Posts (12)

Thu, Mar 19 8:00am · Regenerating diseased bones

Kendall Koens’ life is a dramatic reversal from what it was
in 2006. Late stage cancer left him in a coma and on a ventilator fighting for
survival. Aggressive chemotherapy was saving his life but slowly and silently
destroying his hips joints. The financial planner from Rochester faced
crippling pain typical of someone more than twice his age until a regenerative surgery
pioneered at Mayo Clinic restored life to his bones.

Cancer leads to bone
disorder

Mr. Koens was 26 years old when doctors discovered a grapefruit size cancerous tumor in his chest. Chemotherapy and heavy steroids fought the germ cell cancer but left him with lung damage and a rare side effect that surfaced four years later. He developed avascular necrosis  of the hip, a condition in which blood stops flowing to the top of the hip joint known as the femoral head. Avascular necrosis, also called osteonecrosis, causes bone cells to die. Tiny fractures that result sometimes lead to collapse of the joint.

Kendall Koens

“I was facing the possibility of needing a hip replacement. It
was pretty concerning from a long term point of view.” says Kendall Koens. “Hip
replacements only last so long. Being young, I knew that if I had a hip
replacement, I might need a second or maybe even a third hip surgery over the
course of my lifetime.”

Koens’ primary physician referred him to Rafael
Sierra, M.D.
, a Mayo Clinic orthopedic surgeon who specializes in treating
disorders of the hip and often with the newest regenerative treatments. 

Rafael Sierra, M.D.

“Avascular necrosis in the past has been described as one of
the unsolved mysteries of orthopedics, because we really don’t have a way,  once it has started , of halting the process
of the dying bone or even changing the natural history unless you catch it
early,” says Dr. Sierra. “Without treatment, up to 90 percent of all people
with this condition will need a hip replacement.”

Dr. Sierra recommended surgery that taps into the body’s own
healing powers to restore dead bone tissue. Mayo Clinic was one of the first
medical centers in the United States to offer this regenerative treatment. It’s
a hip decompression surgery in which a small hole is drilled in the outside of
the bone to access the femoral head to release pressure with the hopes of
improving the blood flow to the damaged bone. This procedure is further
fostered by a regenerative biotherapy.

“After the decompression, we take bone marrow from the
pelvis that has the stem cells. We spin it in a centrifuge that separates red
blood cells from the mononuclear cells that play a key role in healing.  These mononuclear cells are then injected back
into the hip where they act as healing agents,” says Dr. Sierra.  “It is done as an outpatient procedure that
takes about an hour. Generally there is very little pain and very low morbidity
for the majority of patients.”

This type of modern hip decompression, with injection of
bone marrow concentrate  and bone graft
done within the constraints of the operating room, is an approved therapy. The
goal is to avoid or delay hip replacement for patients like Kendall Koens whose
osteonecrosis is still in an early, treatable stage.  Recovery time varies based on how far the bone
decay has advanced prior to treatment. If caught early, recovery may be quicker
than a hip replacement, but in later stages if surgery is performed to save the
femoral head, recovery could take more time. 

Although this was a new procedure, Koens decided it was
worth the risk to avoid a hip replacement. In 2010, he became one of the first
patients at Mayo Clinic to have the hip decompression surgery.

“After meeting with Dr. Sierra and hearing about this
surgery, we were so excited and full of hope. At the time it felt like an
unbelievable opportunity. I decided to have it done and take it a day at a
time.  Here it is a decade later, and I’m
doing well,” he says.

Koens’ life continues to take positive turns. His
cancer is in remission. He lives an active lifestyle.  Though cancer left him unable to have his own
children, he and his wife became parents two years ago to two adopted
daughters. He regularly takes walks with his family and has no problem chasing
after two energetic preschoolers.

The Koens family

“I live a very normal life and don’t have any pain. I’m so
grateful that I haven’t had to go through a life of hip replacements. I can’t
imagine what that would mean for activity restrictions. My life would be so
much different,” Koens says.  “Dr. Sierra
told me to avoid running marathons and playing sports like basketball that have
a heavy impact on the hips. I’m not a marathon runner anyway, so this
recommendation didn’t change the course of my life.”

Helping
hundreds avoid hip replacement

Dr. Sierra has performed as many as 300 hip decompression surgeries.
Many of the patients are younger people like Kendall Koens who wanted an
alternative to a total hip replacement.  

“Hip replacements are common and we love doing them.  However, if we can avoid them, it is in the
patient’s best interest long term.

Dr. Sierra’s practice is based on scientific evidence. He
regularly conducts research to improve surgery to treat avascular hip necrosis,
an example of science-driven practice advancement at Mayo Clinic.

