Advancing the Science

Mayo Clinic Medical Science Blog – an eclectic collection of research- and research education-related stories: feature stories, mini news bites, learning opportunities, profiles and more from Mayo Clinic.

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1 day ago · Preparing the regenerative medicine leaders of the future

With the click of a mouse, medical students opened a window into the health care of the future. The 2020 Mayo Clinic Regenerative Medicine and Surgery Course, a foundation for transformative change, moved online this year due to social distancing guidelines around COVID-19.  Regenerative medicine is a shift from treating disease to restoring health. The week-long patient-centric regenerative medicine-intensive course is designed to prepare the next generation of physicians and scientists to apply emerging regenerative approaches to the practice.

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Fredric Meyer, M.D.

“Mayo Clinic puts a high priority on regenerative sciences as an investment in the health care of the future. It represents a new paradigm in health care. It is vital that students take a regenerative lens toward treating diseases,” says Fredric Meyer, M.D., executive dean, Mayo Clinic College of Medicine and Science. “Beyond regenerative curricula dedicated to medical students, Mayo is one of the first academic medical institutions to establish master’s and doctoral programs in regenerative sciences.”

Traditionally delivered in-person at Mayo Clinic in Rochester, the course was quickly converted to an online, digital format. Online modules included a virtual human laboratory session featuring demonstrations of stem cell therapies, simulated regenerative telemedicine patient consults, live-broadcast video tours of clinical grade manufacturing facilities for regenerative products, patient interactions, career panels and group discussions.

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Saranya Wyles, M.D., Ph.D.

“The online learning platform catalyzed a global community of next-generation learners.  Group learning was further facilitated by online information sharing, allowing students to post questions, review journal articles and engage with the virtual community,” says Saranya Wyles, M.D., Ph.D., course director.

Amanda Terlap is a Ph.D. student in the Mayo Clinic Graduate School of Biomedical Sciences whose thesis is focused on viral infections. She enrolled in the course to get a full overview of regenerative medicine from both patient and clinician perspectives.

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Amanda Terlap

“I now have a better understanding of just how powerful regenerative medicine can be and the extraordinary impact it can have on patients. I have learned about potential opportunities that can evolve my research. I believe that regenerative medicine is the foundation in which cures will be made. It is inspiring,” she says.

Valerie Melson is a first year medical student who is leaning toward specializing in obstetrics and gynecology. She had heard about the diverse points of regenerative procedures involving stem cells, but also sees regenerative medicine as an area of practice that could bring breakthrough cures to patients. She was eager to learn from the experts.

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Valerie Melson

“My belief is that regenerative medicine and the novel ways it tries to address problems is the future of medicine. The course gave me tangible ways in which physicians identified shortcomings in the treatment strategies and then used regenerative medicine to help rectify those shortcomings. It definitely reaffirmed that what I had been imagining for my career is in fact possible,” she says.

With a strong interest in neurodegenerative diseases and aging, Ayumi Sakamoto is leaning toward specializing in geriatric medicine. The course confirmed her desire to become a physician and piqued her interest in further exploring regenerative medicine in the context of neurodegeneration.

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Ayumi Sakamota

“Learning about the various cutting-edge techniques and procedures in regenerative medicine gave me a valuable insight into the future of patient care. Hearing about the tremendously positive patient experiences with regenerative treatments has inspired me to continue learning more about the field and motivates me to become a physician who is able to utilize these therapies for my future patients,” she says.

The Mayo Clinic Regenerative Medicine and Surgery Course is a collaboration between the Center for Regenerative Medicine and the Mayo Clinic College of Medicine and Science. Open to students at Mayo Clinic and beyond, this year’s course included students from University College of London, University of Belgrade and the National Institutes of Health Alliance for Regenerative Rehabilitation Research & Training, which included students from Oxford University and Creighton University.

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Mon, Jun 29 6:00am · Research grants aim to advance regenerative medicine toward the practice

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Reprogramming human cells to correct blood disorders such as sickle cell disease, activation of a regenerative pathway to treat liver failure and strategies for skeletal regeneration in patients with brittle bone disease are examples of Mayo Clinic research to be funded through new grants from Regenerative Medicine Minnesota. 

