Regenerative medicine has come a long way, baby

Regenerative medicine has come a long way, baby

After a cloned baby sheep, what started as one of the most controversial areas in medicine is now promising to transform it.

Adobe Stock

The field of regenerative medicine had a shaky start. In 2002, when news spread about the first cloned animal, Dolly the sheep, a raucous debate ensued. Scary headlines and organized opposition groups put pressure on government leaders, who responded by tightening restrictions on this type of research.

Fast forward to today, and regenerative medicine, which focuses on making unhealthy tissues and organs healthy again, is rewriting the code to healing many disorders, though it’s still young enough to be considered nascent. What started as one of the most controversial areas in medicine is now promising to transform it.

Progress in the lab has addressed previous concerns. Back in the early 2000s, some of the most fervent controversy centered around somatic cell nuclear transfer (SCNT), the process used by scientists to produce Dolly. There was fear that this technique could be used in humans, with possibly adverse effects, considering the many medical problems of the animals who had been cloned.


But today, scientists have discovered better approaches with fewer risks. Pioneers in the field are embracing new possibilities for cellular reprogramming, 3D organ printing, AI collaboration, and even growing organs in space. It could bring a new era of personalized medicine for longer, healthier lives - while potentially sparking new controversies.

Engineering tissues from amniotic fluids

Work in regenerative medicine seeks to reverse damage to organs and tissues by culling, modifying and replacing cells in the human body. Scientists in this field reach deep into the mechanisms of diseases and the breakdowns of cells, the little workhorses that perform all life-giving processes. If cells can’t do their jobs, they take whole organs and systems down with them. Regenerative medicine seeks to harness the power of healthy cells derived from stem cells to do the work that can literally restore patients to a state of health—by giving them healthy, functioning tissues and organs.

Modern-day regenerative medicine takes its origin from the 1998 isolation of human embryonic stem cells, first achieved by John Gearhart at Johns Hopkins University. Gearhart isolated the pluripotent cells that can differentiate into virtually every kind of cell in the human body. There was a raging controversy about the use of these cells in research because at that time they came exclusively from early-stage embryos or fetal tissue.

Back then, the highly controversial SCNT cells were the only way to produce genetically matched stem cells to treat patients. Since then, the picture has changed radically because other sources of highly versatile stem cells have been developed. Today, scientists can derive stem cells from amniotic fluid or reprogram patients’ skin cells back to an immature state, so they can differentiate into whatever types of cells the patient needs.

In the context of medical history, the field of regenerative medicine is progressing at a dizzying speed. But for those living with aggressive or chronic illnesses, it can seem that the wheels of medical progress grind slowly.

The ethical debate has been dialed back and, in the last few decades, the field has produced important innovations, spurring the development of whole new FDA processes and categories, says Anthony Atala, a bioengineer and director of the Wake Forest Institute for Regenerative Medicine. Atala and a large team of researchers have pioneered many of the first applications of 3D printed tissues and organs using cells developed from patients or those obtained from amniotic fluid or placentas.

His lab, considered to be the largest devoted to translational regenerative medicine, is currently working with 40 different engineered human tissues. Sixteen of them have been transplanted into patients. That includes skin, bladders, urethras, muscles, kidneys and vaginal organs, to name just a few.

These achievements are made possible by converging disciplines and technologies, such as cell therapies, bioengineering, gene editing, nanotechnology and 3D printing, to create living tissues and organs for human transplants. Atala is currently overseeing clinical trials to test the safety of tissues and organs engineered in the Wake Forest lab, a significant step toward FDA approval.

In the context of medical history, the field of regenerative medicine is progressing at a dizzying speed. But for those living with aggressive or chronic illnesses, it can seem that the wheels of medical progress grind slowly.

“It’s never fast enough,” Atala says. “We want to get new treatments into the clinic faster, but the reality is that you have to dot all your i’s and cross all your t’s—and rightly so, for the sake of patient safety. People want predictions, but you can never predict how much work it will take to go from conceptualization to utilization.”

As a surgeon, he also treats patients and is able to follow transplant recipients. “At the end of the day, the goal is to get these technologies into patients, and working with the patients is a very rewarding experience,” he says. Will the 3D printed organs ever outrun the shortage of donated organs? “That’s the hope,” Atala says, “but this technology won’t eliminate the need for them in our lifetime.”

New methods are out of this world

Jeanne Loring, another pioneer in the field and director of the Center for Regenerative Medicine at Scripps Research Institute in San Diego, says that investment in regenerative medicine is not only paying off, but is leading to truly personalized medicine, one of the holy grails of modern science.