Mayo
Clinic Center for Regenerative Medicine
supports research and practice to
advance therapies like modern hip decompression surgery that restore form and
function to diseased cells, tissue or organs.

###

Links to Dr. Sierra’s
research:

Facts about avascular necrosis
On average 6 out of 100 people on steroid therapy will develop avascular necrosis

Risk factors:
Radiation
Steroid therapy
Sickle cell disease
Pancreatitis
Alcohol abuse
High cholesterol
Smoking
Research is probing whether there is an underlying genetic mutation linked to the disease. 

Thu, Mar 12 8:15am · Mayo Clinic research discovers how stem cells repair damage from heart attacks

Mayo Clinic researchers have uncovered stem cell-activated mechanisms of healing after a heart attack. Stem cells restored cardiac muscle back to its condition before the heart attack, in turn providing a blueprint of how stem cells may work.

The study, published in NPJ Regenerative Medicine, finds that human cardiopoietic cells zero in on damaged proteins to reverse complex changes caused by a heart attack. Cardiopoietic cells are derived from adult stem cell sources of bone marrow.

Andre Terzic, M.D., Ph.D.

“The
extent of change caused by a heart attack is too great for the heart to repair
itself or to prevent further damage from occurring. Notably, however,
cardiopoietic stem cell therapy reversed, either fully or partially, two-thirds
of these disease-induced changes, such that 85% of all cellular functional
categories affected by disease responded favorably to treatment,” says Andre Terzic, M.D.,
Ph.D.,

director of Mayo Clinic’s Center for
Regenerative Medicine
.
Dr. Terzic is the senior author of the study.

This
new understanding of how stem cells restore heart health could provide the
framework for broader applications of stem cell therapy across various
conditions.

“The
actual mode of action of stem cells in repairing a diseased organ has until now
been poorly understood, limiting adoption in clinical care. This study sheds
light on the most intimate, yet comprehensive, regenerative mechanisms ― paving
a road map for responsible and increasingly informed stem cell application,”
says Dr. Terzic.

Heart disease is a leading cause of death in the U.S. Every 40 seconds, someone in the U.S. has a heart attack, according to the Centers for Disease Control and Prevention.  During a heart attack, cardiac tissue dies, weakening the heart.

Kent Arrell, Ph.D.

“The
response of the diseased heart to cardiopoietic stem cell treatment revealed development
and growth of new blood vessels, along with new heart tissue,” adds Kent
Arrell, Ph.D., a Mayo Clinic cardiovascular researcher and first author of the
study.

The research

Researchers
compared the diseased hearts of mice that did not receive human cardiopoietic
stem cell therapy with those that did.  Using
a data science approach to map all the proteins in the heart muscle, researchers
identified 4,000 cardiac proteins, more than 10% of which suffered damage by a
heart attack.

“While
we anticipated that the stem cell treatment would produce a beneficial outcome,
we were surprised how far it shifted the state of diseased hearts away from
disease and back toward a healthy, pre-disease state,” says Dr. Arrell.

Cardiopoietic stem cells are being tested in advanced clinical trials in heart patients.

“The
current findings will enrich the base of knowledge pertinent to stem cell
therapies and may have the potential to guide therapeutic regimens in the
future,” says Dr. Terzic.

This
study was made possible by funding from National Institutes of Health grants R01 HL134664 and T32
HL07111, Regenerative
Medicine Minnesota

grant 021218BT001, the Marriott Family Foundation, the Van Cleve Cardiac
Regenerative Medicine Program, the Michael S. and Mary Sue Shannon Family, and
Mayo Clinic’s Center for Regenerative Medicine.

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

###

About Mayo Clinic’s Center for
Regenerative Medicine

Mayo Clinic’s Center for Regenerative Medicine seeks
to integrate, develop and deploy new regenerative medicine products and
services that continually differentiate Mayo’s practice to draw patients from
around the world for complex care. Learn more on Mayo
Clinic’s Center for
Regenerative Medicine website
.


About Mayo Clinic

Mayo Clinic is a nonprofit organization committed to innovation in clinical
practice, education and research, and providing compassion, expertise and
answers to everyone who needs healing. Visit the Mayo Clinic News Network For additional
Mayo Clinic news and An Inside everyone who needs
healing. Visit the Mayo
Clinic News Network
for additional Mayo Clinic news and An Inside Look
at Mayo Clinic
for more information about Mayo.

Thu, Feb 20 9:00am · Patient consults: finding the best treatment option for each individual

Is regenerative medicine in your future or would standard procedures be the best remedy for diseases like arthritis? Mayo Clinic’s Regenerative Medicine Consult Service helped two men with a similar disease choose two vastly different paths to healing based on their individual conditions and lifestyles.

