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Thu, Jul 16 8:20am · Regenerative patient consult service seeks to educate patients

Article by Charlene Martin-Lillie and Susan Buckles

Advances in Regenerative Medicine hold promise for many patients as the therapeutic paradigm shifts from treating disease to restoring health. As this evolving field of medicine matures, information becomes increasingly available to the general public through multiple venues, mostly online. Terms such as “stem cells”, “exosomes”, and “regenerative therapy” are prolific on internet searches and could easily be misunderstood. In fact, a Google search of the term “stem cells” alone returns more than 300 million results. How are people who are looking for answers as it pertains to regenerative medicine expected to sift through this information and find trusted data?

Research led by Zubin Master, Ph.D., a bioethicist for the Mayo Clinic Center for Regenerative Medicine, is the first to describe people who seek information on regenerative solutions. The study analyzed data collected by the Mayo Clinic Regenerative Medicine Consult Service, which included information about what types of questions were being asked and the demographics of callers.

The study, “Challenging misinformation and engaging patients: characterizing a regenerative medicine consult service,” published in Regenerative Medicine, finds that a patient consult service is a credible and helpful resource for patients who are seeking information about regenerative therapies, and more generally about the field of regenerative medicine.

Zubin Master, Ph.D.

With patients increasingly seeking health information online, the internet is playing an important role in distributing and amplifying scientific and therapeutic information, but some of the claims lack evidence and can mislead patients when considering a regenerative option,” says Dr. Master. “A patient consult service can help inform patients about the science behind regenerative medicine and whether regenerative therapies might provide the right complement to standard of care.”

Mayo Clinic launched the Regenerative Medicine Consult Service to help health consumers find trusted, scientifically-based information about validated regenerative procedures. The goal is to assist patients in finding appropriate regenerative options, as well as educating patients on the current state of the science as it pertains to regenerative therapies and available clinical trials.

Furthermore, Mayo Clinic in Florida developed a consult service that is integrated with the Regenerative Medicine Therapeutic Suites, with a specific emphasis on musculoskeletal conditions. Shane Shapiro, M.D., medical director of the Regenerative Medicine Therapeutic Suites and Jennifer Arthurs ARNP, coauthors on the paper, consult with patients across a broad spectrum of inquiries and often find that patients are not well aware of the fact that there are many regenerative medicine procedures that do not involve stem cells.

Shane Shapiro, M.D.

“Stem cells have become a buzz word. Sometimes the treatments patients hear or ask about do not contain any actual stem cells but may still be regenerative in nature by using other kinds of cells, cell products and growth factors that help with the healing process,” says Dr. Shapiro.

To date, Mayo’s consult services have provided educational information for over 5,600 patients from the United States and other countries.

The research

Dr. Master’s team analyzed a total of 503 clinical consult notes from Mayo Clinic in Minnesota, as well as demographic information from 1,319 patients from both Minnesota and Florida. Patients looking for regenerative options are health consumers who have typically done a great deal of research on their own to find treatments for their particular medical condition. Many have tried one or more conventional treatments, but did not find relief. Typically, these patients and their families are highly motivated to seek something that can help them.

This group of information seekers was generally over 60 years old and evenly split between male and female.  A majority of callers were seeking information about regenerative orthopedic care followed by pulmonary, cardiology and neurology care. The researchers also conducted interviews with 25 patients to find out that most express their appreciation for the consult service, which they found to be informative and helpful. Patients also reported that the Mayo staff members they spoke with were knowledgeable and professional.

Through the Regenerative Medicine Patient Consult Service, Mayo Clinic is able to provide information which patients and health care providers together could determine the best care plan. Both Dr. Shapiro and Dr. Master credit Jennifer Arthurs, advanced practice registered nurse, and Charlene Martin-Lillie, patient educator, for the success of the patient consults. They are often the first points of contact who listen, educate and explain the regenerative and standard of care options.

