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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Tue, Jun 25 6:00am · Mayo Clinic course addresses education gap

Regenerative medicine is redefining clinical care—going beyond disease symptom management to addressing the underlying cause of disease to restore health. Regenerative care is expected to represent 10% of all health care in the next decade. Yet, education in regenerative medicine lags behind scientific and clinical advances. This threatens to leave physicians-in-training ill-equipped to address changing needs in patient care.

In a recently published paper, Mayo Clinic educators lay out the Mayo Clinic’s Regenerative Medicine and Surgery course, supported in part by Regenerative Medicine Minnesota, as a solution to bridge this recognized knowledge gap through an innovative curriculum and transdisciplinary training. The course serves an educational imperative to enhance the practitioners’ literacy, competency and overall proficiency in new knowledge and specialized skillsets mandated by the rapidly evolving regenerative era.

Fundamental principles of the “regenerative medicine and surgery course” curriculum are introduced early in medical school training, and expanded in residency and clinical fellowship, allowing for core proficiency to develop into advanced expertise of the next-generation specialized workforce.
Fundamental principles of the “regenerative medicine and surgery course” curriculum are introduced early in medical school training, and expanded in residency and clinical fellowship, allowing for core proficiency to develop into advanced expertise of the next-generation specialized workforce.

“This curriculum was collectively developed by the Center for Regenerative Medicine experts in order to build the foundation for a specialized workforce equipped with skills to distinguish safe and valid regenerative options, as well as carry out regenerative care,” says Saranya Wyles, M.D., Ph.D., course director. “It emphasizes the need for regenerative medicine to be introduced early and longitudinally during medical education in order to develop a proficient physician cohort that can advise patients to distinguish validated and robustly regulated treatments.”  

This curriculum offers a comprehensive educational experience that encompasses discovery, development and delivery of next-generation patient management, while spanning technologies across relevant medical and surgical specialties. It is offered across medical training as a first-year medical student elective, fourth-year medical student clinical elective and residency selective.

“The Regenerative Medicine and Surgery course offers a patient-centric curriculum that involves patients previously enrolled in clinical trials, as well as simulated patient experiences,” says Richard Hayden, M.D., director of education for the Center for Regenerative Medicine. “This educational format is unique to Mayo Clinic, providing an educational prototype in regenerative training.”

Educators at the Center for Regenerative Medicine are continuously evolving this ‘from the patient to the patient’ training platform sharing globally the growing experience.

“Over the five-year developmental period of this course, the curriculum increased student literacy in regenerative medicine and inspired a sizeable percentage of participants to pursue expanded degree programs in the area of regenerative science and associated medical applications,” says Dr. Wyles.

In addition to the Regenerative Medicine and Surgery course, offered twice yearly, the Center for Regenerative Medicine offers education and training on regenerative medicine techniques, advances and application for learners at all levels of expertise, from online modules available to the general public to specialized training for current and future medical professionals. A recent blog post highlighted the 2019 Regenerative Medicine and Surgery course.

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Tue, Jun 11 6:00am · Regenerative medicine training for the future workforce

Participants of the 2019 Regenerative Medicine and Surgery Selective at Mayo Clinic.
2019 Regenerative Medicine and Surgery Selective

Bringing regenerative medicine to more patients requires highly skilled medical providers. During a recent weeklong educational course, 42 medical and graduate students were immersed in regenerative medicine at Mayo Clinic. The Regenerative Medicine and Surgery Selective introduces students to regenerative medicine and surgery by engaging students in the fundamental principles and cutting-edge applications of regenerative medicine within clinical practice. This knowledge will enable them to  advance the use of regenerative therapies in all areas of medical practice.

“The Regenerative Medicine and Surgery Selective gives us the opportunity to provide students with a hands-on experience of regenerative medicine at Mayo Clinic,” says Saranya Wyles, M.D., Ph.D., course director. “The students participate in interactive lectures, laboratory demonstrations, clinical highlights, and patient interactions during the course.”

