This Medical Treatment Is Potentially Groundbreaking. So Why Isn’t It Available?

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Photo: Tetra Images

In the future, transfusions of aborted fetal stem cells might help those suffering from debilitating illness. But at the moment, it’s illegal for doctors to perform stem-cell therapy in the United States — though that doesn’t mean Americans aren’t already crossing the Mexican border to do it.

In a new documentary, The God Cells, director Eric Merola followed dozens of people who have conditions including Parkinson’s, multiple sclerosis, and muscular dystrophy as they sought intravenous fetal-stem-cell treatment in Tijuana. These people don’t want to wait around to see when, or if, there’s enough research for the government to approve the treatment.

Very broadly, a stem cell is a generalized cell that can become specialized as it matures. In embryos, stem cells divide and develop into different cell types, and in developed tissues they function as a repair system, replenishing and replacing worn out cells as they divide. (Fetal stem cells are considered superior to other types like embryonic, umbilical, and adult — more on that later.)

Because of these regenerative abilities, researchers have been looking into therapeutic uses of fetal stem cells for more than a decade, though under tight regulations and intense scrutiny. Before that, fetal tissue was used to create vaccines, including the ones for polio, rubella, chicken pox, and shingles. Even so, objections from pro-choice groups — and tepid research funding from the pharmaceutical industry that thrives off patented drugs — have prevented treatment from being widely available, despite the kind of stunning improvements documented in Merola’s film.

“I ended up going [to Mexico] about 12 times and honestly I was just kind of blown away,”  he said. “Most importantly, not everybody got better immediately or even later, but I saw enough to pique my interest.” A woman whose Parkinson’s resulted in severe hand tremors was able to play the piano again and a teen with cystic fibrosis improved his lung function enough that he could play basketball and play golf at altitude.

But not everyone fared as well, and Merola noticed that people who went for treatment sooner after diagnosis than later had better success. “I met countless Parkinson’s patients who’d had Parkinson’s for like 20 years and I stayed in touch with them and they didn’t really have any improvement. They had some things that got better, like maybe their eyesight, but it wasn’t what they were looking for.”

Merola also talked to some of their doctors, like the neurologist of man with MS who was “not enthusiastic” about his patient going to Mexico for an unproven treatment using fetal stem cells shipped from the country of Georgia. His warning: “If you’ve got the money to waste, go ahead!” Fetal stem cells don’t seem to harm anyone, at least physically: The treatments can cost anywhere between $10,000 to $35,000 out of pocket, making them limited to people who have a pile of cash or are really good at fundraising. After his patient was able to walk without his two canes, the doctor said: “I would never think that anything like this would work … I haven’t seen anyone get this well.”

There are four types of stem cells: embryonic, fetal, umbilical, and adult. Adult patients can sometimes use their own stem cells but the cells might suffer from DNA abnormalities from aging (like mutations and exposure to toxins) and they’re already tissue specific and can only make one or two types of cells. If people use donor adult cells, they need to be matched, just like bone marrow donors. Not only is umbilical-cord blood limited, it actually contains adult stem cells. Embryonic stem cells, from days-old embryos donated from leftover IVF cycles, can be difficult to direct into the kinds of cells needed and can turn into cancer cells. Fetal stem cells, on the other hand, are highly adaptable, divide rapidly, and are less likely to be rejected than adult ones.

Unsurprisingly, the use of both embryonic and fetal stem cells is controversial and pro-lifers morally oppose the practice. President George W. Bush instituted a ban on federally financed embryonic-stem-cell research that was only overturned by President Obama in 2009. At the time, White House officials said the change was meant to shield scientific decisions from political influence. The National Institutes of Health does fund fetal-stem-cell research but, in 2014, it spent $76 million in that area versus $166 million on embryonic-stem-cell research.

But that was before last summer, when the pro-life activist group Center for Medical Progress published attack videos that accused Planned Parenthood of profiting from the sale of aborted fetal tissue. You may remember seeing the hashtag #PPsellsbabyparts. Multiple state investigations found no wrongdoing; rather, Planned Parenthood was reimbursed for costs related to donation, which is completely legal. (It should be noted that only six of its clinics participate in donation programs.)

Proponents of fetal-tissue research argue that if women are going to have abortions, giving them the option to donate the tissue to science is akin to choosing to be an organ donor — both have the potential to improve the health or save the lives of others rather than having the tissue discarded. Even some people in the documentary who disagree with abortion personally had this view. As one woman said in the film, “If you’re going to have an abortion, don’t waste what could save someone’s life.”

But others think that discussing a societal benefit of abortion is a slippery slope. “What I hear all the time is the fear that women will intentionally get pregnant to have abortions to donate to science, and I just have a really hard time taking that seriously,” Merola says. “That’s just, wow.”

Meanwhile, some pro-life activists push hard for researcher to focus on adult stem cells rather than fetal ones. “Because they’re defending a way of thinking, they ignore science,” he says. “It just creates a big mess and the general public is so confused.”

“People in the industry have told me, way off the record, ‘It’s too bad, [fetal stem cells] are like the Ferarri versus the horse and carriage, but it’s just too controversial.’”

The U.S. Food and Drug Administration isn’t making things any easier. Merola attended the December 2015 science subcommittee board meeting of the California Institute for Regenerative Medicine, or CIRM, where its president explained that the amount of time it takes from discovering a stem-cell product that looks promising to getting FDA approval just to start clinical trials is six to eight years. The average for non-stem-cell treatments is 3.2 years.

Then there’s the resistance from the pharmaceutical industry, which relies heavily on patented drugs and funds more than half of the FDA’s budget for drug approvals. “Even if billions of dollars were spent on the clinical-trial process and randomized studies were done, you have to have it approved for each ailment type. So you have to go through 15 years just for, say, Parkinson’s. But then if you have multiple sclerosis, you’d have to fight to get it prescribed off-label. But before you even get that far, remember: Somebody has to spend the money and do the work.” And pharma companies can’t really patent cells that occur naturally.

But some regenerative-health companies are innovating around this problem. Stemedica, a company based in San Diego, treated hockey legend Gordie Howe after a stroke with a combination of adult stem cells from bone marrow and fetal neural tissue that had been replicated from a single source. The replication is a proprietary process. And, notably, Stemedica largely avoided controversy by referring to its fetal stem cells as “adult,” because they are technically more mature than embryonic ones.

All in all, Merola doesn’t believe fetal stem cells are a miracle cure, he just wants to further the discussion about their study and use.

“This isn’t like a magic bullet, I didn’t see this work for everyone,” he says. “I’m not going to defend it and pretend that this is proven and everybody should run out and get it. I was just hoping this would start a dialogue and open up people’s world to it. Maybe some scientists that see the merit or might want to look into it deeper and try to bring this to more people, that would be great.”

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