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Month: March 2018

U.S. Transhumanist Party to Participate in RAAD Fest 2018

U.S. Transhumanist Party to Participate in RAAD Fest 2018

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Gennady Stolyarov II


The U.S. Transhumanist Party will again be represented at RAAD Fest in San Diego. Chairman Gennady Stolyarov II will be attending RAAD Fest 2018 and will be moderating a panel of speakers as well as presenting regarding the accomplishments of the Transhumanist Party over the most recent year as of September 20-23, 2018. There will be an opportunity for a sizable Transhumanist Party presence, and we are contemplating a meeting of U.S. Transhumanist Party members that would be open to the public and media.

It is possible to register for RAAD Fest 2018 at the website raadfest.com. By entering the code TRANSHUMAN, attendees will be able to save $50 off of the cost of registration.

More details regarding Mr. Stolyarov’s presence and activities at RAAD Fest 2018 will be announced as they become available. We look forward to seeing you there!

Announcement of California Transhumanist Party 2nd Leadership Meeting on Sunday, April 22, 2018

Announcement of California Transhumanist Party 2nd Leadership Meeting on Sunday, April 22, 2018

Newton Lee


I am pleased to announce our 2nd Leadership Meeting on Earth Day, Sunday, April 22nd, 2018, at Woodbury University with a special treat: combining a peace conference movie screening and a Transhumanist Party meeting.

Sunday, April 22, 2018

Woodbury University

7500 N Glenoaks Blvd, Burbank, CA 91504

2 p.m. – 4 p.m.  Movie screening “Winds of Freedom” with Q&A at Fletcher Jones Auditorium (in the School of Business)

4 p.m. – 5 p.m.  California Transhumanist Party leadership meeting at Isaacs Faculty Center (same building as our last meeting)

Please mark your calendar, and order your free tickets online:

https://www.eventbrite.com/e/2018-earth-day-peace-conference-movie-screening-tickets-44054010732

Thank you, and see you on Earth Day 2018!

Newton Lee

Education and Media Advisor, United States Transhumanist Party (USTP)

Chairman, California Transhumanist Party (CTP)

http://www.CaliforniaTranshumanistParty.org

LinkedIn: https://www.linkedin.com/in/newtonlee/

The U.S. Transhumanist Party Responds to Jeremy Rifkin’s Plan for a Third Industrial Revolution

The U.S. Transhumanist Party Responds to Jeremy Rifkin’s Plan for a Third Industrial Revolution

Gennady Stolyarov II


Photograph of Jeremy Rifkin by Stephan Röhl

Editor’s Note: Below is a response to Jeremy Rifkin’s plan for a Third Industrial Revolution: A Radical New Sharing Economy by Gennady Stolyarov II, Chairman of the U.S. Transhumanist Party. The original post of this documentary can be found here.

    ~ Dinorah Delfin, Director of Admissions and Public Relations, U.S. Transhumanist Party, March 10, 2018

When it comes to Jeremy Rifkin’s thoughts on the future, and what humankind will and will not be able to accomplish, Arthur C. Clarke’s famous First Law encapsulates my reaction: “When a distinguished but elderly scientist states that something is possible, he is almost certainly right. When he states that something is impossible, he is very probably wrong.”

I think that Rifkin has many ideas that would be aligned with transhumanism, although his general worldview is not transhumanist in itself. I wholly support the concepts of the sharing economy, the goal of production at zero marginal cost, and the smart infrastructure that he describes would support the Third Industrial Revolution. A redesign of our infrastructure – especially in such a way that would facilitate modular upgrades at a local and even individual level – is essential for overcoming some of the current bottlenecks to technological progress and rising standards of living. I also think that Rifkin is correct that, in the short term, building this new infrastructure will require humans and will mean jobs for those humans. This is probably a good thing, although it is dependent on whether the systems for financing the new projects and appropriately recruiting and treating the workers (e.g., giving them high-quality jobs with good pay, safety precautions, and ample assistance from machines and narrow AIs where possible) can come together in time.

Where I think Rifkin falls short of the transhumanist vision is in his rejection of the goal of a society where basic human problems – including mortality and many of the other key causes of suffering – can be eliminated or at least greatly reduced. He characterizes this as “utopian” thinking, but at every stage of the way, the approach toward these goals would not be utopia, but rather steady improvement. It would be a shame to reject the goals especially as the technologies for making them possible are becoming available. As I have often stated, it is not a matter of if we will have indefinite life extension, but when – and this matters a lot from the standpoint of how many people alive today could be saved.