Eric Grewal

Learners of all
levels of expertise and education came to enhance their knowledge of
regenerative medicine and to experience Mayo’s patient-centered, team-based approach
that spans the spectrum of discovery science, translational research, and
clinical application.

For Mayo Clinic
Alix School of Medicine first-year medical student, Eric Grewal,
who is studying immunology, experiencing the translation from research in the
lab to the application of regenerative medicine in a clinical setting was the highpoint
of the week.

“We’re just beginning to understand the capabilities of
immunotherapy and how a patient’s own cells can be used to heal them,” says
Grewal. “I hope to one day apply what I’ve learned during this course, and
throughout my training, to develop the next generation of immunotherapies for
cancer.”

Immunotherapy is just one area using regenerative medicine.
The field spans all medical specialties, from prenatal surgery to cardiology to
neurology, and beyond.

Maria Astudillo Potes

Maria Astudillo
Potes, in Mayo Clinic’s Postbaccalaureate Program, had a personal reason for
attending the Regenerative Medicine and Surgery Selective course. She became
interested in regenerative medicine for neurological disorders after her grandfather
suffered a spinal cord injury in 2016.

 “My grandfather’s
injury sparked my interest in stem cells and regenerative medicine,” says Astudillo
Potes. “This course helped me to understand how the work in the lab is being
translated and applied to patient care across disciplines.” 

Astudillo Potes is starting her M.D., Ph.D., training this
summer, where she hopes to study the role of stem cell therapies for spinal
cord injuries. 

The Regenerative Medicine and Surgery Selective is offered twice yearly by Mayo Clinic Alix School of Medicine and the Center for Regenerative Medicine, and is co-sponsored by Regenerative Medicine Minnesota.

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About Regenerative Medicine Education at Mayo Clinic
The Center for Regenerative Medicine offers education and training on regenerative medicine techniques, advances and application for learners at all levels of expertise, from online modules available to the general public to specialized training for current and future medical professionals. Additionally, the center disseminates knowledge about regenerative medicine through conferences and symposiums and expands learning opportunities through strategic education collaborations. Richard Hayden, M.D., is the director of education for the Center for Regenerative Medicine.

There are five schools in the Mayo Clinic College of Medicine and Science:

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

Thu, May 30 6:00am · Mayo Clinic orthopedist shares perspective on regenerative medicine

Regenerative
science has advanced next-generation technologies from the research bench to potential
clinical care options. But in the rigorous development of patient therapies, it
is critical to validate the safety and efficacy of regenerative solutions.

Photo of  Dr. Shane Shapiro
Shane Shapiro, M.D.

Shane Shapiro, M.D., medical director of the Regenerative Medicine Therapeutics Suites on Mayo Clinic’s Florida campus, encourages patients to educate themselves to make informed choices about their care. The Suites deliver regenerative therapies for a variety of musculoskeletal injuries and conditions and for dermatologic applications.

“In general, regenerative medicine is regarded with much hope, but with that has come much hype,” says Dr. Shapiro. “Treatments should always emphasize the evidenced-based standard of care predicated on best practices and validated science.”

Dr.
Shapiro offers three considerations for musculoskeletal regenerative care:

1. Orthobiologics are a new regenerative
treatment option.

Most
patients with torn ligaments, pulled muscles, joint pain and injured tendons
heal with standard therapies. However routine treatment with gentle pain
relievers and physical therapy is not effective for all patients with chronic injuries.
And for patients with degenerative diseases, such as arthritis, only palliative
care is available.

In
these cases, orthobiologics can bridge the treatment gap for patients who do
not respond to standard treatment but are not ready for joint replacement
surgery. Orthobiologics use biological agents with growth factors to activate
healing. For example, there are therapies that use platelets that then are injected
into the area of the patient’s injury.

“For
people who need regular treatment, orthobiologics, like platelet-rich plasma spun
from a patient’s own blood, often enable people to live active lives until
there is another option for them like joint replacement,” says Dr.
Shapiro.

A second option that is relatively new to clinical practice is bone marrow aspirate concentrate injections. Bone marrow aspirate is concentrated bone marrow that contains stem cell and many other cells that assist with healing.

