Posts (145)

3 days ago · Mayo Clinic Researchers Develop More Efficient System to Reprogram Stem Cells

Induced pluripotent stem cells, the workhorse of many regenerative medicine projects, start out as differentiated cells that are reprogrammed to pluripotent stem cells by exposure to a complex set of genetic cocktails. Mayo researchers now report that using the measles virus vector; they’ve trimmed that multi-vector process with four reprogramming factors down to a single “one cycle” vector process. They say the process is safe, stable, faster and usable for clinical translation. The findings appear in the journal Gene Therapy.

“If we’re going to successfully use reprogrammed stem cells to treat patients in the clinic, we need to ensure that they are safe and effective, that is, not prone to the risk of mutation and potential tumors,” says Patricia Devaux, Ph.D., Mayo Clinic molecular scientist and senior author of the article. “The measles virus vector has long been used safely at Mayo for treating cancer, so it is very safe. Now that we’ve combined a multiple-vectors process into one, it’s efficient as well.”

Previously, the four reprogramming factors – proteins OCT4, SOX2, KLF4 and cMYC – had to be introduced individually to the cells to induce them to change in the proper fashion for the desired outcome. That led to potential partially reprogrammed cells, as not all cells received the four factors required for reprogramming. The new Mayo process combines those factors within the measles virus vector so the process happens in one step and all targeted cells have the potential to reprogram. It should be noted that this measles virus is attenuated, that is all dangerous aspects of the virus have been removed, as they are in a vaccine, and the virus becomes a vector or carrier for other genetic material. The measles virus vaccine strain is often used today because it is safe, fast and targetable.

The researchers say a clinically applicable reprogramming system free from genomic modifications will go a long way to making widespread use of induced pluripotent stem cell therapies feasible. These are therapies in which an individual’s own cells are reprogrammed can then be use to work in a particular diseased organ, thus avoiding risk of cell rejection.

Additional co-authors of the article include first author Qi Wang, Alanna Vossen, and Yasuhiro Ikeda, D.V.M., Ph.D., all of Mayo Clinic. The research was supported by the National Institutes of Health, including the National Institute of Allergy and Infectious Diseases, National Center for Advancing Translational Sciences, Mayo Clinic Graduate School of Biomedical Sciences, and Mayo Clinic Center for Regenerative Medicine.

This article was first published on Mayo Clinic’s News Network.

Thu, Feb 7 2:52pm · 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 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

Thu, Jan 31 10:08am · Apply for 2019 Regenerative Medicine Minnesota grants

Regenerative Medicine Minnesota is accepting proposals for grants relating to regenerative medicine education programs, clinical care, and biobusiness/biotechnology. Applicants must be based in Minnesota.

Important notes for Mayo Clinic investigators:

Application process and deadlines
Request for proposal (RFP) details:

The Office of Sponsored Projects Administration internal deadline for submitting budget requests is Feb. 15, 2019. Applications are due to Regenerative Medicine Minnesota by Feb. 25, 2019.

Since the Minnesota Legislature allocated resources to fund the program, Regenerative Medicine Minnesota has been working to improve the health of Minnesotans by advancing regenerative medicine therapies. Grants have been awarded to accelerate medical research; to develop biotechnology and biobusiness; and to recruit, train and retain the next generation of health care workers and researchers in the field of regenerative medicine.

More information
Visit the Regenerative Medicine Minnesota website or contact Beth Borg, operations administrator, Center for Regenerative Medicine Administration, at (77) 4-1075.

Tue, Jan 29 10:16am · Seven 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 17 9:21am · Gerstner Family Donates $10 Million to Mayo Clinic

Mayo Clinic announced last fall that it received a $10 million grant from The Louis V. Gerstner Jr. Fund at Vanguard Charitable on the recommendation of Louis V. and Robin L. Gerstner.

The grant supports five initiatives across Mayo Clinic’s Arizona, Florida and Minnesota sites. Two of the five initiatives funded through the grant are designated to advance patient care through enterprise-wide regenerative medicine research and clinical trials at Mayo Clinic.

The Gerstner Spine Pain Initiative will support research and clinical trials for the most common cause of lower back pain, arthritis of the lumbar facet joints. The initiative includes the development of a spine pain registry for data collection and analysis of established pain interventions in comparison with regenerative cellular therapy. This effort is led by Wenchun Qu, M.D., M.S., Ph.D., a physiatrist and pain specialist and William Mauck, M.D., chair of the Division of Pain Medicine.

Shane Shapiro, M.D., assistant professor of orthopedic surgery and medical director of the Regenerative Medicine Therapeutic Suites in Florida will head the Gerstner Regenerative Medicine Initiative, supporting ongoing osteoarthritis research and clinical trials at Mayo Clinic. The Regenerative Medicine Therapeutics Suites will lead the study to develop evidence-based best practices for dosing and frequency of regenerative therapies for knee osteoarthritis. The initiative will also support the development of an outcomes registry.

The other three initiatives support specialized education opportunities for nurse practitioners and physician assistants, career development awards in the Center for Individualized Medicine, and research in the use of augmented human intelligence in cardiovascular care.

The needs of patients drive research at Mayo Clinic. As doctors treat patients and see opportunities for advancing patient care, they work together with Mayo scientists and research teams to develop new and improved diagnostic tools, medications, devices, treatment protocols and more.

With fewer traditional funding sources available for medical research, philanthropy has become a critical link that makes it possible for research programs to move beyond initiation.

This grant not only makes research and new education opportunities for the five initiatives above possible, it expedites the discovery, development and delivery of treatments and technologies that ultimately benefit patients.