Where I also differ from Rifkin is that, instead of his focus on the negative (“humans are destroying the Earth”), I and the Transhumanist Party prefer to focus on the positive potentials (humans can improve both our own lives and the Earth through emerging technologies). Many of the solutions may look quite similar – e.g., smart infrastructure, greater energy-efficiency, and renewable energy sources that would move humankind away from fossil fuels (although, unlike Rifkin, I also strongly support the next generation of nuclear reactors, which would use thorium, would be meltdown-proof, and would not be subject to the need for cooling via massive amounts of water that Rifkin criticizes). I think that the way forward is through technological advancement; Rifkin is halfway there – certainly much better than the Neo-Luddite thinkers who have often dominated the environmental movement. But his goals are not in conflict with life extension, massive economic growth, and super-abundance of material prosperity for everyone. In fact, humans need to move along all of these avenues simultaneously and in parallel, as their achievements will reinforce one another and enable progress to occur more readily.

Article III, Section IX of our Platform – http://transhumanist-party.org/constitution/#Article3 – actually summarizes this sentiment quite nicely: “The United States Transhumanist Party supports all emerging technologies that have the potential to improve the human condition – including but not limited to autonomous vehicles, electric vehicles, economical solar power, safe nuclear power, hydroelectricity, geothermal power, applications for the sharing of durable goods, artificial intelligence, biotechnology, nanotechnology, robotics, rapid transit, 3D printing, vertical farming, electronic devices to detect and respond to trauma, and beneficial genetic modification of plants, animals, and human beings.”

Again, Clarke’s First Law comes to mind. To the extent that Rifkin sees potential in any of the above technologies and others, he is correct. To the extent that he does not see it or considers those technologies to be detrimental, he is mistaken.

Beginners’ Explanation of Transhumanism – Bobby Ridge and Gennady Stolyarov II

Beginners’ Explanation of Transhumanism – Bobby Ridge and Gennady Stolyarov II

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Bobby Ridge
Gennady Stolyarov II


Bobby Ridge, Secretary-Treasurer of the U.S. Transhumanist Party, and Gennady Stolyarov II, Chairman of the U.S. Transhumanist Party, provide a broad “big-picture” overview of transhumanism and major ongoing and future developments in emerging technologies that present the potential to revolutionize the human condition and resolve the age-old perils and limitations that have plagued humankind.

This is a beginners’ overview of transhumanism – which means that it is for everyone, including those who are new to transhumanism and the life-extension movement, as well as those who have been involved in it for many years – since, when it comes to dramatically expanding human longevity and potential, we are all beginners at the beginning of what could be our species’ next great era.

Become a member of the U.S. Transhumanist Party for free, no matter where you reside.

See Mr. Stolyarov’s presentation, “The U.S. Transhumanist Party: Pursuing a Peaceful Political Revolution for Longevity“.

In the background of some of the video segments is a painting now owned by Mr. Stolyarov, from “The Singularity is Here” series by artist Leah Montalto.

Boosting Bone Healing Using a Key Protein – Article by Steve Hill

Boosting Bone Healing Using a Key Protein – Article by Steve Hill

Steve Hill


Editor’s Note: In this article, Mr. Steve Hill highlights research on selective bone regeneration using a protein called Jagged-1. This article was originally published by the Life Extension Advocacy Foundation (LEAF).

                   ~ Kenneth Alum, Director of  Publication, U.S. Transhumanist Party, March 7, 2018

Today, we would like to highlight a recent study in which researchers show a way to selectively accelerate bone regeneration. They have achieved this by delivering Jagged-1 to injuries instead of the bone morphogenetic proteins (BMPs) that have been traditionally used.

What is Jagged-1?

Jagged-1 is an osteoinductive protein that activates the Notch signaling pathway, which regulates bone healing at the site of injury. Osteoinduction is the process by which osteogenesis is induced.

Osteoinduction involves recruiting immature cells and stimulating them to change into preosteoblasts. In a bone healing situation, such as during a fracture, the majority of bone healing depends on osteoinduction.

The new technique avoids the issues of inappropriate or excessive bone growth because, unlike BMPs, it targets osteoinductive mechanisms that are more directly associated with the regenerative process.