Regenerative Medicine Minnesota, a statewide bipartisan initiative, seeks to advance regenerative science and build the health care of the future. Regenerative Medicine Minnesota awards $4.35 million in grants every year with emphasis on innovation across the regenerative medicine spectrum. The initiative seeks to transform the focus of medicine from treating disease to building health in order to provide Minnesotans with safe new options for their health care. Since its inception in 2014, Regenerative Medicine Minnesota has awarded more than 170 grants totaling $26 million.

In the latest funding cycle, Regenerative Medicine Minnesota awarded seven discovery and translational science awards to Mayo Clinic researchers.


Discovery Science Awards:

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Patricia Devaux,
Ph.D.

Patricia Devaux, Ph.D., $249,998 for Concurrent Gene Editing and Reprogramming of Sickle Cell Disease Fibroblasts using Dual Measles Virus Vectors

This research will test a new technology based on the vaccine strain of the measles virus to determine if it can reprogram human cells to correct genetic defects that lead to blood disorders such as sickle cell disease.

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David Deyle, M.D.

David  Deyle, M.D., $250,000 for Treating Osteogenesis Imperfecta by Inhibiting the PRC2 Complex
The goal of this research is to develop new ways of increasing bone formation for osteogenesis imperfecta, also known as brittle bone disease, using small molecules to inhibit the epigenetic regulator, PCR2.

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Dan Dragomir-Daescu, Ph.D.

Dan  Dragomir-Daescu, Ph.D., $249,112 for Novel Flow Diverter for Hemorrhage Control Using Innovative Magnetic Nanotechnology

The study team will test in pig models the use of novel magnetic technologies, including vascular stent-grafts and bioengineered endothelial cells (cells that line the blood vessels), to see if they can be used together to control hemorrhage and rapidly heal vessels.”

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Martin Rodriguez-Porcel, M.D.

Martin Rodriguez-Porcel, M.D., $250,000 for Understanding the Interaction of Stem Cells and Scaffolds with Host Tissue: Implications of Regenerative Medicine

This study aims to develop a better understanding of the interaction between transplanted stem cells and human tissue.  Specifically, this research seeks to answer whether delivery of biomatrix containing certain chemicals can help transplanted stem cells survive and function in the human body.

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Rory Smoot, M.D.

Rory Smoot, M.D., $250,000 for Activating the Hipp Pathway Effector YAP to Augment Liver Regeneration

The goal of this research is to improve liver function in patients with liver failure. The research team will test whether a specific drug treatment can activate a regenerative pathway and speed liver regeneration.


Translational Science Awards:

Terry Burns, M.D., Ph.D., $250,000 for Human Glial Progrenitor Cells for Radiation-Induced Brain Injury

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Terry Burns, M.D., Ph.D.

This study seeks new solutions for memory and functional impairment caused by radiation to kill brain tumors. Researchers will test in brain models the safety of transplanted stem cells capable of replacing myelin.  Myelin is a substance that coats and protects nerves and improves neurological function.

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Steven Moran, M.D.

Steven Moran, M.D., $250,000 for Regenerative Strategy for Volumetric Muscle Loss and Functional Recovery

This study seeks new regenerative therapeutics for restoring muscle volume and muscle function after traumatic injury or surgery.

Regenerative Medicine Minnesota awarded 13 grants statewide out of 64 applicants in 2020 to advance clinical trials, discovery science, translational science and biobusiness. Funding awarded in 2020 will run through 2022. Regenerative Medicine Minnesota grants are open to all Minnesota-based institutions.

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Tue, Jun 23 6:00am · Harnessing the body's ability to heal

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Researchers at Mayo Clinic are studying ways to engineer human-like tissue to bolster the body’s ability to heal itself. Scientists in the Regenerative Medicine Biomaterials and Biomolecules Lab have engineered biomaterials that could regenerate tissue capable of restoring injured nerves and bones.