79-year old Joe Rosinski, a retired Ford motor company
engineer, came to Mayo Clinic’s Jacksonville, Florida campus seeking relief for
osteoarthritis in the knee. Active in weight lifting and team sports well into
his 60’s, Rosinski was sidelined by extreme pain. He could no longer whisk his
bride of 50 years across the dance floor, a favorite hobby.

“I had bone-on-bone in both knees. Pain from arthritis was
really rough for quite a few years. I was putting off and putting off treatment
for quite a few years. It had come to a point that I had slowed down to minimal
activities,” says Rosinski.

68-year old John Simpson, a retired grape farmer from
California had a similar ailment. He enjoyed helping his daughter on her own
Texas ranch but had trouble keeping up with the work and his
grandchildren.  Arthritis, he says, had gotten
so bad that he could barely walk.

“I
travel at the airport a lot, and it was to the point that I couldn’t hardly
walk from one gate to another if it was more than six or eight Gates away. My
knees were worn
out on the insides,” says Simpson.

Simpson,
a survivor of both colon and prostate cancer, had built a strong relationship
with medical providers at Mayo Clinic’s Arizona campus, where he had his cancer
treated. When he heard about new regenerative procedures that might heal without
surgery, he returned to Mayo Clinic again – this time to Mayo Clinic’s
Regenerative Medicine Therapeutics Suites
in Florida. Those procedures are
also known as orthobiologics – substances found in the patient’s own body that musculoskeletal
specialists sometime use to assist with healing.

Regenerative Medicine
Consult Service

Regenerative medicine is an emerging area of practice that seeks
to tap the body’s ability to heal itself, restoring form and function to
diseased tissues, cells and organs. As with anything new, there is hope and
there is hype. So, how do patients separate the science from science fiction
when it comes to care?

Mayo Clinic’s Regenerative Medicine Consult Service seeks to
educate patients and help them understand the proven versus what is unknown and
the risks and benefits of different options. 
All patients seeking regenerative care at the Regenerative Medicine Therapeutic
Suites are given thorough examinations and a 30-minute patient consult.

Shane Shapiro, M.D.

“We look at their X-rays, and I examine their knee and we determine
whether or not they have osteoarthritis. The next part of the consult is a
discussion about the standard of care treatment. We advocate for standard of
care first,” says Shane
Shapiro, M.D.
, medical director of Mayo Clinic’s Regenerative Medicine
Therapeutic Suites. “We don’t recommend any one treatment over another.”

The patient and provider then discuss treatment options
–whether that’s routine clinical care or regenerative procedures. Together,
they decide how to proceed.

“At Mayo Clinic, the regenerative treatments we offer are
grounded in scientific research. We always talk to patients about the full
range of medical options appropriate for their specific condition or symptoms,”
says Dr. Shapiro, who is also an associate professor and consultant in the Mayo
Clinic Department of Orthopedic Surgery.

Regenerative medicine treatments are sometimes an option
when standard treatment does not meet the patient’s needs. However, they are
not a miracle cure and may not be appropriate for each person.

Through the consult service, providers help patients understand
their choices and may refer them to standard treatments throughout Mayo Clinic,
depending on diagnosis and therapeutic needs. 

Same Disease, Different
Choices

Though both Joe Rosinski and John Simpson suffered from osteoarthritis
in their knees, they took different therapeutic paths.  Mr. Rosinski chose standard knee replacement
surgery, because of the advanced stage of his condition.

“They told me my disease had progressed to the point that
stem cell procedures were not going to work for me,” says Rosinski. “They said,
‘I’m not going to be the one to tell you when I need a knee replacement. You are
going to be the one to tell us when you can’t take the pain anymore.’” 

He had knee replacement surgery shortly after the consult,
and is now able to walk without knee pain.

John Simpson came to Mayo seeking a regenerative procedure
known as micro-fragmented adipose tissue. This is a procedure using a Food and
Drug Administration approved device to harvest a patient’s own adipose (fat)
tissue for injection into affected joints. After his consult, Simpson learned
that based on his condition, he was a good candidate for micro-fragmented
adipose tissue injection. He chose to pay out of pocket for the option of
avoiding surgery on his right knee.

“My
goal was to avoid a knee replacement. All I know is my right knee is way much
better than it has been for a lot of years. Now I can make my way around the
airport without any problem at all,” says Simpson.

“I was
planning on having my right shoulder injected with adipose tissue, but I
learned the problem was with my socket, not the arthritis. Dr. Shapiro said this
was not the right procedure for my shoulder, so we decide on a cortisone
steroid shot, which helped relieve my pain,” he says.

Simpson is satisfied with his choices and plans to have micro
fragmented adipose tissue injections in left knee as well.