2. Regenerative therapies are not a
miracle cure.

“Regenerative
therapies are increasingly being considered to supplement the spectrum of traditional
treatments,” says Dr. Shapiro.

Before Mayo Clinic patients receive any regenerative treatments, they are referred to the Regenerative Medicine Consult Service, where they receive education and are offered access to the appropriate Mayo Clinic specialist team.

3. Regenerative medicine is still
evolving.

Regenerative
medicine is an emerging field. Physician-scientists are learning and advancing
the science every day. Mayo Clinic performs regenerative therapies that have
been studied rigorously over many years.

“There
are 10 randomized controlled trials over 10 years to support the use of
platelet-rich plasma in arthritis to relieve pain. There are 18 randomized
controlled trials that overall provide scientific evidence supporting the use
of platelet-rich plasma in rotator cuff surgery to help with healing,”
says Dr. Shapiro

In
addition, Mayo Clinic is the first academic medical center to conduct a
randomized controlled trial on bone marrow aspirate concentrate.

There
is still much to learn, Dr. Shapiro says, and physicians are continually performing
research and applying knowledge to refine the procedures.

“We
continue to study and refine our experience,” says Dr. Shapiro.

Learn
more about Dr. Shapiro’s research in these journal articles:

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Wed, Feb 27 6:00am · Leading the charge in regenerative medicine

Regenerative medicine therapies aim to rebuild and restore health to patients challenged by chronic conditions and degenerative diseases. Despite advances in the field, much of the science is still in early research phases, meaning that many treatments haven’t been proven safe and effective for humans as standard-of-care therapies yet. Because the scientific process is long, and there is great hope for regenerative therapies as treatments for a wide variety of diseases, the FDA has created streamlined pathways to help get regenerative options to patients more quickly. In fact, the FDA recently announced that it will greatly expand its regenerative therapies review process.

The hope in regenerative therapies has also led to “hype” surrounding this field of medicine. This is especially true for the case of stem cell therapies, which are often marketed to the public as cure-alls for a variety of medical conditions. Unfortunately, many of these for-profit clinics do not have scientific evidence to back up their claims, and many patients pay out-of-pocket for treatments that may not have any benefit (and, more concerning, may produce serious harms).

“It is our responsibility to make sure that we get safe and ethical products to our patients,” says Zubin Master, Ph.D., an associate consultant in the Biomedical Ethics Research Program at Mayo Clinic. “Our early experience in this process will pay off when more of these therapies become available through legal and approved pathways, and we translate them into the clinical practice for a number of specialties.”

In the Mayo Clinic Center for Regenerative Medicine, several steps have been taken to ensure that regenerative therapies are translated to the public responsibly. In a recently published paper, researchers outline three major ways in which they are innovating in order to best serve the needs of patients. The goals are to positively impact patient education and navigation, provide an example of an interdisciplinary clinical space that can be used for regenerative medicine research and treatment, and lastly, track the outcomes of patients.

The first area of innovation is the Regenerative Medicine Consult Service, a free service offered to patients who would like to know more about regenerative options for a particular medical condition. Patients can call in to speak with a consultant who can give information on the state of stem cell research, share potential research opportunities, and potentially recommend clinical services.

The  Regenerative Medicine Therapeutic Suites at Mayo Clinic’s Jacksonville campus is another advancement at Mayo Clinic. This clinical space is regulatory-compliant and integrated patient care with laboratory functions. The unique space serves both patients and clinicians, providing a place for multidisciplinary teams to expand current projects in order to deliver individualized regenerative therapies and procedures to patients.

Lastly, the Regenerative Evidence-Based Outcomes Registry was launched in November 2018 and has already logged nearly 200 surveys with information about patient treatments and outcomes. This “real world evidence” will be used in conjunction with other mechanisms, such as clinical trials, to validate therapies for patient use. The platform collects a variety of data, including information about ethical concerns related to patient understanding of stem cell therapies and the difference between research and therapy. This knowledge will provide a more robust source of information in order to advance regenerative therapies and education for patients around stem cells and regenerative medicine.