They’ve discovered that biomaterials derived from polymers are biodegradable. When used along with growth factors to form scaffolds, these materials are capable of recruiting cells that grow into replacement nerves and bones. Scaffolds are devices that assist in creating tissue. As the new tissue develops, synthetic materials gradually decompose, leaving no trace of its existence in the body. 

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Lichun Lu, Ph.D.

“The hypothesis for this work is that these biomaterials will be able to function as scaffolding material for the cells to attach to once they are in the human body, so they can support tissue regeneration. At the same time, they will degrade in a controlled fashion and will disappear at the end of the process and leave completely natural living tissue in place,” says Lichun Lu, Ph.D., a professor of Biomedical Engineering and Orthopedics in the Biomaterials and Biomolecules Lab.

With support from the Center for Regenerative Medicine, Dr. Lu leads a team of researchers that are developing biomaterials compatible with the human body. Those materials, researchers found, can be manipulated to perform many different functions. Some examples are a synthetic nerve scaffold with the ability to conduct electrical signals from the brain and a manmade bone scaffold porous enough to integrate new blood vessels.

“We have been developing more sophisticated, multifunctional biomaterials that can interact with the cells for tissue generation. These materials offer multiple functions that are similar to the natural environment of the body. They support cell attachment, proliferation and tissue growth,” says Lu.

Another objective of this research is to improve drug delivery in the body —a key role that tissue plays in good health.

Nerve regeneration        

Millions of Americans suffer from peripheral nerve damage, a disorder that hampers daily activities like walking, talking and holding things. Dr. Lu’s team has developed biomaterials to function as a tube scaffold that attaches to damaged nerves, activating tissue regeneration.

The team hopes that one day this tissue regeneration strategy could also be used to restore electrical signals between the brain and the rest of the body in people with spinal cord injuries.

“We have developed multi-channel tubes that can be put in the injured part of the spine to restore electrical signal and recreate the functions the patients lost,” says Dr. Lu.

Peripheral nerve tube scaffolds are currently being tested in human safety studies.

Bone regeneration

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Xifeng Liu, Ph.D.

Disease or trauma can cause bone damage too great for the human body to heal on its own. Dr. Lu’s team is researching ways to engineer scaffolds that unleash the body’s ability to recreate tissue to replace missing, diseased or dead bone cells. The team’s solution:  biodegradable scaffolds that could provide an alternative to manmade devices that sometimes fail or cause infections. 

“We hope to develop a bone scaffold that is anti-inflammatory and bacteria resistant,” says Xifeng Liu, Ph.D., a researcher within the Biomaterials and Biomolecules Lab. “In addition, we can engineer scaffolds that recruit nearby stem cells to generate tissue and speed up the bone regeneration process.”

The team is studying whether this type of bone regeneration could be an alternative to the metal or non-degradable polymer cages used in spinal fusion surgery.  However, that solution could take many more years of research. The team is currently testing scaffolds in large animal studies and hopes to advance the research to human safety studies within five to 10 years.

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This article originally appeared on the Center for Regenerative Medicine blog.

Tue, Jun 16 6:00am · Focus on women's health: Regenerative approaches to stress and fecal incontinence

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Mayo Clinic is taking a regenerative approach to women’s healthcare to provide new therapeutic options for common conditions that standard treatments don’t fully address. One key area of focus is pelvic floor injury that leads to stress incontinence, a widespread and often embarrassing problem affecting some 18 million women, according to the National Association for Continence.

With support from the Mayo Clinic Center for Regenerative Medicine, researchers are probing ways to direct cells to grow new skeletal muscle and restore the body’s ability to control the release of urine and stool.

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Emanuel Trabuco, M.D.

“These are clearly embarrassing situations for our patients, and I believe that often there’s an under representation of women who deal with this. For every patient I have in my office, there’s probably another 5 or 10 who are not coming in because she’s embarrassed to talk about it,” says Emanuel Trabuco, M.D., a urogynecologist at Mayo Clinic.

