Posts (161)

Tue, Jul 30 9:32am · Bioartificial Liver: Bridge to Liver Regeneration

The liver has the greatest regenerative capacity of any
organ in the body. However, when the liver is injured beyond its ability to
regenerate itself, and a transplant is not readily available, there are few
options for patients.

Scott Nyberg, M.D., Ph.D.

Led by Scott
Nyberg, M.D., Ph.D.
, researchers are refining their own version of a
bioartificial liver, known as the Spheroid Reservoir Bioartificial Liver (SRBAL).
This device contains pig liver cell (hepatocyte) spheroids, which replace a
patient’s liver function.

“Ideally, the
artificial liver would bridge the gap until a donor liver becomes available or
if it could help the patient avoid the need for a transplant altogether,” says
Dr. Nyberg.

While the artificial liver device has been successfully
demonstrated
on pigs with acute liver failure, the ultimate goal is the bedside
treatment of patients in liver failure. With a research grant from Regenerative Medicine Minnesota, Dr.
Nyberg and his team are continuing to study whether the artificial liver could
function similar to a kidney
dialysis machine. The patient would be connected to the device, and much like
dialysis, the artificial organ would, perform critical bodily functions
while the liver heals and regenerates.

“The results of our third large animal study were published in
January
2019
,” says Dr. Nyberg. “Pigs were chosen for the early studies because
their metabolism is similar to ours and because they could provide an abundant
supply of liver cells.”

In the treatment group, all of the animals survived the
therapy and were up walking around with recovered livers at the end of the
study. The results have paved the way for future clinical trials.

Schematic of the extracorporeal circuit of the Spheroid Reservoir Bioartificial Liver

 Although
the SRBAL is similar to kidney dialysis, the liver is more complicated. It does
metabolic activities, detoxifies wastes, and synthesizes proteins. Because of
this, the SRBAL incorporates living cells– in this case, from pig livers – to
carry out such vital functions for a patient.

“We’re ready for to move into Phase I trials in humans,”
says Dr. Nyberg. “However, funding a medical device trial using living cells in
humans is quite expensive, and we’ll need to build a new clinically acceptable
SRBAL suitable for human use.”

Once funding is established and the new device developed,
the first study in humans would be a Phase I safety study to make sure the
machine is safe for use on people. Second is a dosing study to determine the
efficient dose of liver cells to put in the bioreactor to repair the liver.
Once the Phase I and Phase II studies are complete and encouraging, a Phase III,
multicenter randomized study would follow.

“This
is an exciting time for transplant surgery,” says Charles Rosen, M.D., director of the William J. von
Liebig Center for Transplantation and Clinic Regeneration at Mayo Clinic. “The
need for organ donation is high, and this research couldn’t come at a better
time.”

SRBAL would be most appropriate for patients who have acute
liver failure and are awaiting transplant, experience an overdose of
medication, or those who aren’t candidates for liver transplant.

“There’s a lot of work to be done, but this is a promising
solution to the donor organ shortage in some cases” says Dr. Nyberg. “Many acute
liver failure patients would have the opportunity to recover, if only they had
time for their liver to regenerate and heal.”

Fri, Jul 26 12:19pm · Research for Infants with HLHS Moves Forward

Hypoplastic left
heart syndrome
 (HLHS) is a complex and rare heart defect
present at birth in which the left side of a child’s heart is severely
underdeveloped. At Mayo Clinic, physicians and researchers in the Todd and Karen Wanek
Family Program for Hypoplastic Left Heart Syndrome
are looking for ways to
delay or even prevent heart failure for people with HLHS.

The program has launched clinical trials using a patient’s
own stem cells with the goal of strengthening the heart. One of the clinical
trials uses stem cells collected from a baby’s own umbilical cord blood banked
with the program. The stem cells are injected into the baby’s heart during the second of three surgeries.

The phase I clinical trial is the first research monitored by
the Food and Drug Administration that demonstrates the potential of
regenerative therapy for HLHS
through collecting, processing and injecting an infant’s own stem cells
directly into the heart at the time of surgery.

Stem cell therapy 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.

Read the full news release on the Mayo Clinic News
Network
.

Fri, Jul 19 10:39am · 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.

Fri, Jun 28 3:09pm · 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.”

Mon, Jun 24 10:45am · 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 yearHLHS 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.

Read more information and the full HLHS Consortium announcement on the Mayo Clinic News Network.


[i] Center for Disease Control and Prevention Facts about Hypoplastic Left Heart Syndrome

Fri, Jun 21 10:54am · 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.

Wed, May 29 6:00pm · Mayo Clinic Course Addresses Education Gap: Building the Regenerative Medicine Workforce

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.

Fri, May 17 12:43pm · 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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