Testing their hypothesis

The researchers led by Kurt Hankenson, D.V.M., Ph.D., a professor of orthopedic surgery at Michigan Medicine, hypothesized for some years that by binding Jagged-1 to a biomaterial structure and delivering it to the site of injury, it could improve healing of the bone.

The published study results confirm this to be the case [1]. Mice and rats that were given Jagged-1, applied using a wet collagen sponge, saw improvements to both femoral and skull injuries. In contrast, the rodents treated with BMPs benefited but also experienced problematic bone hypertrophy, which is also observed in humans using BMPs.

The findings of this study suggest that the use of Jagged-1 for location-specific bone injury could potentially be developed into a therapy to help people recover from fractures and broken bones.

Conclusion

The use of signal molecules rather than drugs to encourage tissue regeneration is likely to increase in popularity in the coming years as the process becomes increasingly refined. This study is yet another example of how researchers are exploring the use of signalling molecules produced naturally in the body as an alternative to drug approaches, which can often have unwanted side effects. It should prove interesting to see how this approach develops in the next few years.

Literature

[1] Youngstrom, D. W., Senos, R., Zondervan, R. L., Brodeur, J. D., Lints, A. R., Young, D. R., … & Loomes, K. M. (2017). Intraoperative delivery of the Notch ligand Jagged-1 regenerates appendicular and craniofacial bone defects. NPJ Regenerative medicine, 2(1), 32.

About  Steve Hill

As a scientific writer and a devoted advocate of healthy longevity technologies, Steve has provided the community with multiple educational articles, interviews and podcasts, helping the general public to better understand aging and the means to modify its dynamics. His materials can be found at H+ Magazine, Longevity reporter, Psychology Today and Singularity Weblog. He is a co-author of the book “Aging Prevention for All” – a guide for the general public exploring evidence-based means to extend healthy life (in press).

About LIFE EXTENSION ADVOCACY FOUNDATION (LEAF)

In 2014, the Life Extension Advocacy Foundation was established as a 501(c)(3) non-profit organization dedicated to promoting increased healthy human lifespan through fiscally sponsoring longevity research projects and raising awareness regarding the societal benefits of life extension. In 2015 they launched Lifespan.io, the first nonprofit crowdfunding platform focused on the biomedical research of aging.

They believe that this will enable the general public to influence the pace of research directly. To date they have successfully supported four research projects aimed at investigating different processes of aging and developing therapies to treat age-related diseases.

The LEAF team organizes educational events, takes part in different public and scientific conferences, and actively engages with the public on social media in order to help disseminate this crucial information. They initiate public dialogue aimed at regulatory improvement in the fields related to rejuvenation biotechnology.

Dentists May Soon Regenerate Teeth Using GSK3 Antagonists – Article by Steve Hill

Dentists May Soon Regenerate Teeth Using GSK3 Antagonists – Article by Steve Hill

Steve Hill


Editor’s Note: In this article, Mr. Steve Hill explains a teeth-regeneration technique that works by activating the stem cells that reside in the dental pulp of teeth. The technique has the potential to translate to other tissues to help encourage regeneration. This article was originally published by the Life Extension Advocacy Foundation (LEAF).

                   ~ Kenneth Alum, Director of  Publication, U.S. Transhumanist Party, March 6, 2018

What if I told you that we could regenerate our teeth? Well, that may soon be a possibility thanks to new research showing that teeth can be encouraged to regrow. Rather than drilling holes into teeth and plugging them with artificial fillers, dentists in the near future may be able to rebuild your teeth with a new technique.

Stimulating stem cells

Professor Paul Sharpe, a scientist based at King’s College in London, and his team have found a way to do just this in mice. They published a study last year that described this new approach [1].

The researchers wanted to increase the natural ability of teeth to repair themselves by activating the stem cells that reside in the dental pulp of teeth. They knew that previous research showed that the wnt signaling pathway is a key pathway for stem cell activity in many parts of the body, and they wanted to see if it works the same way in teeth.

The researchers believed by that using drugs to stimulate the wnt pathway, they could increase stem cell activity in teeth and boost their regenerative potential significantly. Normally, this level of regeneration is only seen in animals like starfish and salamanders, but the researchers wanted to see if we can benefit from the same regenerative capacity.

To see if this would work, the team drilled holes into the molar teeth of mice to simulate dental cavities. Next, they exposed collagen sponges (the same protein found in the dentin in teeth) to a variety of drugs known to stimulate the wnt pathway. Then, they placed these sponges into the cavities and sealed them in for between 4 to 6 weeks.

