A clinical trial that hopes to reverse ageing is charging participants $1million (£759,905) for the “elixir of youth”.
The Kansas-based pharmaceutical company Libella Gene Therapeutics is recruiting five healthy people over 45 to receive its gene therapy AAV-hTERT.
AAV-hTERT aims to lengthen a person’s telomeres, which “cap” the end of DNA strands. Longer telomeres have been linked to slower ageing, a longer lifespan and improved overall health.
Intravenously administering the gene TERT may trigger production of the telomere-producing enzyme telomerase, which could “prevent, delay or even reverse ageing”, Libella claims.
The trial has come under fire for its small size and steep entrance fee, particularly considering most clinical studies are free, with some even paying people to sign up.
People hoping to achieve “eternal youth” may be disappointed to learn the study is testing AAV-hTERT’s “safety and tolerability”, not efficacy.
Despite the criticism, Libella stands by its vision.
“I know what we’re trying to do sounds like science fiction, but I believe it’s a science reality,” Dr Jeff Mathis, CEO of Libella, told OneZero.
“The proof in the pudding will be to look in the mirror.”
Two people have reportedly been recruited, with the first - a 79-year-old - getting the one-off dose next month.
Libella is also recruiting for AAV-hTERT trials in five patients with Alzheimer’s and another five with critical limb ischemia, inadequate blood flow to the legs. This is despite limited evidence telomere length is involved in either condition.
Are telomeres linked to lifespan?
Scientists from the Spanish National Cancer Centre in Madrid found giving mice telomerase extended their lives by up to 24%.
Elizabeth Parrish, CEO of the “longevity company” BioViva, is thought to be the only person to have undergone “anti-ageing” gene therapy to date after receiving a treatment similar to AAV-hTERT in 2015.
BioViva reported the following year Ms Parrish’s telomeres were longer as a result, however, this was not published as part of a trial and no health benefits were mentioned.
Critics argue telomere length is not the only factor that influences ageing, with other genes and lifestyle habits also coming into play.
Administering telomerase may also cause cells to divide uncontrollably, leading to tumours.
Scientists from the University of Connecticut Health analysed the genes of more than 370,000 people for DNA that promotes longer telomeres.
These were associated with a 5% lower risk of heart disease but 11% higher odds of cancer.
The effect on ageing was determined by looking at the participants’ parents, with “little evidence for associations with parental lifespan or centenarian status”.
Libella’s TERT will reach cells via a “modified” virus, which cannot transmit infections. Some worry high doses of AAV- hTERT could still trigger an immune response. Libella has not stated the dose beyond saying it is “a lot”.
In further criticism, some question whether Libella launched the trial in Colombia to avoid US “red tape”.
“Even though the company is based in the United States, they’ve managed to find a way to evade US federal law by going to a jurisdiction where it’s easier to engage in this activity,” Leigh Turner, a bioethicist at the University of Minnesota, told OneZero.
Dr Mathis claimed Libella considered eight countries for the trial before landing on Colombia because it offered the “path of least resistance”.
“Traditional clinical trials in the US can take years and millions, or even billions, of dollars,” he said.
“We believe we have the scientists, the technology, the physicians and the lab partners necessary to get this done faster in Colombia,” Cision reported.
Bill Andrews - a molecular biologist behind the gene therapy - also justified the steep entrance fee, claiming it costs hundreds of thousands of dollars to treat one participant.
Although listed on the government-run website ClinicalTrials.gov, the US will not oversee the Colombian-based study.
Registering a trial on the website is reportedly relatively straight forward, with some calling it a “marketing platform” that gives an air of legitimacy.
Libella has been approached for comment.