Life events unique to women such as childbirth, pregnancy and menopause may injure and weaken sphincter muscles surrounding the urethra — the tube through which urine passes out of the body. That can lead to involuntary leaking of urine, particularly when a woman laughs, coughs or sneezes.

Since the late 1990’s, the standard surgical treatment for stress incontinence has been a polypropylene mesh sling implant that supports the urethra. However, even with the sling, some women still experience involuntary leakage. Mayo Clinic researchers are seeking regenerative solutions that would bolster standard treatments and provide new therapeutic choices.

The research

Mayo Clinic researchers are investigating the use of purified exosomal products (PEP) to grow skeletal muscles that could strengthen the pelvic floor. PEP is a cell-free product developed at Mayo Clinic that can be used right at the hospital without the need to grow cells in a lab. PEP contains molecules that direct stem cells to grow and make new muscle, thereby repairing areas of injury. Researchers discovered that PEP could repair the injured urethral sphincter muscle and re-establish pre-injury pressures using an animal model. The histological evaluation showed new muscle tissue and less inflammation at the site of the injury site. They hope that these findings could be translated into a new treatment to control stress incontinence in humans.

“If this works, this would be the first time we’ve been able to improve muscle function as an alternative to treating stress incontinence,” says Dr. Trabuco. “In the past, the only incontinence treatments have been procedures like a sling that establish support underneath the urethra. This would also provide an alternative treatment for women who had a sling but still suffer from slight urinary leakage.”

Fecal incontinence

During child birth, up to 25% of women injure the anal sphincter, a group of muscles that maintains fecal continence when contracted. Despite suture repair of the anal sphincter, some women fail to restore muscle connections and function due to infections or scarring. This results in fecal incontinence symptoms. 

“Studies show up to 88% of women still had defects in the anal sphincter after the suture repair.  It seems that the anal sphincter repair at the time of delivery is not working for a lot of women.  As a result, many patients seek help for fecal incontinence many years after delivery,” says Dr. Trabuco.

Ideally, the optimal time to re-establish function is at the time of delivery. In pilot studies, researchers repaired the anal sphincter with suture while adding PEP to the repair. Similar to their studies on urinary incontinence, researchers showed that sphincter repair with PEP improved muscle healing and strength. These findings gives them hope that new treatment options for fecal incontinence may be on the horizon.

Researchers are seeking to test the purified exosomal products in humans in a phase I clinical trial in humans before then end of 2020.

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The Center for Regenerative Medicine recognizes Michael S. and Mary Sue Shannon for their generosity and support in advancing regenerative women’s health research.

This article originally appeared on the Mayo Clinic Center for Regenerative Medicine blog.

Thu, Jun 11 6:00am · Seeking a regenerative therapy for chronic dry mouth

Mayo Clinic researchers are seeking a regenerative therapy for a vexing problem, particularly among cancer patients. How can medical providers treat a condition in which the mouth is so parched that it has an incessant feeling of a cotton lining? Xerostomia, also known as chronic dry mouth, is an agonizing side effect of injury to the salivary glands. While it is most common after radiation treatment for head and neck cancer, it also afflicts people with diabetes, stroke, Alzheimer’s disease and HIV/AIDS.

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Jeffrey Janus, M.D.

“Dry mouth is something that when you have a life threatening illness, at first may not seem like a big deal. However, this condition can extend long after radiation treatments are complete. It’s probably the top concern I have from head and neck cancer patients. Unfortunately, there aren’t many therapeutics available commercially for these patients,” says Jeffrey Janus, M.D., an Ear, Nose and Throat specialist at Mayo Clinic in Florida.

Currently there is only supportive care —  no cure — for the decrease in saliva that comes from xerostomia. Besides being uncomfortable, chronic dry mouth can lead to difficulties with chewing, tasting, speaking and swallowing. It can also cause tooth decay.

Mayo Clinic Center for Regenerative Medicine, Department of Laboratory Medicine and Pathology and Department of Otolaryngology are collaborating on ways to address the unmet needs of these patients.