This is because a patient’s own skin cells can be reprogrammed to become replacements for various malfunctioning cells causing incurable diseases, such as diabetes, heart disease, macular degeneration and Parkinson’s. If the cells are obtained from a source other than the patient, they can be rejected by the immune system. This means that patients need lifelong immunosuppression, which isn’t ideal. “With Covid,” says Loring, “I became acutely aware of the dangers of immunosuppression.” Using the patient’s own cells eliminates that problem.

Microgravity conditions make it easier for the cells to form three-dimensional structures, which could more easily lead to the growing of whole organs. In fact, Loring's own cells have been sent to the ISS for study.

Loring has a special interest in neurons, or brain cells that can be developed by manipulating cells found in the skin. She is looking to eventually treat Parkinson’s disease using them. The manipulated cells produce dopamine, the critical hormone or neurotransmitter lacking in the brains of patients. A company she founded plans to start a Phase I clinical trial using cell therapies for Parkinson’s soon, she says.

This is the culmination of many years of basic research on her part, some of it on her own cells. In 2007, Loring had her own cells reprogrammed, so there’s a cell line that carries her DNA. “They’re just like embryonic stem cells, but personal,” she said.

Loring has another special interest—sending immature cells into space to be studied at the International Space Station. There, microgravity conditions make it easier for the cells to form three-dimensional structures, which could more easily lead to the growing of whole organs. In fact, her own cells have been sent to the ISS for study. “My colleagues and I have completed four missions at the space station,” she says. “The last cells came down last August. They were my own cells reprogrammed into pluripotent cells in 2009. No one else can say that,” she adds.

Future controversies and tipping points

Although the original SCNT debate has calmed down, more controversies may arise, Loring thinks.

One of them could concern growing synthetic embryos. The embryos are ultimately derived from embryonic stem cells, and it’s not clear to what stage these embryos can or will be grown in an artificial uterus—another recent invention. The science, so far done only in animals, is still new and has not been widely publicized but, eventually, “People will notice the production of synthetic embryos and growing them in an artificial uterus,” Loring says. It’s likely to incite many of the same reactions as the use of embryonic stem cells.

Bernard Siegel, the founder and director of the Regenerative Medicine Foundation and executive director of the newly formed Healthspan Action Coalition (HSAC), believes that stem cell science is rapidly approaching tipping point and changing all of medical science. (For disclosure, I do consulting work for HSAC). Siegel says that regenerative medicine has become a new pillar of medicine that has recently been fast-tracked by new technology.

Artificial intelligence is speeding up discoveries and the convergence of key disciplines, as demonstrated in Atala’s lab, which is creating complex new medical products that replace the body’s natural parts. Just as importantly, those parts are genetically matched and pose no risk of rejection.

These new technologies must be regulated, which can be a challenge, Siegel notes. “Cell therapies represent a challenge to the existing regulatory structure, including payment, reimbursement and infrastructure issues that 20 years ago, didn’t exist.” Now the FDA and other agencies are faced with this revolution, and they’re just beginning to adapt.

Siegel cited the 2021 FDA Modernization Act as a major step. The Act allows drug developers to use alternatives to animal testing in investigating the safety and efficacy of new compounds, loosening the agency’s requirement for extensive animal testing before a new drug can move into clinical trials. The Act is a recognition of the profound effect that cultured human cells are having on research. Being able to test drugs using actual human cells promises to be far safer and more accurate in predicting how they will act in the human body, and could accelerate drug development.

Siegel, a longtime veteran and founding father of several health advocacy organizations, believes this work helped bring cell therapies to people sooner rather than later. His new focus, through the HSAC, is to leverage regenerative medicine into extending not just the lifespan but the worldwide human healthspan, the period of life lived with health and vigor. “When you look at the HSAC as a tree,” asks Siegel, “what are the roots of that tree? Stem cell science and the huge ecosystem it has created.” The study of human aging is another root to the tree that has potential to lengthen healthspans.

The revolutionary science underlying the extension of the healthspan needs to be available to the whole world, Siegel says. “We need to take all these roots and come up with a way to improve the life of all mankind,” he says. “Everyone should be able to take advantage of this promising new world.”