Thu, Jan 10 2:03pm · Top Stories of 2018

With 2018 behind us, here’s a look at some of our most-read stories of the year. Be sure to stay up-to-date in 2019 by subscribing to the Mayo Clinic Center for Regenerative Medicine blog. You may choose to have updates sent as soon as they’re published or have a weekly email digest sent once per week.

 

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.

 

 

 

Cell Therapy for Cartilage Defects
Aaron Krych, M.D., a Mayo Clinic orthopedic surgeon, is researching the initial safety and feasibility of a single stage cartilage repair technique using the patient’s own cartilage cells and allogeneic mesenchymal stem cells.

 

 

 

 

Regenerative Medicine is the Future for Mayo Surgeon
While an innovative physician who is an expert at reconstructive pouch surgery, Dr. Lightner wants to see fewer inflammatory bowel disease surgeries. She is currently researching innovative cellular, non-surgical therapies.

 

 

 

 

Researching Cartilage Regeneration for Osteoarthritis
Mayo Clinic investigator, Jennifer Westendorf, Ph.D., is studying how proteins, called Girk2 and Girk3, contribute to cartilage formation and repair in the setting of osteoarthritis. Researchers believe that osteoarthritis may be prevented if these proteins are absent or inactive.

 

 

 

Golden Era in Medicine: Regenerative Medicine Symposium Looks to the Future
Over 200 providers, scientists, educators, students, entrepreneurs and patient advocates attended the 2018 Mayo Clinic Symposium on Regenerative Medicine and Surgery, where practice advancements, scientific discoveries, product development and access to care were just a few of the topics featured.

 

 

 

 

 

Thu, Jan 3 12:42pm · The Sky's the Limit

In 2011, Jared Ausnehmer left his local hospital carrying the weight of an oxygen tank and the worry of what might come next. At age 21, he’d already defied the odds for those born with hypoplastic left heart syndrome, a birth defect in which the left side of the heart is underdeveloped or nonexistent. With a new diagnosis of heart failure, his doctors revealed grim news: No conventional treatments existed. Then his parents, David and Patty Ausnehmer, saw a news broadcast that changed everything.

After further research online, they discovered the Mayo Clinic  Center for Regenerative Medicine and had a phone consult with Timothy Nelson, M.D., Ph.D., a physician and researcher whose work focuses on congenital heart disease. Dr. Nelson, the director of the Mayo Clinic Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome, told Jared’s parents that Mayo Clinic was starting stem cell therapy for infants with hypoplastic left heart syndrome and he hoped to one day have a trial for young adults like their son.

A Glimpse of Hope

Jared at home with his parents, Patty and Dave.

In the meantime, Jared’s new care team, made up of experts with the Mayo Clinic Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome and the Mayo Clinic Division of Pediatric Cardiology, suggested a more intense medication program to help him better tolerate the effects of a leaky valve. His heart showed that it had more “in reserve” than anyone expected.

“You have this feeling of, ‘My gosh, I’m finally in the right place,’” Patty says. “I saw people who care and were moving mountains for my child.”

Pediatric cardiologist Patrick O’Leary, M.D., said Jared’s heart needed to pump blood to his body rather than his lungs and more blood per minute due the leaky valve.

“The goal was to help Jared’s heart muscle cope with the extra workload it was facing,” says Dr. O’Leary. “Jared improved almost immediately and surprisingly continued to improve with each medication adjustment.”

With the improvement, Jared was able to continue his care from home in Ohio while waiting for a long-term solution to emerge. His care team knew his heart would eventually fail, but they did not know when. Flash forward to 2015 — the family received a long-awaited phone call from Mayo Clinic. Dr. O’Leary said they were ready to begin the stem cell clinical trial and wanted Jared to be the first of 10 participants.

A New Horizon

In the first clinical trial of its kind, Jared had 94 million stem cells from his own bone marrow injected into his right ventricle through a heart catheterization. The results were significant. His care team immediately noted an increase in heart function as the stem cells began to prompt weak areas of the heart to regenerate. Notably, the stem cell therapy was surpassing all expectations for Jared’s heart health. By August 2016, his heart strength had increased enough for him to undergo open-heart surgery where doctors inserted a pacemaker and replaced his leaky valve. After eight days in the hospital, Jared returned home to get back to a normal life. Two months after his surgery, he was cleared to play basketball.

“This pioneering work at Mayo Clinic empowers us all to envision a new horizon in health care,” says Andre Terzic, M.D., Ph.D., Michael S. and Mary Sue Shannon Family Director, Center for Regenerative Medicine; the Marriott Family Director, Comprehensive Cardiac Regenerative Medicine; and the Marriott Family Professor of Cardiovascular Medicine. “Through state-of-the-art research and continuous study, dedicated experts in the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome have rigorously advanced innovative regenerative therapies with the potential to transform the care of our patients.”

The trailblazing team of physicians, scientists and many other experts in the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome use a multifaceted approach that includes research into imaging and outcomes, human genetics and regenerative strategies. By using stem cells and other innovative regenerative technologies, Mayo Clinic is on the forefront of turning devastating diagnoses into potentially curable conditions for patients like Jared.

“Today, the sky’s the limit,” Jared says. “I just had a basketball game yesterday, and it feels like nothing is holding me back. I don’t have to worry — I just get to play.”

This article originally appeared in Mayo Clinic Magazine, Volume 32, Issue 1. 

Information about many of the clinical trials offered at Mayo Clinic can be found online.

Dec 20, 2018 · 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.

 

 

 

 

 

 

 

 

 

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