The question investigators are seeking to answer is whether the body’s healing abilities could be unleashed to restore natural lubrication of salivary glands. The research will focus on the regenerative abilities of epithelial cells found within many glands in the body, including salivary, mammary and prostate glands. They hope to discover whether epithelial cells could be tapped to regenerate salivary gland tissue to produce natural saliva.

Building on existing research

Previous studies showing epithelial cells purified from mammary glands could regenerate functionally-intact mammary glands piqued the interest of the research team.  Could the same concept be applied to heal and restore saliva in salivary glands? Their research will build on this existing body of knowledge.

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Nagarajan Kannan, Ph.D.

“In many ways salivary glands resemble mammary glands. As early as 2006, it was shown that a single transplantable mammary cell could regenerate highly complex lactational structure. That was the genesis of the concept that glands represent epithelial stem cells and that we might be able to harness these rare cells for treatment of dry mouth,” says Nagarajan Kannan, Ph.D., a scientist with the Department of Laboratory Medicine and Pathology and head of the Stem Cell and Cancer Biology Lab at Mayo Clinic.

To validate this theory, the team has identified a few hurdles to overcome that could stall the research.

First, they need robust human tissue samples to test their theory. They’ve planned to establish a biobank of the three different types of human salivary glands with samples from consenting men and women. Second, they are developing robust methods to isolate and study epithelial cells from salivary glands. Third, they need a model in which to investigate whether those cells could regenerate human salivary tissue. To address this issue, they will study epithelial cells in immune-deficient mice that have been biologically engineered to mimic injured human salivary glands.

“Using this model, we can now start testing how the salivary cells permanently engraft and regenerate into salivary structure and restore saliva. Our model measures how saliva production drops and holds at a decreased level. It is the best model available for studying how human salivary samples perform over time,” says Dr. Kannan.

No specific date has been set for advancing this concept into human clinical trials. However, Dr. Kannan and Dr. Janus are hoping the preclinical studies will lay the foundation for early safety studies within the next year or two.

“I’m hopeful that if we can show this is safe and effective, we can immediately transition into using this regenerative procedure using silo endoscopy, which is like endoscopy of the salivary glands, to implant these cells in early clinical trials,” says Dr. Janus.

Accelerating the findings toward clinical practice is a priority. The team will not only work across departments at Mayo Clinic, but will also collaborate with experts outside of Mayo Clinic to move the research forward as quickly as possible.

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This article originally appeared on the Center for Regenerative Medicine blog.

Wed, Jun 3 6:00am · Regenerative approaches could foster healing from COVID-19

a young white man wearing glasses and carrying a backpack on a subway train, looking sick or ill and wearing a face mask to limit transfer of germs and infectious diseases

Regenerative Medicine aims not only to repair or restore the function of cells, tissues or organs, but also the whole person. The latter is particularly important amid the COVID-19 pandemic. Regenerative approaches draw on the body’s natural abilities to heal, focus on establishing the healing environments and building new, healthy ways of functioning. These aspects of regenerative medicine may nurture healing in people who’ve contracted the virus, those who treat it and the broader community whose lives have suddenly been changed by the pandemic.

Creating safe, trusting environments

When people are diagnosed with COVID-19, their illness may go beyond physical afflictions to a breakdown of the mind and spirit. Some coronavirus patients are immediately isolated, separating them from the people they love. That may trigger confusion, fear, anxiety and mistrust.

In a normal health care environment, patients might be soothed by welcoming faces and warm touches of medical professionals. But in the new world of a virus to which no one is immune, caregivers must wear personal protective equipment for their own safety. The face masks that allow patient and clinician to come together safely may also be a barrier that increases isolation and fear.

Victor Montori, M.D.

“It creates a new population of people who are traumatized,” says Victor Montori, M.D., an endocrinologist at Mayo Clinic and expert leader for the Mayo Clinic Center for Regenerative Medicine. “This trauma is a response to the difficult and unbearable aspects of COVID-19. It manifests itself as emotional and physical responses. In addition to fostering conditions to prevent trauma, the regenerative approach to healing in this case might mean that as people recover from COVID, they go on to receive additional care from psychologists and social workers that would help them build trust to overcome their trauma.”