After this time, the researchers saw that the teeth exposed to these sponges had created a lot more dentin than the control mice and mice given typical dental fillers. The researchers observed that this was essentially a full repair and, in most cases, the teeth of the mice were as good as new.

The next step towards clinical trials

Since then, the researchers have tested the technique on rats, which have considerably larger teeth than mice, making them the logical next step. The research team report that the therapy worked equally well on the rats as it did in the mice in the original study; however, the data is yet to be published.

The researchers are now screening their drug candidates to identify the most effective of the wnt-stimulating drugs. They are also adapting the technique to work with modern dental practices by injecting a gel containing the drug into a dental cavity and hardening it using a UV light to seal it in. This is similar to how dentists currently seal and repair teeth, so this technique would be easy to incorporate into dental practice.

Literature

It will be several years before this enters human clinical trials, but the results so far are promising, and the process may be quicker than normal because a number of the candidate drugs are already approved for human use. The arrival of this technique will revolutionize dentistry and is a great step forward for regenerative medicine in general.

Such techniques have the potential to translate to other tissues to help encourage regeneration, so it is also relevant to aging research. We look forward to more developments from this team in the future.

References

[1] Neves, V. C., Babb, R., Chandrasekaran, D., & Sharpe, P. T. (2017). Promotion of natural tooth repair by small molecule GSK3 antagonists. Scientific reports, 7, 39654.

About  Steve Hill

As a scientific writer and a devoted advocate of healthy longevity technologies Steve has provided the community with multiple educational articles, interviews and podcasts, helping the general public to better understand aging and the means to modify its dynamics. His materials can be found at H+ Magazine, Longevity reporter, Psychology Today and Singularity Weblog. He is a co-author of the book “Aging Prevention for All” – a guide for the general public exploring evidence-based means to extend healthy life (in press).

About LIFE EXTENSION ADVOCACY FOUNDATION (LEAF)

In 2014, the Life Extension Advocacy Foundation was established as a 501(c)(3) non-profit organization dedicated to promoting increased healthy human lifespan through fiscally sponsoring longevity research projects and raising awareness regarding the societal benefits of life extension. In 2015 they launched Lifespan.io, the first nonprofit crowdfunding platform focused on the biomedical research of aging.

They believe that this will enable the general public to influence the pace of research directly. To date they have successfully supported four research projects aimed at investigating different processes of aging and developing therapies to treat age-related diseases.

The LEAF team organizes educational events, takes part in different public and scientific conferences, and actively engages with the public on social media in order to help disseminate this crucial information. They initiate public dialogue aimed at regulatory improvement in the fields related to rejuvenation biotechnology.

Exosome Therapy Repairs Stroke-Damaged Brain Tissue – Article by Steve Hill

Exosome Therapy Repairs Stroke-Damaged Brain Tissue – Article by Steve Hill

Steve Hill


Editor’s Note: In this article, Mr. Steve Hill explains a new therapy that uses exosomes to repair damaged brain cells. The human trials are intended to begin in the year 2019. This article was originally published by the Life Extension Advocacy Foundation (LEAF).

                   ~ Kenneth Alum, Director of  Publication, U.S. Transhumanist Party, March 5, 2018

Today, we wanted to highlight more progress in a rapidly advancing area of medicine and talk about a new study that uses an exosomes-based approach for stroke treatment that repairs brain tissue.

A stem cell-based approach to treating stroke

Professor Steven Stice from the University of Georgia (UGA) and Nasrul Hoda of Augusta University led the team that developed AB126, a treatment that uses a type of extracellular vesicle known as an exosome [1]. Exosomes are small fluid-filled structures that are created by stem cells and, in the case of AB126, are produced by human neural stem cells.

Essentially, the researchers are isolating the beneficial signals given out by stem cells and using them rather than the stem cells as a therapy. This makes sense, as other cells react to these signals and change their behavior accordingly. We have talked about the therapeutic potential of extracellular vesicles, particularly exosomes, in a previous article.

An exosome can remain hidden in the bloodstream, carry multiple doses, and store and administer treatment, and its small size allows it to cross barriers that cells cannot. This is ideal for delivering therapies to the brain, as it crosses the blood-brain barrier and other checkpoints in the body.