“Developing trustworthy and evidence-based resources to engage patients seeking regenerative interventions is critical and part of the responsible translation of regenerative medicine. This way we can help patients make informed decisions about their healthcare, especially in the context of medical misinformation.” says Dr. Master.

By analyzing the nature of the consultations, regenerative medicine providers may better understand patient needs and can continue to enhance the consult service to meet those needs.

To learn more about with the Regenerative Medicine Consult Service at Mayo Clinic please call 844-276-2003 to schedule a telephone appointment or (904) 953-0857 to schedule a consult with the Regenerative Medicine Therapeutic Suites in Florida.

###

Other authors on this paper:

Cambray Smith, Mayo Clinic Biomedical Ethics Research Program
Charlene Martin-Lillie,  Mayo Clinic Center for Regenerative Medicine
Jennifer Dens Higano, Mayo Clinic Alix School of Medicine
Leigh Turner, Ph.D., Center for Bioethics, University of Minnesota
Sydney Phu, Oregon State University
Jennifer Arthurs, Mayo Clinic Regenerative Medicine Therapeutics Suites
Timothy Nelson, M.D., Ph.D., Mayo Clinic

Nov 8, 2019 · 'Feel the Beat' is About Hope, Healing and Camaraderie, and it's Easy to Dance to

Families, researchers and clinicians recently came together to
raise awareness and celebrate how regenerative research enhances the lives of
individuals with Hypoplastic
Left Heart Syndrome
(HLHS), a rare
congenital heart disease.

HLHS is a rare and complex form of congenital heart disease in
which the left side of a child’s heart is severely underdeveloped. Regenerative
medicine strategies for HLHS is one of several approaches the Center
for Regenerative Medicine
 is studying that
goes beyond disease management to search for and discover therapies that
support the body in repairing, regenerating and restoring itself to a state of
well-being.

Kids with HLHS, “often don’t meet other people like
themselves,” according to Brianna Tranby, senior research program coordinator
in the Todd
and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome
. That’s one reason the annual — and cleverly named — “Feel
the Beat” event is something of a homecoming for HLHS patients and their
families, the HLHS research coordinator tells us. “We had 142 attendees
this year,” she says. “Many had attended the event previously, but
some were first-timers who had never met someone else with HLHS.”

Naomi Babcock

The event was created in 2013 as a way to “bring HLHS families together and thank research participants for their contributions” to ongoing HLHS research, Tranby says. This year, one of those research participants took center stage, literally and figuratively. Naomi Babcock’s story shows how much someone living with HLHS is capable of achieving despite the physical and emotional tolls of the rare condition.

“Naomi is an
18-year-old high school senior with HLHS who’s in full-time training to be a
professional ballerina,” Tranby tells us. During a panel discussion at the
event, Naomi and her mom, Kelly, talked about Naomi’s experiences “growing
up with HLHS, the physical demands ballet has had on her body, and what it’s
been like for her to leave home and take care of herself while also managing
her condition.”

Then Naomi showed her
fellow patients just what was possible, performing a ballet routine for those
attending the event. “I think it was important for other people with HLHS to
see that so they know HLHS is something you can actually live with,” Tranby
says. “You can live to adulthood and still do physical activities. That’s
something that’s really important to our HLHS program at Mayo Clinic and is
what inspires the groundbreaking research we’re doing.”

That research is something Tranby tells us Mayo Clinic cannot do
on its own. “The Todd and Karen Wanek
Family Program for HLHS
 was started at Mayo
Clinic in 2010,” she says. “Because the condition is so rare, no
single hospital sees many HLHS patients, which makes research challenging.”
So in 2017, Mayo Clinic created a nationwide HLHS Consortium to align centers of excellence and collaborate in clinical
trial research. The consortium, now
up to eight members
, includes both hospitals
and patient/family advocacy groups with the shared goal of improving the lives
of people with HLHS through research.

People like Naomi Babcock and 140-some friends who attended this
year’s “Feel the Beat” event.

###

This story first appeared on Mayo Clinic’s In
the Loop
blog
.