Health care professionals who are on the forefront of care may themselves suffer trauma, particularly if they witness death, see colleagues become ill or have to make difficult decisions about prioritizing care.

Dr. Montori says creating a safe, trusting environment is a good antidote to trauma. He suggests an effective platform for healing may be trauma-informed care, a way to prevent and care for people with post-traumatic stress disorder. Trauma-informed care creates a safe environment in which trauma is noticed and a caring response developed that fosters recovery. The emphasis for caregivers is on organizational safety, trustworthiness, cultural sensitivity and collaboration.

For the patient, trauma-informed care seeks to build coping skills and foster resiliency through:

  • Managing emotions
  • Connecting with others
  • Finding hope, purpose and meaning

“To build back health, they’ll need to rehab their muscles and ability to breathe. Equally important is to regenerate the psyche and the way they trust and feel safe in the world.  Teamwork across clinical disciplines and collaboration with community partners is necessary, therefore, to work with affected patients and clinicians, so they can be supported in their healing,” says Dr. Montori.

Tapping the human mind to heal

Emotional trauma may extend beyond patients suffering with COVID-19 and those on the front lines of treating it, according to Craig Sawchuk, Ph.D., L.P., chair of Mayo Clinic Division of Integrated Behavioral Health. Fear, anxiety and stress also may be prevalent in otherwise healthy people who are overwhelmed by the societal and economic fallout of the pandemic. Psychological healing may be needed among people who fear contracting COVID-19 as well as those experiencing social isolation, job loss or financial pressures.

Craig Sawchuk, Ph.D., L.P.

“The amount of uncertainty related to COVID-19 is unprecedented,” says Dr. Sawchuk. “There has been a complete disruption of day-to-day routines. No one is certain how long it is going to last. We see stress-related problems like sleep disruption, fatigue, physical tension, irritability and worry.”  

One key way to foster psychological healing, Dr. Sawchuk says, is by taking charge of things you can control and letting go of things you can’t.

“It is important to come to a level of acceptance with the situation. That doesn’t mean you have to be OK with it,” says Dr. Sawchuk. “But, we must be aware some people will have trouble and get stuck in conditions similar to post traumatic stress disorder or significant depression. They may need ongoing treatment.”

Dr. Sawchuk recommends several pathways to healing:

  • Limiting exposure to COVID-19 related news.
  • Finding support from family, faith and friends.
  • Developing a structured daily routine that includes proper nutrition, exercise and sleep.
  • Exploring self-help resources such as mental health apps that offer coaching for stress management, worry management, positive attitude and goal setting. Psyberguide.com is a free service that provides ratings of mental health apps.
  • Seeking face-to-face counseling, including behavioral therapy and other coping strategies.
  • Making an appointment for psychiatric evaluation or medication management.

In a world that has changed dramatically in just three to six weeks of time, healing mind, body and spirit may take time.

“It’s not like a light switch in which we can instantly turn back on the economy or return to our normal social routine. It’s probably going to be more like a gradual dimmer switch. For a while, people are going to feel like they are living life walking in a minefield. They’re likely to be extra cautious about reclaiming their usual activities,” Dr. Sawchuk says.

Rebuilding health

The regenerative medicine notion of building something new to restore health may also be applied to COVID-19 healing.

Ian Hargraves, Ph.D.

“Already, we see a lot of building and creating in the way that people live with COVID-19,” according to Ian Hargraves, Ph.D., a scientist and author of a regenerative medicine position paper. “People are creating new types of social interactions based on social distancing, and they are remaking schooling through online learning. They are redefining work and family life. People are making masks and creating new senses of who they are and what their world is.”

Those recovering from the trauma of COVID-19 may not be able to go back to the way things were before the pandemic, Dr. Hargraves says. For example, they may need to continue the practice of social distancing or may need to take their temperature daily. Although the virus was thrust upon hundreds of thousands of people, those who care for people with COVID-19 can help with healing by supporting people as they rebuild their lives, relationships and outlook, he adds.

