The announcement comes after the approval of the Institutional Review board, under FDA regulations an IRB is an appropriately constituted group that was formally designed to review and monitor biomedical research involving humans. Enrolling in this trial will cost a fee of one million to participate in this pay to play trial which only has five accepted subjects.
This trial is focussed on telomeres which are the protective end caps of chromosomes that are considered to be a measure of the human biological clock; each time a cell reproduces the telomeres gradually shorten until they become too short to function properly, once no longer functional the cell becomes inactive or senescent.
Dr. Jeff Mathis, president of the company says: “Traditional clinical trials in the US can take years and millions, or even billions, of dollars. The research and techniques that have been proven to work are ready now. We believe we have the scientist, the technology, the physicians, and the lab partners that are necessary to get this trial done faster and at a lower cost in Colombia.”
Those who sign up will need to pay their fees in their home country before they travel to Columbia to participate in the trial after signing the required consent forms. The trial aims to lengthen telomeres thereby treating aging. According to chief scientific officer Bill Andrew their approach has been observed to be safe, with minimal adverse reactions observed in 200 clinical trials.
Dr. Aubrey de Grey, Chief Science Officer and Co-founder of SENS Foundation commented: “Libella is the brainchild of Bill Andrews, who has been a very prominent and very legitimate scientist in the anti-aging world for a long, long time.”
“He’s very well-known and a very good scientist,” de Grey continued. “He’s got a particular angle about what kind of therapy he thinks is going to be useful and how useful, and as far as I’m concerned, more power to him. He 100% understands the vital importance of gathering as much data as possible from all of those patients, irrespective of whether that’s good or bad.”
This trial comes after a number of previous studies surrounding telomere functions in the aging process and the reproduction process for cancer cells. Recent research from the Spanish National Centre have also discovered a way to extend lifespan by extending telomeres in mice studies, and Stanford University School of Medicine also recently released a paper documenting an approach to temporarily lengthen telomeres.
This pay to play trial will be part of the growing body of evidence linking telomeres to the aging process. But it is worth noting there is still debate as to whether shortening telomeres is a direct cause of aging or a measure of the aging process.
The trial is expected to be completed in 2021, the results of this Phase 1 trial will no doubt be watched around the globe with much interest as this therapy is evaluated for safety and tolerability in the first five, million dollar, participants.