Sep 20, 2019 · Biomanufacturing in Discovery Square Building will Bring New Options to Patients

The grand opening of One Discovery Square opens a new
chapter in biomanufacturing focused on connecting patients with complex medical
conditions with novel biotherapeutic solutions.

The Mayo Clinic Center for Regenerative Medicine Advanced
Biomanufacturing facility is one of the Mayo tenants in the building focused on
the acceleration of new health care products to market by partnering innovation
with industry.

When it is fully up and running in One Discovery Square, the
facility will seek to develop first-of-their kind therapeutic products, and
together with industry collaborators, move them quickly from the bench to the
bedside for Mayo patients and then others around the world.   

A new era of regeneration, biomanufacturing harnesses
biomaterials and biomolecules for use in medicine. The resulting new generation
of health care products has the potential to bring new treatment options to
patients.

“In biomanufacturing, technologies have historically come
with significant cost of manufacturing,” says Atta
Behfar, M.D., Ph.D.
, a cardiologist and deputy director of translation for
the Center for Regenerative Medicine. “Forged with the vision of industry
collaboration, the goal for Discovery Square is to establish transformative
biomanufacturing platforms that will ultimately connect patients with
untreatable conditions with accessible curative technologies.”

The Center for Regenerative Medicine Advanced
Biomanufacturing facility is led by Dr. Behfar and Andre
Terzic, M.D., Ph.D.
, the Michael S. and Mary Sue Shannon Director, Mayo
Clinic Center for Regenerative Medicine.

“The effort in One Discovery Square will allow us to forge
an ecosystem of innovation by partnering with industry to establish next
generation regenerative technologies at Mayo Clinic. With a focus on scaled and
targeted biomanufacturing platforms, the acility is poised to establish new
regenerative tools adapted for rapid integration into practice,” says Dr.
Terzic.

Biomanufacturing in
Patient Care

There are many implications of biomanufacturing in health
care. The Mayo Clinic Center for Regenerative Medicine is leading several
efforts that will advance patient care, including:

  • Cellular and gene therapy: These two types of therapies offer therapeutic intervention for a range of diseases for which relatively limited clinical options are currently available. Cellular therapies contain cells or tissues derived either from a donor or a person’s own stem cells that employ healing through replacement of function. Gene therapy is the addition of new genes to a patient’s cell to replace missing or malfunctioning genes that are driving disease.
  • Acellular technology: Acellular — or cell free — technology are biologics that are termed “off-the-shelf.” It means they can be manufactured and stored for long periods of time right at the hospital, as opposed to needing to be frozen, thawed and brought to a patient.  Cell free products are less generally expensive for patients and can be used more widely.
  • Tissue engineering: The goal of tissue engineering is to assemble functional constructs that restore, maintain, or improve damaged tissues or whole organs using scaffolds, cells and biologically active molecules. Tissue engineering uses new approaches to repair, restore or regenerate tissue function lost due to injury, chronic disease and aging.

Biomanufacturing Challenges

One of the challenges in biomanufacturing is having the
proper technology and production capabilities in place to meet rigorous
standards for U.S. Food and Drug Administration (FDA) approval.  A key component of that is the highly
regulated Current Good Manufacturing Practices (cGMP) laboratory needed to
research and produce these new products, such as cellular and acellular
therapies, pharmaceuticals, medical devices, and engineered tissues. The Center
for Regenerative Medicine Advanced Biomanufacturing facility will feature cGMP
lab space, which is important to assure proper design, monitoring, and control
of manufacturing processes and follows cGMP regulations established and
enforced by the FDA.

“One Discovery Square provides a central location to
develop, translate and apply new biologics that are unique to Mayo Clinic,”
says Dr. Behfar.  “Our goal has always
been to get the latest technologies to patients quickly.”