Dr. Sawchuk predicts that personal and community healing will eventually come when COVID-19 infections, hospitalizations and deaths subside. Until that time, a regenerative approach of creating an environment of trust to ease trauma, tapping the human psyche for healing and focusing on creating something new may be the catalyst for recovery and preparation for a post-COVID-19 world.

The Mayo Clinic Center for Regenerative Medicine supports programs and practices that transform the focus of health care from treating disease to one of restoring health and healing.

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Thu, May 21 6:00am · A discovery step toward cell replacement therapy for diabetes

In what could be a step toward cell replacement therapy for diabetes, Mayo Clinic researchers have discovered how to manufacture cells capable of generating a hormone that regulates low blood sugar. Quinn Peterson, Ph.D. and his team have developed a new method of mass producing a cell product containing the hormone glucagon that is capable of protecting against hypoglycemia in animal models. Dr. Peterson’s research is published in Nature Communications.

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Quinn Peterson, Ph.D.

“We now have the ability to manufacture large quantities of an important cell type that is necessary to prevent hypoglycemia and regulate blood glucose in patients with diabetes. Generating pancreatic cell types from renewable sources holds promise for cell replacement therapies for diabetes,” says Dr. Peterson, principal investigator.

Alpha cells in the pancreas produce glucagon, which is released to correct low blood sugar levels. However, in diabetes these alpha cells become dysfunctional, leaving patients susceptible to hypoglycemia (low blood sugar). Left untreated, hypoglycemia can cause a patient to fall into a coma and die.

Biomanufacturing cells

The new cell product is human tissue derived from pluripotent stem cells, which have the capacity to self-renew and convert into alpha cells containing glucagon. When transplanted into animals, Dr. Peterson’s team discovered, these cells defended against hypoglycemia. Researchers hope someday these biomanufactured cells could restore cell function lost to diabetes.

With capabilities from the Center for Regenerative Medicine, including the Center’s Bio trust and the Center’s Process Development Laboratory, Mayo Clinic has the ability to ramp up large scale manufacturing of cells right on site. Quality and regulatory teams are working on new standard operating procedures that provide the foundation for current Good Manufacturing Practices needed to comply with Food and Drug Administration regulations. That could eventually pave the way for clinical trials geared toward exploring the safety and effectiveness of manufactured cells as a treatment for Type 1 diabetes.

“If successfully introduced into clinical use, these cells could dramatically change patient care for diabetes.  Rather than rely on routine blood checks to prevent hypoglycemia and emergency room interventions to treat severe hypoglycemia, in the future, patients may be able to receive a transplant of living medicine that will both monitor blood glucose levels and administer corrective doses of glucagon,” says Dr. Peterson.

Dr. Peterson estimates that the first test of these cells in human clinical trials could take place by 2022.

This work was supported in part by benefactor gifts to the Mayo Clinic Center for Regenerative Medicine, including the Stephen and Barbara Slaggie Family, J.W. Kieckhefer Foundation and the Khalifa Bin Zayed Al Nahyan Foundation. Colleagues at Harvard University and University of Gothenburg participated in this study. 

This article originally ran on the Center for Regenerative Medicine blog.

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Wed, Apr 22 6:00am · Regenerating diseased bones

Kendall Koens’ life is a dramatic reversal from what it was in 2006. Late stage cancer left him in a coma and on a ventilator fighting for survival. Aggressive chemotherapy was saving his life but slowly and silently destroying his hips joints. The financial planner from Rochester, Minnesota, faced crippling pain typical of someone more than twice his age until a regenerative surgery pioneered at Mayo Clinic restored life to his bones.

Cancer leads to bone disorder

Mr. Koens was 26 years old when doctors discovered a grapefruit size cancerous tumor in his chest. Chemotherapy and heavy steroids fought the germ cell cancer but left him with lung damage and a rare side effect that surfaced four years later. He developed avascular necrosis  of the hip, a condition in which blood stops flowing to the top of the hip joint known as the femoral head. Avascular necrosis, also called osteonecrosis, causes bone cells to die. Tiny fractures that result sometimes lead to collapse of the joint.