Mayo Clinic is following patients who choose this procedure for two years to monitor tissue healing. Researchers are studying the evidence on micro-fragmented adipose tissue injections and other regenerative medicine procedures to better understand effectiveness. This data is used to inform patients and to supplement information learned through clinical trials:

  • At Mayo Clinic, we encourage standard treatments
    as first consideration for musculoskeletal conditions. However, orthobiologic
    procedures can be potentially complementary serving to fill a crucial treatment
    gap that exists once patients have exhausted standard of care options including
    activity modification, physical therapy, anti-inflammatory regimens, steroid
    injections and before patients are ready to consider a surgery like joint
    replacement.
  • Mayo Clinic experts join colleagues around the
    field of orthopedic surgery in the shared goal of addressing patients’ unmet
    needs by advancing novel orthobiologic therapies and their potential to lessen
    pain, improve function and quality of life.

Mayo Clinic Regenerative Medicine Consult Service seeks to
empower patients with information to make the right choice for their care. Consultations
may also take place over the phone for people who are looking for information
and resources about regenerative medicine. Regenerative medicine procedures are
available on all three Mayo Clinic campuses. For more information on the Mayo
Clinic Regenerative Medicine Therapeutic Suites call 904-953-0853. For general
education questions about regenerative medicine, call 1-844-276-2003.

###

Learn more
about Dr. Shapiro’s research:

Thu, Jan 23 9:18am · Mayo Clinic Regenerative Medicine on the International Stage

Mayo Clinic experts are sharing their leadership and knowledge of regenerative medicine with an international audience at the World Stem Cell Summit in Miami. Every year more than 2,000 physicians, scientists, bioethicists, industry, government watchdogs and patient advocates from 44 countries convene at the World Stem Cell Summit to collaborate and focus on ways to advance emerging regenerative sciences. 

Shane Shapiro, M.D.

“This conference attracts some of the
most preeminent minds in regenerative medicine and is representative of the field’s
eco system.  It’s a chance to share our
latest research and newest applications of validated regenerative procedures,” says
Shane Shapiro, M.D., medical director of Mayo Clinic Center for Regenerative Medicine Therapeutic
Suites
at Mayo’s Jacksonville, Florida
campus.

Dr. Shapiro moderated three different
sessions at this year’s World Stem Cell Summit focusing on:

  • The latest 
    validated regenerative applications to patient care
  • Regulatory guidelines  and identifying safe and trusted procedures
  • Legal and ethical issues in regenerative
    medicine

Regenerative medicine is redefining
health care with a focus on the body’s ability to heal itself.  Regenerative therapies aim to restore form
and function to diseased cells, tissues, or organs — and ultimately to the individual as a whole.  Mayo Clinic is a leader in bringing the
promise of regenerative medicine to patients everywhere through research,
clinical trials and application to patient care.

Mayo Clinic speakers share their
knowledge in the following presentations:

Carmen Terzic, M.D., Ph.D.

Carmen Terzic, M.D., Ph.D., a physiatrist and chair of Mayo Clinic
Physical Medicine and Rehabilitation leads research on directing stem cells
toward the formation of new heart tissue — known
as cardiogenesis  — to restore function lost to damaged tissue.  Dr. Terzic presented on her research in
cardiogenesis and its potential is to establish cardiovascular regenerative
medicine as the new standard of care for heart disease. She also spoke about
stem cells and exercise

Zubin Master, Ph.D.

Zubin Master, Ph.D., a bioethicist for Mayo Clinic Center for Regenerative Medicine, shared his research that reveals consumers are seeing a barrage of misinformation around stem cells and regenerative medicine.  Dr. Master presented data on the demographic groups that are most likely to be seeking regenerative medicine and how they are looking for credible information to make better decisions on their care.

Quinn Peterson, Ph.D.

Quinn Peterson, Ph.D.,  a scientist in Mayo Clinic’s Islet Regeneration Program, lectured on efforts to generate engineered islets that could be used as a therapy for type 1 diabetes. Islets are clusters of cells in the pancreas that produce hormones. Dr. Peterson’s research seeks to discover whether transplantation of engineered islets may restore the body’s ability to produce insulin and regulate blood glucose in patients with type 1 diabetes.

Wenchun Qu, M.D., Ph.D.

Wenchun Qu, M.D., Ph.D., a physiatrist and pain specialist with a special interest in regenerative medicine, leads research on mesenchymal stem cells (MSC) – adult stem cells that can produce several types of cells in the musculoskeletal system such as skeletal tissue, cartilage, bone and fat.  Dr. Qu’s lecture focused on the progress of MSC therapy trials at Mayo Clinic that seek to restore form and function.

Mayo
Clinic Center for Regenerative Medicine
is a co-sponsor of this year’s
World Stem Cell Summit.