Aug 22, 2019 · New Florida Building Dedicated to Medical Discovery and Innovation

Discovery and Innovation Building

The grand opening of the new Discovery and Innovation
Building at Mayo Clinic’s Florida campus signals a new era of integrating
regenerative medicine into daily practice. Regenerative medicine seeks to tap
the body’s ability to replace, restore or regrow damaged or diseased cells,
tissues and organs. A hub of research and technology, the new building could advance
new regenerative treatment options for lung disorders, transplants, arthritis,
and many other conditions.

“It will bring us closer to our goal of making Mayo Clinic
in Florida the regenerative medicine destination center of the Southeast,” says
Abba Zubair, M.D., Ph.D., who specializes in
transfusion medicine and regenerative medicine on Mayo Clinic’s Florida campus.
“The Discovery and Innovation Building provides space that will significantly
expand our capacity to support clinical trials in Florida.”

Ex vivo perfusion and ventilation of a donor lung

On
the first floor of the Discovery and Innovation Building, Mayo Clinic and United
Therapeutics Corporation
 are collaborating to combine expertise on
United Therapeutics’ new lung technology known as lung perfusion technology. Lung perfusion is a pioneering technology that may increase
the number of lungs available for transplant. It is a process by which
marginal donor lungs are restored through flushing and ventilation while monitored
in isolation. This preserves lungs for transplantation that otherwise would
have been discarded. The lungs will be made available to
patients at Mayo Clinic and other transplant centers throughout the United
States.

In addition to lung restoration, researchers will use stem
cells from healthy volunteer donors in the setting of FDA approved clinical
trials to treat lung rejection (transplant related bronchiolitis obliterans),
stroke, chronic obstructive pulmonary disease, interstitial lung disease,
vascular fistulas and many more trials in the pipeline.

“We’re at a pivotal
point in the field of regenerative medicine,” says Dr. Zubair. “We’re now able
to expand our knowledge across specialties and are starting to look at scaling
up production in order to effectively reach more patients.”

Researchers in a cGMP clean room.

The building will also feature a Current Good Manufacturing
Practices (cGMP) laboratory, which is important to assure proper design,
monitoring, and control of manufacturing processes. A cGMP facility follows current
good manufacturing practice regulations established and enforced by the Food
and Drug Administration (FDA), ensuring the quality of drugs, medical devices
and blood.

Here,
in coordination with enterprise-wide biomanufacturing activities, a Mayo Clinic
cGMP laboratory will focus on manufacturing allogenic (donor-derived),
engineered, and automated regenerative medicine products. The testing and optimizing of automation in biomanufacturing
will lead to scale up of regenerative products in order to produce better, safe
and cost-effect products, such as engineered allogenic mesenchymal (adult) stem
cells.

Studies have already been done to advance
the cell therapy space through identification of suitable donors, ideal tissue
sources, the optimized bioreactor conditions and novel methodology for cell
administration.

The new cGMP facility is expected to be fully operational by
the end of 2020; however, clinical trials are already underway in another area
of the campus and being used to develop new technologies which will continue to
be researched and scaled up in the new facility.

“Once the facility is up and running in the new building,
we’ll be able to immediately expand the current clinical trials,” says Dr.
Zubair. “Then it’s time to take
these technologies and develop them in a way in which we can get them to
patients safely and quickly.”

The
Life Sciences Incubator, within the Discovery and Innovation
Building will commercialize discoveries from within the Mayo Clinic
research labs and seeks to bring them to market quickly.  It will also host life sciences companies from
across the United States and around the world that could benefit from being
co-located with Mayo Clinic resources on the Mayo campus.

“Expansion
of our automation and cytoengineering capabilities in the Discovery and
Innovation Building further positions Mayo Clinic as a trusted center of
excellence in the regenerative medicine space,” says Atta Behfar, M.D.,
Ph.D.
, deputy director of
translation for the Center for Regenerative Medicine across Mayo Clinic. “This
transformative effort in Florida will allow development of novel therapies for
patients who connect with us for hope and healing.”

Each
Mayo Clinic campus has a unique set of regenerative medicine capabilities
researching innovative solutions for patients. Together they form the Center
for Regenerative Medicine, working as a whole to create new solutions to
transform medicine and surgery.