Kendall Koens

“I was facing the possibility of needing a hip replacement. It was pretty concerning from a long term point of view.” says Kendall Koens. “Hip replacements only last so long. Being young, I knew that if I had a hip replacement, I might need a second or maybe even a third hip surgery over the course of my lifetime.”

Koens’ primary physician referred him to Rafael Sierra, M.D., a Mayo Clinic orthopedic surgeon who specializes in treating disorders of the hip and often with the newest regenerative treatments. 

Rafael Sierra, M.D.

“Avascular necrosis in the past has been described as one of the unsolved mysteries of orthopedics, because we really don’t have a way,  once it has started , of halting the process of the dying bone or even changing the natural history unless you catch it early,” says Dr. Sierra. “Without treatment, up to 90 percent of all people with this condition will need a hip replacement.”

Dr. Sierra recommended surgery that taps into the body’s own healing powers to restore dead bone tissue. Mayo Clinic was one of the first medical centers in the United States to offer this regenerative treatment. It’s a hip decompression surgery in which a small hole is drilled in the outside of the bone to access the femoral head to release pressure with the hopes of improving the blood flow to the damaged bone. This procedure is further fostered by a regenerative biotherapy.

“After the decompression, we take bone marrow from the pelvis that has the stem cells. We spin it in a centrifuge that separates red blood cells from the mononuclear cells that play a key role in healing.  These mononuclear cells are then injected back into the hip where they act as healing agents,” says Dr. Sierra.  “It is done as an outpatient procedure that takes about an hour. Generally there is very little pain and very low morbidity for the majority of patients.”

This type of modern hip decompression, with injection of bone marrow concentrate  and bone graft done within the constraints of the operating room, is an approved therapy. The goal is to avoid or delay hip replacement for patients like Kendall Koens whose osteonecrosis is still in an early, treatable stage.  Recovery time varies based on how far the bone decay has advanced prior to treatment. If caught early, recovery may be quicker than a hip replacement, but in later stages if surgery is performed to save the femoral head, recovery could take more time. 

Although this was a new procedure, Koens decided it was worth the risk to avoid a hip replacement. In 2010, he became one of the first patients at Mayo Clinic to have the hip decompression surgery.

“After meeting with Dr. Sierra and hearing about this surgery, we were so excited and full of hope. At the time it felt like an unbelievable opportunity. I decided to have it done and take it a day at a time.  Here it is a decade later, and I’m doing well,” he says.

Koens’ life continues to take positive turns. His cancer is in remission. He lives an active lifestyle.  Though cancer left him unable to have his own children, he and his wife became parents two years ago to two adopted daughters. He regularly takes walks with his family and has no problem chasing after two energetic preschoolers.

The Koens family

“I live a very normal life and don’t have any pain. I’m so grateful that I haven’t had to go through a life of hip replacements. I can’t imagine what that would mean for activity restrictions. My life would be so much different,” Koens says.  “Dr. Sierra told me to avoid running marathons and playing sports like basketball that have a heavy impact on the hips. I’m not a marathon runner anyway, so this recommendation didn’t change the course of my life.”

Helping hundreds avoid hip replacement

Dr. Sierra has performed as many as 300 hip decompression surgeries. Many of the patients are younger people like Kendall Koens who wanted an alternative to a total hip replacement.  

“Hip replacements are common and we love doing them.  However, if we can avoid them, it is in the patient’s best interest long term.

Dr. Sierra’s practice is based on scientific evidence. He regularly conducts research to improve surgery to treat avascular hip necrosis, an example of science-driven practice advancement at Mayo Clinic.

Mayo Clinic Center for Regenerative Medicine supports research and practice to advance therapies like modern hip decompression surgery that restore form and function to diseased cells, tissue or organs.

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Links to Dr. Sierra’s research:

This story first appeared on the Center for Regenerative Medicine blog.

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