###

Fri, Jan 10 9:15am · Mayo Clinic Research Discovers a Molecular Switch for Repairing Central Nervous System Disorders

A molecular switch has the ability to turn on a
substance in animals that repairs neurological damage in disorders such as multiple
sclerosis (MS)
, Mayo Clinic
researchers discovered. The early research in animal models could advance an
already approved Food and Drug Administration therapy and also could lead to new
strategies for treating diseases of the central nervous system.

Research
by Isobel
Scarisbrick, Ph.D.
, published in the Journal of Neuroscience
finds that by genetically switching off a receptor activated by blood proteins,
named Protease Activated Receptor 1 (PAR1), the body switches on regeneration
of myelin, a fatty substance that coats and protects nerves.

Isobel Scarisbrick, Ph.D.

“Myelin
regeneration holds tremendous potential to improve function. We showed when we
block the PAR1 receptor, neurological healing is much better and happens more
quickly. In many cases, the nervous system does have a good capacity for innate
repair,” says Dr.
Scarisbrick, principal investigator and senior author. “This sets the
stage for development of new clinically relevant myelin regeneration strategies.”

Myelin,
Thrombin and the Nervous System

Myelin acts like a wire
insulator that protects electrical signals sent through the nervous system.
Demyelination, or injury to the myelin, slows electrical signals between brain
cells, resulting in loss of sensory and motor function. Sometimes the damage is
permanent. Demyelination is found in disorders such as MS, Alzheimer’s disease, Huntington’s disease, schizophrenia and spinal cord injury.

Thrombin is a
protein in blood that aids in healing. However, too much thrombin triggers the
PAR1 receptor found on the surface of cells, and this blocks myelin production.
Oligodendrocyte
progenitor cells capable of myelin regeneration are often found at sites of
myelin injury, including demyelinating injuries in multiple sclerosis.

“These oligodendroglia fail to differentiate into mature
myelin regenerating cells for reasons that remain poorly understood,” says Dr. Scarisbrick. “Our research identifies PAR1 as a molecular switch of myelin
regeneration. In this
study, we demonstrate that blocking the function of the PAR1, also referred to
as the thrombin receptor, promotes myelin regeneration in two unique
experimental models of demyelinating disease.”

The Research

The research
focused on two mouse models. One was an acute model of myelin injury and the
other studied chronic demyelination, each modeling unique features of myelin
loss present in MS, Alzheimer’s disease and other neurological disorders.  Researchers genetically blocked PAR1 to block
the action of excess thrombin.

The research not
only discovered a new molecular switch that turns on myelin regeneration, but also
discovered a new interaction between the PAR1 receptor and a very powerful
growth system called brain derived neurotropic factor (BDNF). BDNF is like a
fertilizer for brain cells that keeps them healthy, functioning and growing.

Significantly, the
researchers found that a current Food and Drug Administration-approved drug
that inhibits the PAR1 receptor also showed ability to improve myelin production
in cells tested in the laboratory.

“It
is important to say that we have not and are not advocating that patients take
this inhibitor at this time,”
says Dr. Scarisbrick. “We
have not used the drug in animals yet, and it is not ready to put in patients
for the purpose of myelin repair. Using cell culture systems, we are showing
that this has the potential to improve myelin regeneration.”

Additional research
is needed to verify and advance the findings toward clinical practice.

The study was made
possible by a grant from the National Multiple Sclerosis Society with support from the Mayo Clinic Rehabilitation Medicine
Research Center, the Center for Multiple Sclerosis and Autoimmune Neurology and
the Mayo Clinic Center for Regenerative Medicine.

###

Dec 26, 2019 · Top ways regenerative medicine is advancing the health care of tomorrow for patients today

Regenerative medicine accelerated from the bench into the practice in new ways in 2019, ushering in an era of care focused on the body’s amazing ability to heal itself. Bolstered by robust research, Mayo Clinic is at the forefront of delivering new therapies that restore form and function to diseased cells, tissues, or organs — and ultimately to the individual as a whole. 

Andre Terzic, M.D., Ph.D.

“The regenerative toolkit keeps on expanding concomitantly, and applications of regenerative medicine into practice is increasingly broadening to more conditions that benefit more patients. Across Mayo Clinic sites and specialties, from neurosurgery, neurology, otorhinolaryngology, pulmonary medicine, cardiology and cardiac surgery to cancer and musculoskeletal care, women’s health and plastic surgery, medicine, laboratory medicine and radiology, this year has seen remarkable achievements,” says Andre Terzic, M.D., Ph.D., director of Mayo Clinic Center for Regenerative Medicine. 

Redefining health care

Regenerative medicine is redefining clinical care, going beyond mitigating
disease symptoms to addressing the underlying cause. Mayo Clinic aspires to
cure, connect and transform through new regenerative therapies grounded in rigorous
science and in line with regulatory standards for quality and
compliance.