After the administration of AB126,  the researchers used MRI scans to assess brain atrophy rates in an animal model of stroke. The scans showed around 35 percent decrease in the size of injury and a 50 percent reduction in brain tissue loss. These results were also replicated by Franklin West, associate professor of animal and dairy science at UGA, in a pig model of stroke.

Within days, the researchers observed improved mobility, better balance, and measurable behavioral benefits in treated animal models of stroke.

Based on the successful results of these preclinical tests, the next step is to take this therapy to human clinical trials by 2019 via ArunA Biomedical, a UGA startup company. The company plans to expand its scope beyond stroke, and preclinical studies in epilepsy, traumatic brain, and spinal cord injuries begin later this year.

Conclusion

This is another example of the recent interest in using extracellular vesicles, such as exosomes, as therapies rather than stem cells themselves. Multiple research groups are now developing these therapies to treat various age-related diseases, so we can almost certainly expect to hear more in the near future.

The use of extracellular vesicles also holds the promise of being more cost-effective from the point of view of storage, logistics, manufacture, and delivery. With the first clinical trials now in the cards for the near future, it will be interesting to see how this develops in the next few years.

References

[1] Webb, R. L., Kaiser, E. E., Scoville, S. L., Thompson, T. A., Fatima, S., Pandya, C., … & Baban, B. (2017). Human Neural Stem Cell Extracellular Vesicles Improve Tissue and Functional Recovery in the Murine Thromboembolic Stroke Model. Translational stroke research, 1-10.

About  Steve Hill

As a scientific writer and a devoted advocate of healthy longevity technologies Steve has provided the community with multiple educational articles, interviews and podcasts, helping the general public to better understand aging and the means to modify its dynamics. His materials can be found at H+ Magazine, Longevity reporter, Psychology Today and Singularity Weblog. He is a co-author of the book “Aging Prevention for All” – a guide for the general public exploring evidence-based means to extend healthy life (in press).

About LIFE EXTENSION ADVOCACY FOUNDATION (LEAF)

In 2014, the Life Extension Advocacy Foundation was established as a 501(c)(3) non-profit organization dedicated to promoting increased healthy human lifespan through fiscally sponsoring longevity research projects and raising awareness regarding the societal benefits of life extension. In 2015 they launched Lifespan.io, the first nonprofit crowdfunding platform focused on the biomedical research of aging.

They believe that this will enable the general public to influence the pace of research directly. To date they have successfully supported four research projects aimed at investigating different processes of aging and developing therapies to treat age-related diseases.

The LEAF team organizes educational events, takes part in different public and scientific conferences, and actively engages with the public on social media in order to help disseminate this crucial information. They initiate public dialogue aimed at regulatory improvement in the fields related to rejuvenation biotechnology.

Gene Cocktail Helps Hearts to Regenerate – Article by Steve Hill

Gene Cocktail Helps Hearts to Regenerate – Article by Steve Hill

Steve Hill


Editor’s Note: In this article, Steve Hill explains a technique that enables significant human tissue regeneration, so that it becomes possible to repair damaged human hearts. This technique can also be potentially applied to other body organs.  This article was originally published by the Life Extension Advocacy Foundation (LEAF).

                   ~ Kenneth Alum, Director of  Publication, U.S. Transhumanist Party, March 4, 2018

The human heart is an organ whose cells rarely divide, making tissue repair and regeneration a huge problem following a heart attack. Many animals, such as zebrafish and salamanders, are different; they can regenerate damaged hearts easily.

As humans, we also once had the same regenerative capacity during our early development, but after we were born, we lost this ability. This is also true for many other organs, including the brain, spinal cord, and pancreas. The cells in these tissues divide very rarely if at all, and this is a big problem. But, what if we could get that regenerative ability back and repair damage to our hearts the way these amazing animals do?

Researchers have been trying for decades to find out how we can enjoy the same tissue regeneration, but they have met with limited success—until now.

Unlocking cell division in cardiomyocytes

A research team led by Dr. Deepak Srivastava, president of the Gladstone Institutes, has finally achieved this long sought-after goal in a study published in the journal Cell [1]. The researchers have developed an efficient and reliable way of making non-dividing adult cardiomyocytes divide so that they can repair damaged hearts.

They identified four genes that regulate cell division in adult cardiomyocytes. When all four of them are combined together, they cause the cardiomyocytes to re-enter the cell cycle and start dividing quickly. They also demonstrated that following heart failure, these combined genes improve cardiac function significantly.