“Our program is about how we prepare our health care system to utilize these treatments in the future,” says Shane Shapiro, M.D., program director for the Regenerative Medicine Therapeutic Suites and assistant professor of orthopedic surgery. “Cell therapy will be a valuable tool for many conditions, and our health care providers have to be prepared to deploy them.”

— Cambray Smith, research assistant, Biomedical Ethics Research Program

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Wed, Feb 6 6:00am · Mayo Clinic investigators receive research awards from 'Regenerative Medicine Minnesota'

Regenerative Medicine Minnesota (RMM) recently announced the 2019 Regenerative Medicine Minnesota Research Awards. This year’s research grants are aimed at developing better therapies for people with diabetes, cartilage injury, heart disease, cancer, chronic obstructive pulmonary disease, spinal cord injury, neurological disorders, and age-related macular degeneration. The grants are awarded to investigators in the areas of discovery science, translational research and clinical trials. They are effective for a two year period. Seven Mayo Clinic investigators were selected to receive awards.

Mayo Clinic awardees include:

 

Jonathan Finnoff, D.O.
Protein Removal and Purification of Platelet Rich Plasma (PRP2)

Dr. Finnoff, a physical medicine and rehabilitation specialist at Mayo Clinic Sports Medicine, is studying the development of a more effective form of platelet rich plasma (PRP) for musculoskeletal injuries and diseases.  Catabolic factors within the PRP will be removed in an effort to enhance the regenerative potential of the PRP.

 

 

Leigh Griffiths, Ph.D., MRCVS
Saphenous Vein Extracellular Matrix Scaffolds for Use in Coronary Artery Bypass

Dr. Griffiths is a veterinary cardiologist, cardiovascular surgeon and research scientist focused on identifying and overcoming immunological barriers in organ transplantation. His research project aims to develop a safe and effective off-the-shelf vessel replacement material for use in coronary artery bypass graft (CABG) procedures to overcome limitations associated with current approaches.

 

 

LaTonya Hickson, M.D.
Patient-derived Mesenchymal Stromal Cell Therapy in Diabetic Kidney Disease: A Phase I Study

Dr. Hickson, a nephrologist, is researching mesenchymal stromal cell (MSC) transplantation for diabetic kidney disease (DKD) — the most common cause of kidney failure in the United States. The study will assess the safety, tolerability, feasibility and early efficacy signals that relate to response to intra-arterial kidney delivery of patient-derived adipose tissue-derived MSCs in patients with DKD.

 

 

Wenqian Hu, Ph.D.
Killing Cancer Cells by Activating the Cellular Intrinsic Nuclear Loss Program

A current barrier in leukemia treatment is the rise of drug-resistant mutations in the genome of cancer cells, which makes many well-designed cancer drugs ineffective over time. Dr. Hu is researching the development of a novel method of killing leukemia cells by inducing them to expel their nuclei in order to address this issue.

 

 

Mi-Hyeon Jang, Ph.D.
Targeting Adenosine A2A Receptor as a Novel Regenerative Therapy in Improving Chemobrain

Dr. Jang is associate professor of neurologic surgery, and assistant professor of biochemistry and molecular biology. Cognitive dysfunction is a major adverse effect of chemotherapy, severely impacting quality of life for cancer survivors. Dr. Jang is researching whether targeting the adenosine A2A receptor (Adora2a) is an effective regenerative strategy in promoting dendrite spine regeneration and improving chemotherapy-induced cognitive dysfunction. The outcome of her work will provide an etiology of chemotherapy-induced cognitive dysfunction and a novel regenerative strategy for the development of effective therapy.

 

Veena Taneja, Ph.D.
Regenerating Lung Homeostasis to Treat Chronic Obstructive Pulmonary Disease in Humanized Mice

Dr. Taneja, an immunologist, is studying the treatment of emphysema in mice with a novel human oral bacterium (isolated in our laboratory), which is known to be lacking in COPD patients. Because this bacterium are present in healthy individuals, the hope is that this treatment will improve lung function altered by smoking.

