see much risk in trying it or anything else like it.
“As far as seeing what I could do to slow this down, stop it, burst it, whatever, stem cells come from your own body, my own body,” Dorsett said. “It should work, but we’ll see.”
If the meantime, Dorsett has a request:
“Say a little prayer for me.”
By Brent Schrotenboer, Original article
This article was republished with permission from the original publisher, USA Today