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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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.

Oct 16, 2018 · Regenerative medicine facilities and expertise in Florida

The Regenerative Medicine Therapeutic Suites has seen 1,000 patients since opening on Mayo Clinic’s Florida campus almost two years ago. The model, which integrated patient care with laboratory functions, is enabling the development and use of regenerative medicine products.

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.

The Regenerative Medicine Therapeutic Suites have prompted — and been used in — several research projects in the areas of orthopedics, dermatology, reconstructive surgery and gastroenterology. From the treatment of pressure wounds to stroke to Alzheimer’s disease and beyond, the suites ensure a seamless pathway to translate emerging regenerative treatments to patient care.

In the video below, Shane Shapiro, M.D., program director for the Regenerative Medicine Therapeutic Suites and assistant professor of orthopedic surgery discusses the results of his randomized controlled trial of bone marrow aspiration and concentration for knee osteoarthritis.

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

Oct 9, 2018 · Diabetes 3, 2, 1

Often people with diabetes have brain changes that are hallmarks of both Alzheimer’s disease and vascular dementia. Some researchers believe that each condition fuels the damage caused by the other. That link may occur as a result of the ways that type 2 diabetes affects the ability of the brain and other body tissues to use sugar (glucose) and respond to insulin.

“To function well, the neurons in your brain need fuel. If you don’t have a good blood supply to the brain, then you don’t get enough glucose,” says Guojun Bu, Ph.D., Mayo Clinic neuroscientist and associate director of the Center for Regenerative Medicine at Mayo Clinic in Jacksonville, Florida.

The reduction of blood flow to the brain caused by damaged blood vessels may be why those with diabetes have a higher risk of Alzheimer’s disease. Diabetes and Alzheimer’s disease are connected in ways that aren’t yet fully understood. Dr. Bu and other researchers are studying how insulin resistance may affect the brain and result in Alzheimer’s disease or other types of dementia.

The connection between diabetes and Alzheimer’s was recently discussed in the Everyday Health article, Why Some Researchers Are Calling Alzheimer’s Disease a ‘Type 3 Diabetes’. “It’s really more of a research term, rather than a medical term,” explains Dr. Bu. About 20 percent of the human population carries the riskier form of the gene APOE, called the E4. It is anticipated that more than 50 percent of Alzheimer’s cases can be linked to APOE4, according to the study, which was published in Neuron.

Learn more about Dr. Bu’s research in the video below:

Regenerative Endocrinology Research at Mayo Clinic

The endocrine cells of the pancreas are responsible for maintaining blood glucose levels. Glucose-responsive, insulin-secreting cells in the islets (beta cells) are dysfunctional in both type 1 and type 2 diabetes. In type 1 diabetes, beta cells are destroyed, while in type 2 diabetes, they may not produce enough insulin.

The Islet Regeneration Program at Mayo Clinic is poised to develop novel therapies for diabetes. The islet regeneration researchers are taking multiple approaches to restore, protect and replace pancreatic islets.

Mayo Clinic researchers are also investigating gene therapy as a potential means of enhancing the body’s natural ability to regenerate beta cells.

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

More Information

Neurobiology of Alzheimer’s Disease
Islet Regeneration
Stem Cell Differentiation for Diabetes

Sep 18, 2018 · Advancing regenerative medicine practice, science and technology - 2018 symposium

Recent practice advancements, scientific discoveries, product development and manufacturing are the topics featured at the 2018 Mayo Clinic Symposium on Regenerative Medicine and Surgery. Regenerative medicine leaders from around the globe will come together Nov. 29 – Dec. 1 at the Westin Kierland Resort in Scottsdale, AZ. This year’s symposium will emphasize clinical trial breakthroughs and 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 will also be presented.

“The symposium is a forum for the regenerative medicine community to engage and learn how science driven practice advancements in regenerative medicine are increasingly embedded in daily practice,” says Andre Terzic, M.D., Ph.D., the Michael S. and Mary Sue Shannon Family Director, Center for Regenerative Medicine, and the Marriott Family Director, Comprehensive Cardiac Regenerative Medicine. “We’re looking forward to hosting the growing regenerative medicine community to share experiences in bringing regenerative medicine breakthroughs to clinical trials and practice applications addressing patient needs.”

Keynote speakers, Richard McFarland, M.D., Ph.D., chief regulatory officer at Biofab (left), and Peter Marinkovich, M.D., associate professor of Dermatology at Stanford University (right).

Hear from keynote speakers on trends in clinical application, discovery science, regulatory science, cGMP manufacturing and quality assurance, and clinical trials. Sessions planned for the three-day symposium include:

  • Regenerative Medicine Breakthroughs
  • Intervention Spotlight
  • Clinical Trials & Clinical Experience
  • Regenerative Discoveries
  • Future of Regenerative Medicine
  • Accelerating Therapies to Application
  • Enterprise Translational Capabilities
  • Interactive Training and Education sessions

Keynote Speakers

Richard McFarland, M.D., Ph.D., chief regulatory officer at Biofab, will share best practices in industry partnerships to accelerate regenerative therapies into patient care. Peter Marinkovich, M.D., associate professor of Dermatology at Stanford University, will present the progress of skin regeneration in patients with Epidermolysis Bullosa, a genetic skin disease.

“Drs. McFarland and Marinkovich are renowned in the field of regenerative medicine, and we’re excited to have them present at the symposium,” says Richard Hayden, M.D., an otolaryngologist and director of education for the Center for Regenerative Medicine. “Additionally, the CAR-T cell therapy update and interactive education sessions will be highlights of the symposium.”

The symposium is open to everyone, including clinicians, researchers, educators, students, industry and the general public. Early registration discounts are available through Oct. 15 and student discounts apply.

Learn more about the 2018 Mayo Clinic Symposium on Regenerative Medicine and Surgery on the Center for Regenerative Medicine blog.

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