#chelation

Ed Pilkington at The Guardian:

Landyn Holdren is an eight-year-old autistic child who has high support needs and is nonspeaking. His mother, Christy Holdren, says he can be self-harming, slapping his chest, face or head when distressed. Later this month, she will spend $15,000 on an unapproved stem cell treatment she hopes might help him.

They went for the first round of the treatment last October at a Florida stem cell clinic that charged Holdren $12,500. The procedure is not approved by the Food and Drug Administration (FDA), and scientists say there is little evidence it works for autism, raising concerns that desperate families are being sold false hope.

Yet as stem cell clinics multiply across America, they are finding an influential ally in the US health secretary, Robert F Kennedy Jr. Holdren knows there is no “cure” for autism, which is a condition, not a disease. But she said she was determined to do her utmost to help her child. “He actually looks at us and not through us, and that’s huge for us,” she said of the small but significant changes she believes followed Landyn’s first infusion. “We can cut his hair without him freaking out. That may sound little, but when you have to wrangle an alligator to clip his nails, that’s big things.” Seven months on, Landyn’s aggressive and self-harming behaviour is worsening again. So, despite the cost that has driven Holdren to take out a loan against her retirement savings, she is preparing to return for a second stem cell dose.

A ‘completely bogus’ treatment

The Holdrens are far from alone. Across the US, children with autism as young as 18 months old are being given unapproved stem cell treatments at clinics in Florida, Texas and elsewhere, part of a growing market operating beyond the bounds of FDA approval. The procedure often involves the child being sedated before receiving intravenous doses of millions of stem cells commonly derived from human umbilical cords harvested at birth. In some cases, the doctors selling the treatments have no scientific expertise in autism or child development. Instead, physicians from unrelated specialties, including plastic surgery and orthopaedics, have entered the booming stem cell sector, billing the procedures as “regenerative medicine” for children, some of whom have severe disabilities. Up to now, Americans seeking therapies that lack federal approval have tended to look abroad. That has fed the flourishing multibillion-dollar industry of “stem cell tourism” in places such as Mexico and Panama – and as far afield as Abu Dhabi.

Now the practice appears to be gaining strength inside the US, and there are fears that under Kennedy’s leadership, the FDA may be loosening its rigorous regulation. Paul Knoepfler, a stem cell biologist at the UC Davis School of Medicine who acts as an unofficial watchdog of stem cell clinics through his blog, the Niche, has detected a slump in enforcement activity under Kennedy. He is concerned that the pattern will harden into a change of government policy.

“We haven’t seen the FDA taking action in the last 18 months. I think we’re going to see big change coming from the FDA very soon, backing off oversight of birth-related stem cells,” he said. Arnold Kriegstein, professor of neurology at the University of California San Francisco who led its stem cell research for almost two decades until 2022, said that concern was growing about the spread of expensive and medically unproven interventions on highly vulnerable children. “I’m appalled that this is being allowed to go on in the US, and that so many desperate people are being taken advantage of with a ‘treatment’ that in my view is completely bogus.” The FDA has so far only approved stem cells for use in a very narrow range of cases, such as bone marrow transplants or to boost a cancer patient’s immune system after chemotherapy using their own, their siblings’ or unrelated donors’ matching stem cells. But the technique is attracting mounting attention for use in a range of treatments. Stem cells are the body’s master cells, from which all other cells derive. They can renew themselves, develop into specialised cells and heal after injury.

[...]

The Tijuana experiment

For years, advocates of fringe autism treatments largely operated on the margins of US medicine. Under Kennedy, some are now gaining unprecedented influence with the federal government. In January, Kennedy appointed Tracy Slepcevic, the mother of an autistic child and a vocal supporter of alternative therapies, to a federal committee that helps steer national autism research policy. She was one of 21 new appointees who were elevated to the panel after Kennedy dismissed all its previous members. Several of the new advisers, Slepcevic included, share the health secretary’s skepticism toward vaccines.

Slepcevic describes in her book, Warrior Mom, how she arranged for her child to undergo several unproven treatments including high-dose vitamin C, hyperbaric oxygen chambers, intravenous ozone and chelation therapy, a technique to remove heavy metals from the body. The FDA has warned that chelation can cause serious and possibly fatal side-effects such as kidney failure.

Slepcevic also took her son to Ukraine for stem cell therapy following a protocol set by Jeff Bradstreet, a controversial anti-vaccine doctor. (Bradstreet died in an apparent suicide in 2015 shortly after his wellness center in Buford, Georgia, was raided by the FBI in an investigation into “frauds and swindles”.) In April, Slepcevic, who is also a leader of the California chapter of Children’s Health Defense, the anti-vaccination group that Kennedy chaired until 2023, staged an Autism Health Summit in San Diego for the second year running.

The star speaker, beamed in on video, was Kennedy. The health secretary described Slepcevic and her husband, Steve, as his “good friends”. He promised attenders that he planned to “create opportunities that extend across a lifetime”, and exhorted his audience to “work with us to drive solutions together”. Slepcevic did not respond to a Guardian request for comment. It was at the summit that Slepcevic announced a “pioneering” new experiment that she has initiated in partnership with a clinic in Tijuana, Mexico. Given its location, the center operates outside the FDA’s stringent controls, falling under the remit of the Mexican regulator Cofepris. The Tijuana experiment, which is being billed as a “clinical trial” under Mexican oversight, will begin on 15 July. It will involve umbilical stem cells being given to a target group of 120 boys and girls aged seven to 15 who have an official autism diagnosis ranging from mild to severe.

Gadolinium, element 64, has been used in Magnetic Resonance Imaging (MRI) for some time as a contrast agent (to make it easier to see certain details in several organs) and, it turns out, depending on the chelating agent it can be left behind in varying amounts in those tissues. Amounts that may be toxic and in 0.03-1% of people may cause Anaphylactoid reactions and possibly Gadolinium metallosis. That later is what is being mentioned in the article. A short abstract of the study is available at the National Institute of Health.