Jul 19, 2019 · Regenerative Medicine Minnesota: Executing Big Hairy Audacious Goals

Thank you for your interest. We would be happy to connect with you regarding regenerative medicine research, stem cell treatments and/or research at Mayo Clinic. Please call our Regenerative Medicine Consult Service at 844-276-2003 to schedule an appointment to speak with us. There is no charge for the appointment. We look forward to hearing from you.

Jun 21, 2019 · 6 "firsts" in advancing regenerative medicine toward patient care

Thank you for your interest. We would be happy to connect with you regarding regenerative medicine research, stem cell treatments and/or research at Mayo Clinic. Please call our Regenerative Medicine Consult Service at 844-276-2003 to schedule an appointment to speak with us. There is no charge for the appointment. We look forward to hearing from you.

May 17, 2019 · 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:

May 3, 2019 · 3D Models: Printing the Future of Medicine

Amy Alexander looking down on 3D printer

The soft glow of Amy Alexander’s alarm clock in the darkness
toyed with her attempt to fall back to sleep. Her thoughts wandered to the job
she left on the printer the night before. Knowing she wouldn’t rest until she
knew it was running smoothly, Amy headed into work early.

As part of the Anatomic Modeling Lab at Mayo Clinic, Amy, a biomedical engineer, pressed print the day before on a life-sized 3D model of a 35-year-old man’s face for a surgeon preparing to repair a misaligned jaw.

The model, which took about 12 hours to complete, ran through
the night to be ready in time. It held the key to the surgeon’s preparation to
restore the man’s ability to perform seemingly simple tasks such as eating
solid foods.

For this particular craniofacial surgery, the surgeon planned to
take three pieces of the patient’s leg bone and attach it to the jaw — a
procedure he had done many times before. But, because he had a model of the
patient’s exact facial anatomy, he was able to rehearse the surgery and knew in
advance precisely where to make the cuts and what to expect during the
operation, making the procedure quicker and less invasive. This surgical
simulation supports better outcomes and faster recovery times.

“Medicine is very visual, and 3D models represent another way to look inside a patient, look at the disease,” says Jonathan M. Morris, M.D., a neuroradiologist and co-director of Mayo Clinic’s 3D modeling lab. “Surgeons can hold, manipulate and see a specific patient’s anatomy with a clarity that cannot be replicated in two dimensions on a computer.”

Mayo Clinic’s journey into 3D anatomical modeling began in 2006 when planning for the complex and critical separation of conjoined twins who shared a liver. The success of the surgery and the usefulness of the anatomical models spurred additional requests for 3D printing. As a result, Mayo Clinic has become a leader in anatomical modeling and 3D printing.

“It’s an educational tool we can offer to provide next-level visualization to contribute to precision surgery,” says Jane Matsumoto, M.D., radiologist and co-director of Mayo Clinic’s 3D Anatomic Modeling Lab.

Mayo Clinic uses 3D models for planning and practicing procedures in all medical specialties. Many surgeons also use the models as educational tools for current and future physicians, and as a visual to explain diagnoses to patients and families and talk through treatment options.

Physician-scientists are also building off of this foundation
in regenerative medicine to recreate living
tissue in a process called bioprinting. This experimental technology uses a
scaffold seeded with cells to mimic tissues such as skin, bone, muscles and
valves so patients might someday have a nonmechanical replacement for their
damaged tissue. For example, cardiologist Amir Lerman, M.D., Barbara Woodward Lips
Professor, is researching bioprinting heart valves to free patients from the
need for multiple surgeries or the fear of blood clots.

From tumor resections to facial reconstructions and heart surgeries, 3D models take away guesswork and facilitate communication among physicians and scientists.

“It’s a tool we can use to offer individualized care,” Dr. Matsumoto says. “The demand for 3D printing at Mayo Clinic is really a reflection of the high level of surgery our surgeons do here.”

This article originally appeared in Mayo Clinic Magazine. Read the
full story in the Fall 2018 edition.

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