Within the next decade, regenerative medicine is predicted to account
for 10% of all clinical care. As a prelude to the years to come, Dr. Terzic points
to inspiring examples that have highlighted regenerative care in 2019 at Mayo
Clinic:

Regenerative
immunotherapies are transforming cancer care

Mayo Clinic is one of a few select medical centers in the United States to provide chimeric antigen receptor (CAR) T-cell therapy  in a clinical setting.  CAR T-cell therapy unleashes the body’s immune system to go on search and destroy missions, targeting blood cancers, particularly B-cell leukemias and lymphomas.  In the past year, the number of clinical trials involving CAR T-cell therapy has doubled; there are two newly approved drug options offered for leukemia and lymphoma; and additional new therapies are expected to clear U.S. Food and Drug Administration approval in early 2020.

Neurosurgery is
offering new hope for spinal cord injury

Early
research
at Mayo Clinic shows that stem cell intervention in the lumbar, or
lower back, offers hope for people paralyzed from spinal cord injury. A Mayo
Clinic case study found mesenchymal stem cells derived from a patient’s own fat
injected after standard surgery and physical and occupational therapy restored bodily
function in the first person tested. The patient, a 53-year-old man paralyzed
in a surfing accident, has shown significant gains in standing, walking and
gripping strength.

A second surgical procedure is referred to as spinal cord
bypass.  An implanted stimulator bypasses
the area of spinal injury, restoring the body’s ability to send messages to and
from the brain.  Mayo Clinic research has shown
this type of spinal cord stimulation helped a man paralyzed since 2013 regain ability
to stand and walk with assistance, regenerating information flow around the
severed lesion.

Larynx and lymph node
transplant: breakthroughs in regenerative surgery

Mayo Clinic launched a first of its kind transplant program
in its Arizona Otorhinolaryngology practice to restore function for people that
have had their larynx, or voice box, removed.  The United Network for Organ Sharing (UNOS)
has given its first approval for this procedure to Mayo Clinic. A successful
larynx transplant allows a patient to breathe through the mouth, swallow
normally and produce a human-sounding voice instead of breathing through an
opening in the neck and communicating by machine or special prosthesis.

“This formidable achievement underscores the collective
ability of Mayo Clinic to not only advance innovation but to do it in a way
that is systematic and meets the highest stringency for bringing a concept into
the practice,” says Dr. Terzic.

Concomitantly, in Plastic Surgery, lymph node transplants are showing promise as a therapy for lymphedema — a painful blockage of the lymph system that causes fluid buildup commonly seen in patients treated for breast cancer. Healthy lymph nodes are transplanted to replace the diseased counterparts, promoting regrowth of the lymph system.  

New procedures in
maternal fetal medicine enable correction before birth

Initially it was thought that regenerative medicine would
mainly address issues related to diseases of aging. However, research at Mayo
Clinic increasingly shows that regenerative medicine interventions can tap the
strong healing abilities of a young child or even be beneficial prior to birth.

Two recent examples of fetal surgeries led by a Gynecology
and Obstetrics specialist and performed at Mayo Clinic through U.S. Food &
Drug Administration-approved clinical trials include:

Fetal endoscopic trachea occlusion surgery  which seeks to correct underdeveloped lungs caused by severe congenital diaphragmatic hernia (CDH) — a condition in which internal organs push up against developing lungs, stunting growth. Without this surgery, 70% of infants born with severe CDH die. The surgeon places a balloon in the fetus’s trachea, causing the lungs to regrow and expand enough for the baby, at birth, to eventually breathe without assistance.

Minimally
invasive fetoscopic repair of spina bifida
 
is another procedure under clinical assessment done in the second trimester
of pregnancy to repair a birth defect that occurs when the spine and spinal
cord don’t form properly.

Areas of advancements to watch in 2020

  • Regenerating organs for transplantation — Research at Mayo Clinic’s Florida campus will seek to address the shortage of donor organs by regenerating or rebuilding the health of organs previously considered not viable for transplantation.  
  • Biomanufacturing new products that promote healing — Mayo Clinic has a targeted investment in biomanufacturing of new cellular, acellular and tissue products that offer patients new options for healing. Opportunities to scale production for increased accessibility, affordability and cure rates are prioritized.
  • Educating the workforce of the future —Mayo Clinic is training the next generation of physician-scientists through regenerative medicine curricula that transcends the educational shield. Efforts are underway to develop a dedicated regenerative science track at the graduate school level and to train all medical students to become proficient in regenerative medicine.
  • Developing industry collaborations to speed new therapies to market  Mayo Clinic is forging new industry collaborations to bring to market new regenerative therapies for the benefit of patients around the world.

