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Wed, Aug 21 6:00am · Regenerative Medicine Minnesota: Executing big hairy audacious goals

The excitement at the 2019 Regenerative Medicine Minnesota meeting was palpable. Health care providers, scientists, educators, students, lawmakers and life sciences entrepreneurs mobilized to celebrate the BHAG—big hairy audacious goals in transforming health care. The BHAG challenge: develop new solutions and innovations that establish Minnesota as a world class leader and destination for advancing regenerative medicine into daily practice. Mayo Clinic hosted this year’s Regenerative Medicine Minnesota meeting in Rochester.

Regenerative Medicine Minnesota is a statewide bipartisan initiative aimed at revolutionizing health care from a focus on treating disease to one of tapping the body’s ability to heal itself. Regenerative Medicine Minnesota seeks to build on the synergies of education, technology and research to create this new landscape in health care.

Saranya Wyles, M.D., Ph.D., is one of many innovators who seized the BHAG challenge. Her “Mission to 2025” proposal is one of the nine Regenerative Medicine education grant awards for 2019.

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

“Our goal is to provide regenerative medicine education to all medical students who train in Minnesota by 2025,” says Dr. Wyles. “We need to prepare the next-generation physician-scientists so they can safely advance the latest regenerative innovations into clinical practice. We also want them to have the fluency and resources to answer questions as patients learn about and seek regenerative care. ”

Dr. Wyles’ grant will build on the Mayo Clinic Center for Regenerative Medicine sponsorship and previous Regenerative Medicine Minnesota funding that provided resources to establish the first patient-centered regenerative medicine medical school curriculum. This course has trained more than 200 students to date.

“We highlight ongoing clinical trials, pre-clinical models, bench-to-bedside translation, procedural simulations, interactive patient experiences and basic science lectures,” says Dr. Wyles. “The Regenerative Medicine Minnesota grant enables us to attract and further retain medical trainees in this emerging field by providing travel awards and research scholarships for summer internships in regenerative sciences laboratories.”

The Regenerative Medicine Minnesota annual meeting is a time for all innovators to share their accomplishments and build strategic collaborations to accelerate them. Regenerative Medicine Minnesota BoardCo-Chairs Andre Terzic, M.D., Ph.D., director ofMayo Clinic Center for Regenerative Medicine andJakub Tolar, M.D., Ph.D., dean of the Medical School and vice president for Clinical Affairs at the University of Minnesota, outlined the initiative’s major achievements. In five years of this legislative initiative, Regenerative Medicine Minnesota has awarded 161 grants totaling $21.9 million of dedicated investment. Grants fund education, research and technology throughout the state.

This year’s $4.35 million in awards will fund:

Photo of Dr. Terzic
Andre Terzic, M.D., Ph.D.

  • Eleven research grants
  • Nine education grants, including six grants to train k-12 students in regenerative sciences
  • Eight biobusiness development awards

“Minnesota’s investment in regenerative medicine has led to tangible advancements in regenerative sciences, translation of new knowledge and the rollout of clinical trials to offer patients hope of new, validated regenerative solutions to improve their health,” says Dr. Terzic.

Picture of Dr. Tolar
Jakub Tolar, M.D., Ph.D.

“We are putting Minnesota at the forefront of introducing regenerative therapies into clinical practice,” adds Dr. Tolar. “Regenerative Medicine Minnesota has taken a novel approach to reaching these goals, developing a pipeline that integrates everything from developing new therapies, to recruiting and retaining the highly trained workforce of the future needed to administer these therapies, to building the industry’s capacity to produce them.”

Examples of the research supported by Regenerative Medicine Minnesota grants at the University of Minnesota and at Mayo Clinic include:

  • Performing fetal surgery to correct underdeveloped lungs before the baby is born.
  • Growing replacement blood vessels for coronary artery bypass.
  • Building an artificial liver to function until a human donor is located.
  • Developing a 4D printed system to guide delivery of stem cells: where, how, as what and when to deploy.

Three legislators who’ve been strong advocates, namely — Rep. Tony Albright, R- Prior Lake, Sen. Richard Cohen D- St. Paul, and Senator David Senjem R-Rochester — appeared on a legislative panel at the meeting where they affirmed their support and direction of Regenerative Medicine Minnesota. With that support, the BHAG — big hairy audacious goals — may one day become reality in daily patient care.