The researchers tested the technique in animal models using cardiomyocytes derived from human stem cells. They stained newly divided cells with a special dye in order to track them; they found that between 15 to 20 percent of the cells divided and remained alive thanks to the four-gene combo. This is a vast improvement on previous studies, which have only managed around 1 percent cell division in adult cardiomyocytes.

The team also made the technique simpler by identifying drugs that could replace two of the four genes involved in the combination. This still produced the same result as using all four genes and is significantly easier, logistically speaking.

Could be used in multiple tissues

As mentioned, the heart is not the only tissue that has cells that either do not divide or do so very slowly. The researchers believe that their technique could also potentially be applied to encourage other tissues and organs to regenerate. This is because the four genes are not unique to the heart and are found in other cells around the body.

If science can unlock the same regeneration in nerve cells, pancreatic cells, and retinal cells, this could be the basis of therapies for heart failure, brain damage, diabetes, blindness, and many other conditions. The good news is these four genes encourage cell division the same way in mice, rats, and human cells.

Conclusion

Manipulating non-dividing cells and returning them to the cell cycle to boost regeneration in organs and tissues holds great potential. Scientists have been working for decades to achieve this in the heart, and now it has been achieved. The next big step is to translate this approach to humans, and we wish them the very best in their future research.

Literature

[1] Mohamed, T. M., Ang, Y. S., Radzinsky, E., Zhou, P., Huang, Y., Elfenbein, A., … & Srivastava, D. (2017). Regulation of Cell Cycle to Stimulate Adult Cardiomyocyte Proliferation and Cardiac Regeneration.

About  Steve Hill

As a scientific writer and a devoted advocate of healthy longevity technologies Steve has provided the community with multiple educational articles, interviews and podcasts, helping the general public to better understand aging and the means to modify its dynamics. His materials can be found at H+ Magazine, Longevity reporter, Psychology Today and Singularity Weblog. He is a co-author of the book “Aging Prevention for All” – a guide for the general public exploring evidence-based means to extend healthy life (in press).

About LIFE EXTENSION ADVOCACY FOUNDATION (LEAF)

In 2014, the Life Extension Advocacy Foundation was established as a 501(c)(3) non-profit organization dedicated to promoting increased healthy human lifespan through fiscally sponsoring longevity research projects and raising awareness regarding the societal benefits of life extension. In 2015 they launched Lifespan.io, the first nonprofit crowdfunding platform focused on the biomedical research of aging.

They believe that this will enable the general public to influence the pace of research directly. To date they have successfully supported four research projects aimed at investigating different processes of aging and developing therapies to treat age-related diseases.

The LEAF team organizes educational events, takes part in different public and scientific conferences, and actively engages with the public on social media in order to help disseminate this crucial information. They initiate public dialogue aimed at regulatory improvement in the fields related to rejuvenation biotechnology.

New FDA Regenerative Medicine Framework is Win-Win for Gene Therapies – Article by Keith Comito and Elena Milova

New FDA Regenerative Medicine Framework is Win-Win for Gene Therapies – Article by Keith Comito and Elena Milova

Elena Milova
Keith Comito


Editor’s Note: In this article, Keith Comito and Elena Milova positively discuss new a FDA regulatory framework on RMAT (regenerative medicine advanced therapies) and on how it benefits the healthy-life-extension community. This article was originally published by the Life Extension Advocacy Foundation (LEAF).

                   ~ Kenneth Alum, Director of  Publication, U.S. Transhumanist Party, March 3, 2018

Back in November 2017, the FDA announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. Both draft guidance documents had 90-day comment periods, and we at LEAF joined forces with the Niskanen Center to submit comments to the FDA to ensure that the voice of the community for healthy life extension was heard. These new regulations could have considerable implications for the therapies and technologies being developed as part of the biomedical gerontology field.

The first draft guidance addresses how the FDA intends to optimize its regulatory requirements for devices used in the recovery, isolation, and delivery of RMATs (regenerative medicine advanced therapies), including combination products.

The second document explains what expedited programs may be available to sponsors of regenerative medicine therapies and describes what therapies may be eligible for RMAT designation.

According to new FDA regulations, a drug is eligible for designation as an RMAT if:

  • The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;
  • The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
  • Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition

We hope that this joint project will support the improvement of US regulations that concern these innovative treatments and will make the overall regulatory landscape more friendly. Below, we cite the most important notes from our resulting paper.

