Created on Feb. 1, 2013, 12:53 a.m. by Hevok
& updated by
on May 2, 2013, 5:03 p.m.
The system of clinical trials in Western countries has been bogged down by high costs, red tape, and governmental restrictions to the point that within 10 years the engine of innovation in biotechnology will die .
In order to prevent this and translate the discoveries made in the laboratory into treatments against Aging the following steps need to be undertaken:
Creating and IRB (institutional review board; patient protection committee) for such an clinical trial that would not have all the red tape and restrictions that currently prevent such novel strategies from being tested
Organizing a database of human volunteers who would be willing to participate in such a trial (without being paid) who also fully understand that they will be randomized and will know if they are being treated with the intervention or with the placebo. The clinical trial would be designed as a "cross-over-trial" so that each person does get the intervention during the first phase of the trial or during the cross-over 2nd phase of the trial. This way there will be always a control group for statistical validity, but at the some time enables also each person to be their own control (i.e. when they were on the placebo) as well as doubles the statistical power (placebo group is large and intervention group is large).
Finding a way to conduct the trial where each human volunteer administers the intervention themselves so that there is no large cost burden for doing the clinical trial (most clinical trails cost millions of dollars).
Finding a way to manufacture the intervention and the placebo in a territory where this would be legal.
Examples of possible intervention to test would be:
A prospect, randomized, combined Phase I and Phase II trial (i.e. the endpoints would be safety and efficacy in one trial) of a placebo vs olive oil vs. olive oil + C60 fullerenes
A prospective, randomized, combined Phase I and Phase II trial of a combination of rapamycin and metformin vs. rapamycin alone vs. rapamycin + metformin
A prospective, randomized, combined Phase I and Phase II trial of nano delivery systems for compounds that have been shown to have great clinical efficacy in vitro but very little efficacy in vivo, such as curcumin
A prospective, randomized combined Phase I and Phase II trial of liposome mediated gene silencing against various Gerontogenes (genes that promote Aging). This would first be started out conservatively with the Gerontogenes that were show to extend the lifespan greatly if suppressed (e.g. GHR).
Another approach that would be interesting for clinical trials is immunotherapy for senescent cell clearance by Natural Killer (NK) cells. While cellular Senescence vaccine would be have too many side effects (delayed wound healing), intermittent senescence cell clearance would be applicable.
Possible Diagnostics to be employed in order to assess the effectiveness of anti-Aging interventions shall ideally provide volunteers with a low cost way of:
Doing whole exosome sequencing early in life (young volunteers).
RNA sequence of gene activity before during the trial.
Doing epigenetic studies, such as DNA methylation, H3 and H4 modifications, chromatin organization, and microRNA Profiles with Aging.
Biomarkers panels that cost less than the $3,4000 Austin, Texas Biomarkers panel (250 biomarkers).
Full time measurement of easy accessible biometrics like circadian activity, blood sugar, and body temperature (e.g. with a watch like device).
This Project is not about creating a useless supplement or dangerous drug for commercial gain, but rather than to make clinical trails against Aging reality. The only ones who could volunteer for such a trial would be individuals that are fully educated about the fact that they are they are being guinea pigs and that this is a scientific experiment.
For this, it is time that the over 5,000 people who are members of the International Longevity Alliance (ILA) and associated to Denigma as well as various other groups (e.g. Caloric Restriction Society) interested in this subject, be given a method/vehicle to participate in a study that is designed as a clinical trial, conducted ethically and scientifically in such a way that the results would be publishable in a peer-reviewed journal. With volunteers and without the interface of the US FDA (who state that Aging is NOT a disease), a lot of work could be done that would start to prove what laboratory in vitro and in vivo Studies have already proven, but no government or company is willing to fund. There are already tools to do this. It just needs to be organized in a systematic way. It is unlikely that any government can block this.