Follistatin is a glycoprotein encoded by the FST gene. As for Minicircle, its most interesting property is its inhibition of myostatin, a protein that inhibits muscle growth. Lack of myostatin means muscle cells can regenerate and expand without routine biological testing. As a result, animals with this genetic mutation—like “bully” —equipped with cartoonishly inflated muscles. In theory, Follistatin gene therapy provides a quick way to achieve this muscle-strengthening effect.
Researchers have attempted to exploit this pathway to treat neuromuscular disorders associated with weak or underdeveloped muscles, such as ALS and muscular dystrophy. Scott Harper, principal investigator at the Center for Gene Therapy at National Children’s Hospital in Ohio, said: “To date, nothing has been shown to be effective in similar human clinical trials. as in animal models. Even so, Minicircle’s work to continue these efforts is not so unusual.
Where the plans are to pivot from the established literature and into territory closer to healthcare quack is the startup that aims to use follistatin gene therapy to boost muscle and strength. general well-being of healthy participants. Minicircle’s Mirror ad for the trial touts the therapy as an age-reversing and muscle-strengthening panacea — something little supported by the available evidence.
“Follistatin gene therapy increases muscle mass in animals. It doubles bone density and halves body fat, cardiovascular system improves rapidly, animals live longer and healthier lives,” Davis claims. In fact, his and his collaborators’ special human experiments with follistatin were the impetus to start Minicircle: “We’ve seen some very interesting effects,” he says.
But Harper says he hasn’t heard anything related to Minicircle’s more outlandish claim that follistatin gene therapy reduces chronic inflammation and body fat, enhances DNA repair and promotes age reversal. Robert Kotin, a gene therapy expert and professor of microbiology and physiological systems at the University of Massachusetts School of Medicine, agrees with Harper’s skepticism: “If I wanted to make one the antidote, I don’t think it’s follistatin. ”
Experts also criticized the company’s namesake minicircle technology. This approach involves a nonviral delivery method using a circular genetic structure—a “small circle”—to deliver genetic material into target cells.
But human studies using the minicircle technique to date have failed to deliver DNA into the cell nucleus in a clinically appropriate, safe and therapeutically appropriate way, said Mark Kay, a professor of genetics at the University of California. of Stanford, said (although he noted that the approach has had some success in vaccines). From what he learned on Minicircle’s website, Kay didn’t understand why this startup succeeded while others failed. “What is new in any of their technologies?” he asks. “How is it different?”
Minicircle’s approach differs from the main focus of the broader field of gene therapy: the use of viral vector technology, in which a neutralized virus carries new genetic material to target cells. However, Kotin notes that the viral vector method, like the one used by Minicircle, is simpler and cheaper to produce — and less likely to cause certain side effects, like deadly shock to the immune system. The company’s claims of reversibility seem to be based on the idea that small circles, unlike viruses, can be used over and over again, he said. (Of course, whether Minicircle’s treatments are effective—reversible or otherwise—has yet to be determined.)