 

 

Arthur Warrington, Ph.D.
Improving Remyelination for Spinal Cord Injury

Dr. Warrington is a research scientist and an assistant professor in the Department of Neurology at Mayo Clinic. He has worked to develop human antibodies as drugs to encourage new myelin and to protect brain and spinal cord cells in patients with demyelinating disease. His research will investigate whether a human antibody currently in early stage clinical trial in patients with multiple sclerosis, may benefit patients with spinal cord injuries.

 

In 2014, the Minnesota Legislature created RMM as a joint venture between the University of Minnesota and Mayo Clinic with the goal of establishing infrastructure and supporting research that would bring the benefits of regenerative medicine to the citizens of the state.

Thu, Jan 24 6:00am · Golden era in medicine: Regenerative medicine symposium looks to the future

Business Strategy in Regenerative Medicine panel discussion.

Practice advancements, scientific discoveries, product development and access to care were just a few of the topics featured at the 2018 Mayo Clinic Symposium on Regenerative Medicine and Surgery, held earlier this month in Scottsdale, Ariz.

Over 200 providers, scientists, educators, students, entrepreneurs and patient advocates were in attendance to share knowledge and discuss how science driven advancements in regenerative medicine are increasingly embedded in daily practice and what this means for the future of the field.

“If you think about the advances that are occurring in medicine — in immunotherapy, genomics, big data, artificial intelligence, and in regenerative medicine, there is no doubt that 50-100 years from now this time will be viewed as the golden era in medicine,” says Wyatt Decker, M.D., vice president, Mayo Clinic, and CEO of Mayo Clinic in Arizona. “A time when incredible advances were made and solutions were developed for once unsolvable dilemmas in health care.”

While discoveries and practice advances are being made in bringing regenerative medicine breakthroughs to clinical trials and practice applications, experts are now looking at the future of the regenerative practice and what that means for patient care.

“Although stem therapies are a mainstay of the regenerative medicine practice of today and the future, we also need to think about how to reduce cost and improve therapeutic effectiveness for these and other regenerative therapies,” said Atta Behfar, M.D., Ph.D., a Mayo Clinic cardiologist, who is director of the Van Cleve Cardiac Regenerative Medicine Program and deputy director of translation for the Center for Regenerative Medicine. “Patient access is important in regenerative medicine and how we disseminate regenerative medicine technologies across the world is key.”

Throughout the symposium, Mayo Clinic experts in regenerative medicine highlighted clinical trial breakthroughs and advancements in therapeutic interventions that address diseases and conditions such as cancer, Alzheimer’s disease, spinal-cord injuries and diabetes. Updates on product development and manufacturing, CAR-T cell therapy, and the first patients treated at the Florida Regenerative Medicine Therapeutic Suites were also presented. Over 50 posters in clinical application, regenerative education, and translational science showcasing the next discoveries and innovations in regenerative medicine were presented at the symposium.

“Mayo Clinic is going to be the institution that the world looks to as we incorporate regenerative technologies into the day-to-day medical practice,” says Richard Hayden, M.D., an otolaryngologist, director of education for the Center for Regenerative Medicine, and symposium director. “Mayo has to be in the game to ensure complex patient care needs are met now and in the future.”

Tyler Rolland, Sinibaldo Romero, and Karen Hedin, Ph.D.

Symposium on Regenerative Medicine and Surgery poster session.

Product Development and Manufacturing panel discussion.

 

 

 

 

 

 

 

 

 

Nov 28, 2018 · Stem cells and chronic kidney disease

Millions of Americans have chronic kidney disease. Hundreds of thousands will progress to end stage kidney disease requiring either dialysis or kidney transplant. But research is underway to keep people from reaching that point.

“Our goal is to take a look at how we can repair the diabetic kidney in terms of delaying the rate of progression of kidney failure,” says LaTonya Hickson, M.D., a Mayo Clinic nephrologist.

Dr. Hickson is part of the research team looking at using stem cells to help regenerate failing kidneys.

“We take these cells from our abdominal fat and we can inject them back into the body for them to do good,” says Dr. Hickson. “They basically tell the kidney or other organ systems that are impaired to wake up and get back to work and help heal that organ system.”

