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More Trials and Cost Effective Trials of Rejuvenation Therapies are Much Needed


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#1 reason

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Posted 22 October 2021 - 10:22 AM


It costs a great deal to run a reasonably sized clinical trial within the formal system of regulatory governance. If the goal is to make a compelling demonstration of effectiveness, then at the very least a larger-than-usual phase 2 trial is required. The cost of getting to that point is upwards of $15-20 million in industry, and still a substantial fraction of that for academic institutions that have much of the supporting infrastructure already in place. Yet groups like Lifespan.io can put together a less formally administered trial, one that will teach us almost as much about whether or not a given approach is efficacious, for less than $250,000.

Not enough of this sort of work is taking place. There are too few low-cost assessments carried out with the aim of generating good data that may otherwise never arise. Even just looking at senolytics, there are scores of age-related conditions that may be beneficially effected by the low-cost dasatinib and quercetin combination. Academia and industry have yet to even start on the assessment of senolytic treaments for more than three of four of those indications. Time is ticking. The world needs more organizations and collaborative projects like Lifespan.io and the RLE Group noted here, working to responsibly gather data to show whether the present range of promising approaches to the treatment of aging work or not.

Our another achievement is the plasmapheresis trial, which is pretty well-known in the community. We didn't expect to observe dramatic improvements in biomarkers that we would treat as promising, we just wanted to understand the logistics of the whole plasmapheresis process. Because you need to replace half of your plasma with the saline + albumin solution and this is not a simple and standard procedure. But we managed to calculate how many plasma you need to donate with each visit to the doctor and how many albumin you need to replace and we did this and surprisingly we have found some pretty interesting changes in the biomarkers of this gentleman. We have found, for instance and contrary to our expectations, that cholesterol goes both directions - bad LDL goes down and good HDL goes up, which is pretty interesting. Of course we have only two data points, so we cannot draw too many conclusions from that, but we have started a clinical trial aiming to compare plasmapheresis with albumin and without albumin, because the role of albumin of the whole procedure is an interesting question.

A few smaller things our group has achieved. We have tried various senolytics in our volunteers. Created a lentiviral vector for APO-A1 Milano gene delivery. And also a microbiome replacement experiment, because we have access to samples from soviet cosmonauts (who are usually considered exceptionally healthy, so our hypothesis is that transferring the microbiome could yield interesting health improvements).

Here are several things we are planning to deliver in the upcoming years. We are intrigued by the study showing muscular aging through 15-PGDH, and we want to reproduce it on ourselves. Another target is epigenetic rejuvenation of hematopoietic stem cell function via targeting Cdc42. This type of cell is very reluctant to different approaches in reversing aging (even our extracellular matrix one), so we plan to rejuvenate them and investigate how to maintain the useful environment for these rejuvenated cells. The third thing is targeting elastogenesis. Elastin is now considered to be one of the longest living proteins in our body, elastogenesis is limited to early infancy and then the old synthesized elastin remains in our body, accumulates calcium, is degraded by enzymes and so on, therefore we lose elastin which leads to progressive deterioration of various tissues - blood vessels, skin, lungs, ligaments, muscles, ... All tissues lose their elasticity and that is crucial not only for appearance but also functional health. We can try - and already have some methods - to increase elastin production in vivo.

Link: https://foresight.or...life-extension/


View the full article at FightAging

#2 Mind

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Posted 22 October 2021 - 05:27 PM

Super expensive! I can't even get a small animal PK/TOX trial with n=5 for 1 month for less than $100,000.



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#3 Scrittore

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Posted 22 October 2021 - 05:36 PM

I'll take a note.






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