Eve Herold
Eve Herold is an award-winning science writer and consultant in the scientific and medical nonprofit space. A longtime communications and policy executive for scientific organizations, she currently serves as Director of Policy Research and Education for the Healthspan Action Coalition. She has written extensively about issues at the crossroads of science and society, including regenerative medicine, aging and longevity, medical implants, transhumanism, robotics and AI, and bioethical issues in leading-edge medicine. Her books include Stem Cell Wars and Beyond Human, and her latest book, Robots and the People Who Love Them, will be released in January 2024. Her work has appeared in Vice, Medium, The Washington Post and the Boston Globe, among others. She’s a frequent contributor to Leaps.org and is the recipient of the 2019 Arlene Eisenberg Award from the American Society of Journalists and Authors.
New study: Hotter nights, climate change, cause sleep loss with some affected more than others

According to a new study, sleep is impaired with temperatures over 50 degrees, and temps higher than 77 degrees reduce the chances of getting seven hours.

Photo by Altınay Dinç on Unsplash

Data from the National Sleep Foundation finds that the optimal bedroom temperature for sleep is around 65 degrees Fahrenheit. But we may be getting fewer hours of "good sleepin’ weather" as the climate warms, according to a recent paper from researchers at the University of Copenhagen, Denmark.

Published in One Earth, the study finds that heat related to climate change could provide a “pathway” to sleep deprivation. The authors say the effect is “substantially larger” for those in lower-income countries. Hours of sleep decline when nighttime temperature exceeds 50 degrees, and temps higher than 77 reduce the chances of sleeping for seven hours by 3.5 percent. Even small losses associated with rising temperatures contribute significantly to people not getting enough sleep.

We’re affected by high temperatures at night because body temperature becomes more sensitive to the environment when slumbering. “Mechanisms that control for thermal regulation become more disordered during sleep,” explains Clete Kushida, a neurologist, professor of psychiatry at Stanford University and sleep medicine clinician.

The study finds that women and older adults are especially vulnerable. Worldwide, the elderly lost over twice as much sleep per degree of warming compared to younger people. This phenomenon was apparent between the ages of 60 and 70, and it increased beyond age 70. “The mechanism for balancing temperatures appears to be more affected with age,” Kushida adds.

Keep Reading Keep Reading
Sherree Geyer
Sherree Geyer is a freelance health journalist. She regularly writes for “Pain Medicine News,” “Pharmacy Practice News” and other trade publications. A member of the Association of Healthcare Journalists, National Association of Science Writers and National Writers Union, she holds a bachelor’s degree in journalism from Northern Illinois University.
Why we need to get serious about ending aging

With the population of older people projected to grow dramatically, and the cost of healthcare with it, the future welfare of the country may depend on solving aging, writes philosopher Ingemar Patrick Linden.

Photo by Alessio Lin on Unsplash

It is widely acknowledged that even a small advance in anti-aging science could yield benefits in terms of healthy years that the traditional paradigm of targeting specific diseases is not likely to produce. A more youthful population would also be less vulnerable to epidemics. Approximately 93 percent of all COVID-19 deaths reported in the U.S. occurred among those aged 50 or older. The potential economic benefits would be tremendous. A more youthful population would consume less medical resources and be able to work longer. A recent study published in Nature estimates that a slowdown in aging that increases life expectancy by one year would save $38 trillion per year for the U.S. alone.

A societal effort to understand, slow down, arrest or even reverse aging of at least the size of our response to COVID-19 would therefore be a rational commitment. In fact, given that America’s older population is projected to grow dramatically, and the cost of healthcare with it, it is not an overstatement to say that the future welfare of the country may depend on solving aging.

This year, the kingdom of Saudi Arabia has announced that it will spend up to 1 billion dollars per year on science with the potential to slow down the aging process. We have also seen important investments from billionaires like Google co-founder Larry Page, Amazon founder Jeff Bezos, business magnate Larry Ellison, and PayPal co-founder Peter Thiel.

The U.S. government, however, is lagging: The National Institutes of Health spent less than one percent of its $43 billion budget for the fiscal year of 2021 on the National Institute on Aging’s Division of Aging Biology. When you visit the division’s webpage you find that their mission statement carefully omits any mention of the possibility of slowing down the aging process.

Keep Reading Keep Reading
Ingemar Patrick Linden
Driven by a passion to probe the fundamental questions we are confronted with, Dr. INGEMAR PATRICK LINDEN has been on a journey of discovery taking him from Lund University in Sweden, to UCL in London, to University of California, to New York, where he has taught philosophy for almost a decade. Death. It does not get more fundamental than that. One of the ideas that has remained a firm conviction of the author’s since childhood is that we do not have enough time. We are but the beginnings of complete humans, fragments of what we could be. It was the realization that not all share this view, in fact, surveys show that most do not, that inspired, and necessitated, the writing of THE CASE AGAINST DEATH.