Dr. Terzic is the Michael S. and Mary Sue Shannon Director, Mayo Clinic Center for Regenerative Medicine, and Marriott Family Professor in Cardiovascular Diseases Research.

Dr. Tolar is the Dean of the University of Minnesota Medical School and a Distinguished McKnight Professor in the Department of Pediatrics, Blood and Marrow Transplantation.

Grantees are recognized at the Regenerative Medicine Minnesota annual meeting

Watch a video overview of the 2019 Regenerative Medicine Minnesota grants:

This story originally appeared on Mayo Clinic’s Center for Regenerative Medicine blog.

Thu, Aug 15 6:00am · HLHS consortium gives hope to babies with rare congenital heart defect

Hypoplastic Left Heart Syndrome (HLHS) is a rare disease that affects approximately 1 of every 4,300 babies every year.  HLHS is a congenital heart defect in which the left side of the heart is underdeveloped. It occurs during fetal growth when the baby’s heart is developing. Without immediate intervention after birth, 95% of infants with HLHS will die within a few weeks.[i]

TheTodd and Karen Wanek Family Program for HLHS at Mayo Clinic is the catalyst that brings together hospitals to address this serious health condition. Together they’ve formed a national consortium to give patients more options when it comes to participating in innovative clinical trials and other HLHS research.  This consortium, consisting of eight members, aligns regional centers and an advocacy group into a collaboration to accelerate innovation and discovery sciences, as well as bring clinical trials and expertise to patients across the country. The Ochsner Hospital for Children in New Orleans, Louisiana, is the latest to join the HLHS Consortium.  

All consortium members are participating in a phase II clinical trial using stem cells from a baby’s own umbilical cord blood in regenerative therapy. During the second of three surgeries to repair the heart, stem cells are injected into the heart muscle to help it grow stronger, with the goal to delay or prevent the need for transplant. The trial is open at all consortium sites, and Ochsner Hospital for Children already has collected cord blood with stem cells waiting to be used for a patient when the trial opens there later this year.

This story originally appeared on Mayo Clinic’s Center for Regenerative Medicine blog.

Tue, Aug 6 6:00am · Researching stem cell therapy for hemorrhagic stroke


Stroke
 is the leading cause of permanent disability in the U.S., striking nearly 800,000 people each year, according to the Centers for Disease Control and Prevention. In the last decade, there has been preclinical research that led to a small number of early phase clinical trials using mesenchymal stem cells (MSCs) as a possible treatment to reverse damage from hemorrhagic stroke. That’s the type of stroke in which a blood vessel breaks, causing bleeding on the brain. Within minutes, brain tissue starts to die which may cause paralysis, loss of speech or other disabilities. In a recent paper, Mayo Clinic researchers review the current studies using MSC therapy for hemorrhagic stroke in an effort to summarize the status of research and discuss the advantages and limitations of the various studies. The goal is to determine whether continued research around stem cell therapy for stroke patients would be warranted.

Medical illustration of ischemic and hemorrhagic stroke.

MSCs are an example of adult stem cells. They can be isolated from several tissues and differentiated into other cell types including, possibly, neurons. Researchers are trying to discover whether use of MSCs is beneficial in promoting repair of injured brain tissue.

“After more than 10 years of preclinical research looking at MSC therapy for hemorrhagic stroke in animal models, this review is a step towards translation from preclinical data to human trials in an effort to build consensus around the safety and tolerability of MSCs to guide future research, says Toni Turnbull, Ph.D., Mayo Clinic research fellow and lead author of the paper.

The researchers found that clinical trials using MSC therapy for hemorrhagic stroke are currently limited; however, initial positive preclinical and clinical results strongly suggest that further investigation into MSC therapy for hemorrhagic stroke is timely.

“Through our review, we found that preliminary evidence indicates that MSCs are both safe and tolerable in patients, says Mayo Clinic neurologist and critical care expert William Freeman, M.D. “However future randomized controlled trials are required to translate the promising preclinical research into an effective and validated therapy for hopeful patients.”

Researchers emphasize that timing, dosage and route of administration are all variables that need to be considered, controlled for and tested.

“Given the devastating effects of hemorrhagic stroke, and the millions of patients it affects, there is an understandable drive to develop this therapy for human use,” says Dr. Turnbull. “Additional studies will be needed to determine whether stem cells hold promise as a treatment option for stroke and other neurological disorders.”

This story originally appeared on Mayo Clinic’s Center for Regenerative Medicine blog.

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.

###

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.

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