Regenerative Medicine & the Quest for a Longer, Healthier Life

“The tools to enhance and extend our lives are already in our hands. We just need the courage to question outdated assumptions that limit our ability to use them.”

Ray Kurzweil, Inventor & Futurist
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How can we live longer? How do we become healthy enough so that we can extend our lifespans by 5, 10, or even 50 extra years? And it’s not just about living longer, but also feeling younger. For example, what if you could feel 25 at the age of 75? These are the big questions scientists have been trying to answer for decades, with few answers.

While aging itself isn’t a treatable disorder or condition, companies and researchers focused on longevity are looking at bodily processes at the cellular level to see how aging progresses and trying to find the right drugs, treatments, and vitamins that might slow these processes down. And as a result, we may discover the key to longevity or living a longer life.

The regenerative medicine market is enormous, with the global regenerative medicine market projected to expand at a CAGR of 10.3% during the forecast period of 2021 to 2028, according to a research report by Transparency Market Research (TMR). Players operating in the global regenerative medicine market are spreading awareness among the patient pool about the different advantages and disadvantages of regenerative medicines. These efforts are helping enterprises in improving clinical outcomes. At the same time, such initiatives allow patients to make informed decisions about their treatments.

Since the 1980s, when scientist Tom Johnson mapped the first “longevity” gene, there’s been more progress made in understanding how we age and how we can slow it down. And the similarity between aging and age-related diseases is increasingly becoming the focus for many of these longevity research initiatives — many researchers studying age-related diseases like Alzheimer’s are now collaborating with researchers looking at aging more broadly. Recent studies have identified key traits — referred to as hallmarks of aging — that attempt to define what aging is. The primary characteristics are depicted in the graphic below:

Image Credit: The Hallmarks of Aging, PubMed

Some futurists believe that we are nearing a time when we can extend a person’s life expectancy almost indefinitely. For example, Ray Kurzweil speaks about a concept called “longevity escape velocity.” It’s an intriguing notion that soon, science will be able to extend your life by more than a year for every year you are alive. Once that happens, we can begin to think about true longevity. Ray predicts that we’ll reach longevity escape velocity in the next ten to twelve years. Professor George Church of Harvard Medical School echoes that same time frame. Aubrey de Gray, chief science officer of SENS Research Foundation, has been promoting longevity research since 2005 and agrees with Kurzweil and Church.

This model is predicated on the fact that exponential technologies such as AI, CRISPR, gene therapy, DNA reading and writing, robotics, digital manufacturing, sensors, and networks, are accelerating and focusing on health.

“The exponential technologies that have improved the speed and cost of reading, writing, and editing of DNA and gene therapies now apply to the category of aging reversal.”

George Church, Harvard Medical School

I’m not sure I’ve bought into the idea of longevity escape velocity just yet. And I’m not alone. For most, the concept of achieving age reversal or “longevity escape velocity” may sound like science fiction. But, as you can see in the market growth statistics quoted above, venture funds and government programs are pouring billions of dollars into the field every year. Any way you cut it, that is a lot of capital accelerating the rate of healthspan and age-reversal technologies.

Putting aside the technology and investment for a moment, the “other side of the coin” argument that must be addressed is the impact that life extension would have on society. With any new technology used in human health, there are unintentional downstream effects to think about — especially since aging or age-related diseases can be challenging to study due to the length of time needed to fully evaluate a therapy’s full range of effects, both in the short- and long-term.

What about society as a whole? Would it be better off if life spans were doubled? A doubling of the human lifespan will affect society at every level. Notions about marriage, family, and work will change fundamentally, as will attitudes toward the young and the old. Then you have the issue of access to these potential life-extending technologies. Will they only be available to the wealthy and developed nations? Will the poor and developing countries have the resources to access these technologies? While opinions differ wildly about what the ramifications for society will be if the human lifespan is extended, most ethicists agree that the issue should be discussed now since it might be impossible to stop or control the technology once it’s developed.

“We cannot and should not seek to prevent the development of [longevity treatments], any more than we should deny kidney transplants because there are not enough kidneys to go around—in other words, we should develop life-extension even if we cannot provide it to everyone.”

John Harris, Bioethicist

Then there are the regulatory hurdles involved. The FDA considers aging a natural process and won’t approve drugs to treat it. As already mentioned, dozens of companies are now working on therapies that could potentially extend overall human health and lifespan. Still, none of them are working specifically toward approval for aging because the FDA wouldn’t even know where to start. They would like the industry, first, to show that it’s possible to change the rate of aging, which many view as backward, but that’s what they want.

Here are some of the developments I’ll be watching as science and medicine tackle the issue of human longevity and disease:

  • Senolytics: part of a new, emerging area of research known as “senotherapy,” in which senolytics is a key class of therapeutics. Senotherapeutics include geroprotectors — drugs that are supposed to be able to prevent or reverse aging by targeting its cellular triggers, such as damage to the DNA. These drugs are in the early stages, and there’s no guarantee they’ll be approved by the FDA, as mentioned above.
  • Stem cells: Stem cell research is one of the most promising areas in regenerative medicine. Therapeutics derived from placenta stem cells is one example of this growing area of research, and startup Celularity is striving to make this happen.
  • Organ regeneration: As a vital part of regenerative medicine, 3D bioprinting of tissues and organs present a novel way to restore lost structures or functions.
  • Parabiosis: Parabiosis is an experimental procedure that circulates shared blood between a younger and an older animal, according to the National Institute of Aging (part of NIH). One startup working in this area is Elevian, using its GDF11 (Growth Differentiation Factor 11) protein. This naturally occurring circulating factor may decline in older people, although this hasn’t been verified yet.