While there’s a lot more research ahead, Dr. Hickson is excited about the possibilities.

Listen to the Mayo Clinic Radio Health Minute and learn more about stem cells and chronic kidney disease in the video below:

Nov 19, 2018 · Regenerative medicine is the future for Dr. Amy Lightner

Dr. Lightner was recently honored with the Sherman Emerging Leader Prize for making impressive contributions early in her career and demonstrating strong potential to make an even greater impact in the future. (Photo courtesy of Dark Spark Media.)

Volunteering for a reading program at a children’s hospital led to a career change for Amy Lightner, M.D. As a Stanford University undergraduate, she met a cardiac surgeon who turned her interest to medicine.

“I got to see how medicine and surgical intervention could change a child’s life forever,” says Dr. Lightner. “The research, in parallel, changed lives of thousands, and this combination of clinical practice and translational research was inspiring.”

Today Dr. Lightner is a Mayo Clinic colorectal surgeon, practicing minimally invasive surgical approaches and researching regenerative cellular therapies for some of the most difficult complications of inflammatory bowel disease (IBD). She is recognized as an emerging leader for her achievements in improving surgical outcomes for patients.

Dr. Lightner completed her general surgery residency and two years of full-time research studying stem cell biology in a liver regeneration and immunology laboratory. While she found liver transplantation fascinating, it was while she was finishing her clinical training she turned her focus to IBD and a career in colorectal surgery. IBD is an umbrella term used to describe disorders that involve chronic inflammation of the digestive tract, including ulcerative colitis and Crohn’s disease.

“I would see young patients suffering from chronic bowl disease coming to terms with suffering for the rest of their lives without a known cure,” says Dr. Lightner. “Surgery treated the symptoms but not the disease, and I thought we could do so much better than the current treatment options — we needed to find out how to treat the underlying disease.”

Dr. Lightner immersed herself in a Mayo Clinic fellowship for complex clinical care and stem cell research to treat perianal Crohn’s disease. It was during this time she started to see a connection to stem cells and the therapy for IBD. “This was the time that regenerative medicine was taking off at Mayo and becoming an institutional priority,” says Dr. Lightner. “The timing was perfect.”

For patients with ulcerative colitis, a proctocolectomy, or removal of the colon and rectum, is often a last resort. After a proctocolectomy, a J-pouch surgery is performed to create an internal pouch, eliminating the need for a permanent ostomy bag. However, in about 10 to 15 percent of patients the pouch will fail and they will need a permanent ostomy.

Dr. Lightner offers these patients an alternative. She is among a small group of surgeons across the country that is skilled at pouch reconstruction – giving patients a chance at an ostomy-free life.

While an innovative physician who is an expert at reconstructive pouch surgery, Dr. Lightner wants to see fewer IBD surgeries. She is currently researching innovative cellular, non-surgical therapies.

“Regenerative medicine with novel cellular and acellular therapies is the future of medicine,” says Dr. Lightner. “I want to change the way we think of treating IBD to focus on repair derived from our own cells.”

After seeing initial success in treating Crohn’s fistulas with adipose or bone marrow derived mesenchymal stem cells from healthy donors, Dr. Lightner is initiating a Phase 1 trial to explore a novel regenerative acellular therapy. The trial will be the first of its kind in perianal fistula, which affects approximately 25 percent of people with Crohn’s disease.

Translation into Practice Platforms
Dr. Lightner is the enterprise medical director for the Translation into Practice Platforms (TIPPs) for the Center for Regenerative Medicine. The platform accelerates regenerative medicine clinical trials and advancements into clinical practice. Teams provide help with protocol design and writing, and support in communicating with the U.S. Food and Drug Administration.

Unique Laboratory
Dr. Lightner’s research space is best described as a regenerative medicine surgical lab. This all-encompassing lab is working on optimizing regenerative products like extracellular vesicles and engineered mesenchymal stem cells.  The work in the lab can be applied to other disease states, allowing these products to cross disciplines. The goal is to bring multiple investigators together, and find novel regenerative therapies for the treatment of multiple diseases.

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