“It is an exciting time as regenerative medicine applications
continuously expand across disease conditions,” says Dr. Terzic.  “Regenerative medicine is driven by patients
seeking regenerative solutions. Therefore, we have a moral and societal mandate
to ensure the validity and ultimately the utility of these newest therapies.”

Mayo Clinic will continue to advance its regenerative
care  toolkit to address unmet needs of
the patient  and to advance Mayo Clinic’s
vision  to “cure, connect, and transform”
health care in 2020 and beyond.

###

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.

Nov 27, 2019 · Mayo Clinic research is a step toward hope for spinal cord injuries

Early research published in Mayo Clinic Proceedings examines the first case at Mayo Clinic of stem cell therapy tested in humans for spinal cord injury. The case study found stem cell intervention, which took place after standard surgery, and physical and occupational therapy, restored some function in a patient with spinal cord injury. The report, “Celltop Clinical Trial: First Report From a Phase I Trial of Autologous Adipose-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury” is published in the Nov. 27, 2019 edition of Mayo Clinic Proceedings.

The research discusses the experience related to the first case in a phase I safety study of mesenchymal stem cell treatment for spinal cord injury. Mohamad Bydon, M.D., a Mayo Clinic neurologic surgeon and the lead author, cautions that each patient is different, so it’s too early to consider stem cell therapies as a treatment or cure for paralysis from spinal cord injury. Dr. Bydon adds that much like early trials in general, the stem cell trials are going to show variable response rates.

Mohamad Bydon, M.D.

“While
in this case, the first subject was a superresponder, others may not respond in
the same manner. We do not yet understand all of the necessary biology needed
to achieve neurological recovery in paralyzed individuals,” says Dr.
Bydon. “One of our objectives in this study and future studies is to
better delineate who will be a responder and why patients respond differently.”

The research

The research centers on a 53-year-old man who suffered a spinal cord injury in a surfing accident that left him paralyzed below the neck. The patient had immediate improvements with standard therapy, but plateaued at six months post-injury. Researchers enrolled the patient in the study at Mayo Clinic nine months after the accident and injected the patient with stem cells 11 months after injury. After the stem cell injection, the patient significantly improved motor and sensory function.

The
case study focuses on feasibility, safety and dosing of stem cell therapy. The
study team derived mesenchymal stem cells from the patient’s fat cells and
injected them into the lower back in a procedure known as lumbar puncture.

Dr.
Bydon; Wenchun Qu,
M.D., Ph.D.
,
a physical medicine and rehabilitation physician; and Allan Dietz,
Ph.D.
,
a transfusion medicine physician, led the multidisciplinary research team at
Mayo Clinic.

Wenchun Qu, M.D., Ph.D.

“Severe
spinal cord injury is a devastating condition for which scientists and
physicians are trying to find a cure. For the first time, we are inspiring hope
that people may receive better recovery in their function and quality of life,”
says Dr. Qu. “Mayo Clinic has been taking the lead in translating the
fruits of decades of research and treating neurological conditions, among which
have been very important clinical trials where we evaluate the safety,
feasibility and efficacy of adult stem cells for severe spinal cord injuries.”

Allan Dietz, Ph.D.

“This work both demonstrates the ability of cells to initiate repair and capitalizes on more than 10 years of work in the Immune, Progenitor and Cell Therapeutics Lab at Mayo Clinic. While there is still much to learn about the amazing ability of cells to heal tissue, this trial is an important step in advancing cell-based therapies toward clinical practice,” says Dr. Dietz.

Investigators
collected cerebrospinal fluid to look for new biological markers that might
give clues to healing. Biological markers are important because they can help
identify the critical processes that lead to spinal cord injury at a cellular
level and could lead to new regenerative therapies.

Further
study is needed to understand the effectiveness of stem cell lumbar injections
and why patients may respond differently.

Currently,
there is no way to reverse the devastating life-changing effects of paralysis
from spinal cord injuries. Today, the only treatment is supportive care, such
as surgery and physical and occupational therapy.

Dr.
Bydon says his early findings give hope that new regenerative therapies are on
the horizon for spinal cord injuries.

“The
hope is that we will have novel treatments for spinal cord injuries in the coming
years that will be different from what we have today. These will be therapies that
do not rely upon supportive care, but therapies that rely on science to create
a regenerative process for the spinal cord,” says Dr. Bydon.

This research was made possible by funding from Mayo Clinic Transform the Practice Initiative and Regenerative Medicine Minnesota with support from the Mayo Clinic Center for Regenerative Medicine and the Department of Laboratory Medicine and Pathology Immune, Progenitor and Cell Therapeutics lab. The Transform the Practice Initiative aims to foster multidisciplinary teams of clinicians and researchers who align discovery and translational science, create new capacities and achieve solutions that improve the practice and address the unmet needs of patients.