New anti-aging research efforts are gaining traction. And with technology continuing to provide novel solutions, finding ways to extend our lifespans may not be so far away. While we’re not close to having these fountain of youth treatments on drugstore shelves, we may be seeing the first wave of what could ultimately redefine the human experience – for good or ill is still to be determined.

Some Straight Talk on Digital Therapeutics (DTx) in Health Care

“Digital therapeutics (DTx) deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.”

The Digital Therapeutics Alliance
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A novel trend coming out of the fast-growing mobile health market, digital therapeutics are software products used to treat medical conditions. These products are designed to enable patients to take greater control over their care, similar to consumer wellness apps but with one key difference: Digital therapeutics focus on delivering clinical outcomes.

Particularly important in the definition above is that digital therapeutics are evidence-based, clinically evaluated software. However, while digital therapeutics are software-based, they are subject to the same regulatory oversight that traditional medicines undergo. This ensures that the product is safe to use, effective as well as has a clinical impact. They can also be prescribed independently or in concert with other medications or treatments to optimize patient outcomes.

First, some basic information on digital therapeutics – DTx products represent a new category of evidenced-based therapeutic technologies that support clinicians in delivering high-quality patient care. They address a range of disease states and provide a wide variety of software-based interventions. As defined by The Digital Therapeutics Alliance, DTx products are used independently or in concert with other medical therapies to:

  • Directly impact disease state measures and clinical outcomes
  • Expand access to safe, confidential, and effective medical treatments
  • Provide therapies for previously un- or undertreated conditions
  • Extend clinicians’ ability to care for patients
  • Maximize patient engagement
  • Close gaps in care
  • Lower overall healthcare costs

Digital therapeutics are not at a conceptual stage but are well within the production and delivery stages. DTx targeting chronic medical and mental conditions have been developed over the past 15 to 20 years. The Digital Therapeutics Alliance even has a product library of DTx. This list can be essential as it helps differentiate DTx that physicians can prescribe from unregulated apps that overpopulate online app stores. The organization says that all products claiming to be digital therapeutic must adhere to these foundational principles:

Image Credit: The Digital Therapeutics Alliance

Where are we today? – Extracting some examples from the product library referenced above gives us a sense of some diseases that can benefit from digital therapeutics.

One such product is Insula, a prescription-only software that assists type 2 diabetics in managing their condition. It recommends patients’ personalized insulin doses as well as acts as a coach in managing their diabetes. A randomized trial conducted in France showed that a precursor to the software helped improve glucose control compared with standard care.

Another example is Kaiku Health. The app supports cancer patients by allowing them to report potential symptoms that they might encounter; subsequently, it shares self-care instructions with them. Through Kaiku Health, patients can also message their care team. Studies have shown that such forms of digital monitoring lead to good patient adherence and satisfaction, as well as save time by reducing in-person visits or even phone consultations.

What are some of the challenges in implementing digital therapeutics?Reimbursement and oversight are two significant areas of concern in health care systems, yet the regulatory landscape surrounding DTx is still in flux. The first question that must be answered is who is responsible for regulating DTx. The second is the relation of DTx to machine learning and whether changes in software or updated machine learning algorithms would require reapproval or new approvals. The Total Product Lifecycle approach currently under consideration by the FDA could address some of these concerns.

System-level challenges of DTx also include cybersecurity. DTx interfaces with, and is reliant on, multiple nonmedical entities, including internet, phone, and cloud storage service providers. There are no global answers to these issues, but patients and clinicians alike will be reluctant to transmit sensitive health data over unsecured channels. Moreover, reimbursement for DTx is moving slowly. Some private insurers pay for DTx as prescribed, but nationwide reimbursement codes remain uncommon.

A yet unexplored problem is adherence to DTx use once prescribed; as large-scale implementation becomes a reality, this issue will need to be appropriately addressed. “App burnout,” a phenomenon referring to the short-term use of apps, may be relevant to DTx as the prescribed length of time (i.e., weeks, months, years) increases.

My take on the future of digital therapeutics – Digital therapeutics are not just a fad. They have the potential to address unmet patient needs that traditional treatments and therapies have been unable to meet. The ability of companies that leverage digital therapeutics to address these gaps, in combination with the much faster product development timelines, could give them a significant advantage over traditional life sciences companies.

“Digital therapeutics are poised to shift medicine’s emphasis from physically dosed treatment regimens to end-to-end disease management based on behavioral change.”

The Digital Therapeutics Alliance

The potential of digital therapeutics has players across multiple industries weighing their options. Technology giants are interested in developing and acquiring digital therapeutics to enter and change the health care landscape. Payers are exploring whether digital therapeutics can deliver better quality of life and outcomes while maintaining or reducing the overall cost of care in specific disease areas while independently analyzing how patient data, which could be collected through such products, can be leveraged to inform coverage. Start-ups are coming up with innovative digital therapeutic ideas to attract investors.

Thus far, the main DTx developments have been delivering already proven treatments via electronic/software means. However, the future of DTx will likely include higher-order constructs and products that address comorbid disorders.

Leveraging DTx to improve mental and physical health is likely to be the biggest, paradigm-shifting change that medicine has known since the invention of antibiotics. However, how to apply these tools remains an area that needs operationalization. DTx is at the nexus of digital innovation and scalability/wide-scale use of digital interventions, with more investment and exciting developments on the horizon.