Last week, the Niskanen Center joined with the Life Extension Advocacy Foundation in filing comments to the Food and Drug Administration (FDA), offering our support for the agency’s new regenerative medicine advanced therapy (RMAT) designation draft guidance for industry.

Although there are opportunities for marginal improvements to the guidance, and FDA approval processes more generally, we are happy to see that the agency chose to include gene therapies in its interpretation of what qualifies as a regenerative medicine therapy.

Under section 3033 of the 21st Century Cures Act, the FDA was tasked with developing an accelerated approval process for regenerative advanced therapies. Such therapies would qualify for expedited review and approval so long as the drug (a) met the definition of a regenerative medicine therapy, (b) was “intended to treat, modify, reverse, or cure a serious condition,” and (c) “has the potential to address unmet medical needs” for a serious disease or condition. Unfortunately, the bill’s definition of a regenerative medicine advanced therapy was unclear on whether gene therapies, in particular, would qualify. Luckily, the FDA clarified this point. As the RMAT guidance document notes:

gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues may meet the definition of a regenerative medicine therapy. Additionally, a combination product (biologic-device, biologic-drug, or biologic-device-drug) can be eligible for RMAT designation when the biological product component provides the greatest contribution to the overall intended therapeutic effects of the combination product.

This is an excellent development and one that portends immense benefits for future gene therapy applications submitted for FDA approval. According to the guidance, the new RMAT designation, unlike other fast-track approval and review processes, “does not require evidence to indicate that the drug may offer a substantial improvement over available therapies.” Liberalizing the threshold standards of evidence for RMAT designation ensures that future gene therapies will encounter fewer unnecessary roadblocks in delivering more effective and innovative treatments for individuals suffering from debilitating diseases.

As we note in our concluding remarks:

Overall, we consider the RMAT guidance to be a stellar improvement over other expedited programs, especially in its qualifying criteria. However, greater clarity is needed in order to capture the benefits of more advanced cell therapies that can help contribute to the healthy aging and well-being of American citizens. As FDA Commissioner Scott Gottlieb recently noted: “The benefits of [gene therapy] science—and the products that become available—are likely to accelerate. How we define the modern framework for safely advancing these opportunities will determine whether we’re able to fully realize the benefits that these new technologies can offer.”

We agree wholeheartedly. Developing a regulatory framework that accommodates safety and innovation will be a key determinant of how quickly the benefits of regenerative medicine, gene therapy, and anti-aging research revolutionize the lives of Americans. This guidance is an important and promising step in the right direction. With the right modifications, it can help usher in a new age of healthcare improvement for individuals from all walks of life.

Read the full comments submitted to the FDA here.

Source: Niskanen Center

About Elena Milova

As a devoted advocate of rejuvenation technologies since 2013, Elena is providing the community with a systemic vision how aging is affecting our society. Her research interests include global and local policies on aging, demographic changes, public perception of the application of rejuvenation technologies to prevent age-related diseases and extend life, and related public concerns. Elena is a co-author of the book “Aging prevention for all” (in Russian, 2015) and the organizer of multiple educational events helping the general public adopt the idea of eventually bringing aging under medical control.

About Keith Comito

Keith Comito is President of LEAF / Lifespan.io and a long-time advocate of longevity research. He is also a computer programmer, mathematician, musician, lover of life and perhaps a man with too many hobbies. He earned a B.S. in Mathematics, B.S. in Computer science, and M.S. in Applied Mathematics at Hofstra University, where his work included analysis of the LMNA protein.

About LIFE EXTENSION ADVOCACY FOUNDATION (LEAF)

In 2014, the Life Extension Advocacy Foundation was established as a 501(c)(3) non-profit organization dedicated to promoting increased healthy human lifespan through fiscally sponsoring longevity research projects and raising awareness regarding the societal benefits of life extension. In 2015 they launched Lifespan.io, the first nonprofit crowdfunding platform focused on the biomedical research of aging.

They believe that this will enable the general public to influence the pace of research directly. To date they have successfully supported four research projects aimed at investigating different processes of aging and developing therapies to treat age-related diseases.

The LEAF team organizes educational events, takes part in different public and scientific conferences, and actively engages with the public on social media in order to help disseminate this crucial information. They initiate public dialogue aimed at regulatory improvement in the fields related to rejuvenation biotechnology.