###

Read the news release

Oct 1, 2019 · Zane's story: Fetal surgery to expand lungs

Zane Fouts with parents Trevor Fouts,
Alyse Ahern-Mittelsted

Baby Zane Fouts’ boundless curiosity starts at his feet, which
he grabs and plays with happily. The energetic boy who’s full of smiles is a
trailblazer for regenerative surgery performed in a clinical trial at Mayo Clinic even before birth.

“He’s our miracle baby,” says his mother, Alyse Ahern-Mittelsted.  “He’s a rock star.”

Ahern-Mittelsted was 20 weeks pregnant when an ultrasound showed Zane had severe congenital diaphragmatic hernia (CDH). This life-threatening condition blocks lungs from growing enough for babies to breathe on their own. Without intervention, 70% of infants born with severe CDH die. The bombshell news came less than a year after Ahern-Mittelsted unexpectedly lost a daughter at 31 weeks of gestation to a different condition — a failed placenta.

“We thought we were going to lose another baby. We were
really scared.”

CDH is a hole in the muscle separating the chest and abdomen.
That causes the spleen, stomach and bowels to push up into the chest cavity and
stunt lung growth. The result is small, underdeveloped lungs, known as pulmonary
hypoplasia
.  It’s a rare condition that
affects 1 in 10,000 babies.

To try to save Zane’s life, Rodrigo Ruano, M.D., Ph.D., head of Maternal Fetal Medicine at Mayo Clinic, recommended fetal endoscopic trachea occlusion surgery while Zane was still in the womb.

Rodrigo Ruano, M.D., Ph.D.

“It’s a delicate procedure. We insert a 3-to-4 millimeter telescope through the mother and into the fetus. We advance a balloon into the baby’s mouth and detach it from a catheter placed inside the trachea, which is the airway of the fetus. The goal of this surgery is to regenerate and expand the lungs,” says Dr. Ruano.  “I feel so passionately about this surgery that I have dedicated my life to moving it toward standard of care treatment.”

When the balloon inside the fetus’ trachea inflates, it
fills the lungs with fluid, potentially causing the lungs to expand and grow. Because
a fetus breathes through the placenta, the balloon does not choke the baby.

Dr. Ruano is pioneering this procedure at Mayo Clinic
through U.S. Food and Drug Administration (FDA) -approved clinical trials with
support from the Mayo
Clinic Center for Regenerative Medicine
and a grant from Regenerative Medicine Minnesota.

While the surgery shows promise, it also comes with risk of preterm
labor and delivery. That meant the young couple from Cresco, Iowa, had a
decision to make about the health of their unborn child.

“We were told that without the surgery, our baby would only
have a 25% chance of ever coming home. With the surgery, the chances jumped to
75%,” says Ahern-Mittelsted. “We knew there was a chance this surgery might not
work. But, if this was going to give our son the best chance of survival, I
wasn’t going to second guess it.”

“After the doctor told us our options, I was looking for
more information (to help make a decision.) I looked online, but this procedure
is so new, there wasn’t a lot about it. I had to put my faith and trust in our
surgeon,” says Trevor Fouts, Zane’s father.

Surgery to place the balloon inside Baby Zane’s trachea was
performed at 27 weeks under local anesthesia and took only about 15 minutes.  

“When they were going to place the balloon, they had to move
the baby and place him in the right position. That was painful for me, but it
went fast,” she adds.

The balloon was removed at 34 weeks of pregnancy, and Zane
was born full-term at 39 weeks. How well a baby with Zane’s condition does at
birth depends on development of the lungs. Some babies whose lungs successfully
grow and develop may recover with few lingering medical issues. Others whose
lungs do not respond as well may have mild to long-term handicaps.

Immediately after birth, a breathing tube was placed in
Zane’s airway and he was connected to a ventilator. But, he was only on
machine-assisted breathing for a couple of weeks.

The balloon surgery expanded his lung capacity by about 60%.
After 52 days in the Neonatal Intensive Care Unit, he had improved enough to go
home.

Zane Fouts

“Without this procedure he likely would not have been as
healthy as he is now.  He still has a
raspy voice and has a tough time with coughs. Eventually, we expect him to live
a normal life with normal activities.  We
think he’ll be able to participate in sports, although he may need an inhaler,”
says Ahern-Mittelsted.  “I believe this
surgery pretty much saved his life.”

Dr. Ruano has performed a total of five fetal endoscopic
trachea occlusion surgeries so far at Mayo Clinic. His research team is
compiling the data to establish whether this surgery improves chances for survival
and reduces recovery time. The long-term goal is to secure FDA approval of the
balloon used in the procedure so this surgery can be offered in daily clinical
care.

Read about Dr. Ruano’s research on fetal endoscopic trachea occlusion surgery.

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