Exclusive interview: Ambrosia getting back to business after FDA warning.
Research has demonstrated that giving old mice blood transfusions from younger mice shows signs of regenerating brain, muscle, and other tissues and boosting cognitive and physical performance. This has led to obvious questions around the procedure’s potential to combat the effects of aging in humans. [1]
Following the conclusion of a clinical trial in 2018, controversial start-up Ambrosia opened a clinic in San Francisco – offering infusions of young blood plasma from young donors to people aged 30 and older. According to the company’s web site, its trial found “statistically significant improvements in biomarkers related to Alzheimer’s disease, cancer, inflammation, and stem cells” after a single treatment.
“Young plasma, as found in our clinical trial, produces a number of objective improvements in blood tests,” Ambrosia’s founder and CEO, Jesse Karmazin told us. “The mechanistic details were identified in mouse studies, they are numerous and consistent.”
Last year, the US Food and Drug Administration issued a warning about plasma infusions, stating that they had “no proven clinical benefit” to the treatment of aging. Following the announcement in February 2019, Ambrosia stopped providing the procedure but its clinic was back up and running again just a few months later.
“The FDA did not research their announcement,” says Karmazin. “We were not contacted to provide data on safety or efficacy before it was published on February 19, 2019. According to the CDC, most patients who receive transfusions have no side effects.”
Following the announcement, Karmazin contacted both the FDA and his lawyers.
“The FDA’s announcement does not mention Ambrosia and it contains no requirements,” he adds. “The lawyers, who are experts in DC in the regulatory laws of medicine, unanimously told me our business is legal.”
According to Karmazin, Ambrosia has not raised any funding to date and is debt-free.
“Our business is operational and scalable,” he says. “I would welcome investment, but we are profitable treating patients currently.”
Whether Rolling Stones guitarist Keith Richards has been in touch with Ambrosia or not we decided not to ask, but the subject of using young blood to address aging is not going to go away. Transfusing patients with young blood is a very broad approach but companies like Alkahest and many research projects are also exploring blood plasma at a molecular level with a view to developing targeted approaches that may yield more specific treatments. [2]
The subject will be addressed later this month in a pre-conference workshop at the Longevity Therapeutics Summit in San Francisco.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5836258/
[2] https://www.pnas.org/content/116/25/12524
