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Big House, Big Heart

Annual fundraiser at Michigan Stadium draws 10,000

Even a rainy day cannot dampen the spirits of those truly inspired to make a difference for their favorite charities!

About 10,000 participants braved thunderstorms on April 15 to run, walk or wheel toward the finish line inside Michigan Stadium. Organizers say the 5K alone had over 7,000 people running in it.

Taubman Institute Director Dr. Eva Feldman's lab won the university's Go Blue! Challenge for best participation in the medical center division! Thanks to all who contributed to ALS research and other good causes.


Braylon Edwards Foundation Celebrity Basketball Game

Thanks to the support of sponsors, players and fans, the 2nd Annual Braylon Edwards Foundation Celebrity Basketball game was a big hit.

Not only was the event fun and exciting, it benefitted U-M researchers racing toward a treatment for ALS.

Amyotrophic lateral sclerosis – also known as Lou Gehrig’s disease – is a terrifying and fatal condition that currently has no cure. It progressively destroys the nerves that control voluntary muscle movement, leaving patients unable to move, speak and ultimately unable to breathe. Scientists are focusing their attention on the disproportionate number of athletes who have the disease – like its most famous sufferer, baseball great Lou Gehrig – and have uncovered evidence that sports-related head injuries may be connected to onset.

Funding from the Braylon Edwards Foundation will help Dr. Feldman to continue this groundbreaking ALS research.


FDA approves next step in stem cell trial directed by Taubman Institute’s Dr. Eva Feldman

The Food and Drug Administration has approved the next phase of a clinical trial of stem cell therapy for ALS patients being conducted by Eva Feldman, M.D., Ph.D., director of the A. Alfred Taubman Medical Research Institute.

In the trial’s first phase, Feldman and her collaborators injected stem cells into the lumbar area of spinal cords of 12 patients with amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease). There have been no adverse side effects related to the procedure.

Going forward, the FDA has approved administering the injections into the cervical region of patients’ spines.

“We have been very encouraged by the early transplantations,” said Eva Feldman, MD, PhD, Principal Investigator of the trial and an unpaid consultant to Neuralstem “Cervical injections are essential, because therapy in this region is key to helping patients with their breathing. The deterioration of these functions most dramatically affect the patients’ quality of life and ultimately their life expectancy.”

Dr. Feldman is the Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System.

The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The procedures are taking place at Emory University.

Data recently presented to the FDA on the first 12 patients showed that eight out of ten living subjects in the trial had lower extremity function scores that remained the same or improved after treatment. Two out of ten showed continued decline of lower extremity function.

The trial will now progress to cervical spine injections. The first three of these will receive unilateral injections in the cervical region of the spine. The next three will receive bilateral injections in the cervical region.

For additional information, see the Neuralstem press release.


Taubman Emerging Scholar Dr. James Dowling Wins $350,000 Grant

Dr. James Dowling, director of the U-M Muscular Dystrophy Clinic, has been awarded a $350,000 grant from the Muscular Dystrophy Association.

The group said it made the award to support Dowling's research into potential therapies for myotubular myopathy, a disease that affects skeletal muscles and also leads to respiratory problems and eye-muscle weakness.

Dowling is the Taubman Institute's Frances and Kenneth Eisenberg Emerging Scholar and an assisistant professor of pediatrics, communicable diseases and neurology.

To read the entire article click here.


Dr. Brian Callaghan Receives Endowed Career Development Professorship

Dr. Brian Callaghan, a U-M neurology professor and ALS researcher, has been named the first Fovette E. Dush Early Career Professor by the University of Michigan Medical School’s Department of neurology.

Callaghan received the five-year appointment at a reception Dec. 7 hosted by Dr. James O. Woolliscroft, dean of the U-M medical school.

The professorship, intended to support the study of neurodegenerative muscular diseases, was established with funds donated by the late Ms. Dush, a Battle Creek native known for her investing acumen and lifelong generosity.

“This professorship will help me jump-start my career here, focusing on neuropathy,” said Callaghan. “We’ll be both looking for new treatments and for how we can do the best for patients with what we already have.”

Callaghan is associate director of the U-M ALS clinic, which treats patients suffering from amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease. His ongoing ALS projects include an analysis of DNA changes that may explain why patients develop ALS and a stem cell project studying neurons and other cells derived from ALS patients. Other current research interests are focused on determining the optimal evaluation of peripheral neuropathy.

“Brian is one of our most promising researcher-physicians,” said Dr. Eva Feldman, director of the ALS clinic, director of the Taubman Institute and the Russell N. DeJong professor of neurology at U-M. “We are delighted that his work has been recognized and that he’s received the great honor of being selected as the first recipient of this professorship.”

Ms. Dush graduated from Battle Creek Central High School in 1937; she completed secretarial studies at Argubright Business College and then began a lifelong career as an administrative assistant at the Battle Creek Federal Center. According to family members, she was an active artist, gardener and volunteer as well as a stylish woman who drove only Cadillacs yet lived frugally in a modest family farmhouse until her early 80s, when she moved to assisted living.

Known as a careful investor who read every prospectus from cover to cover, Ms. Dush consulted U-M doctors about health problems in her older years and – impressed with what she heard and saw in Ann Arbor – made plans for a substantial bequest to the medical school. Ms. Dush died in 2010 shortly after her 90th birthday.


Eva Feldman to Lead American Neurological Association

Eva Feldman, M.D., Ph.D., became president of the American Neurological Association on Sept. 27 at the organization's 136th annual conference in San Diego, Calif.

Feldman, director of the A. Alfred Taubman Medical Research Institute and a professor of neurology at the University of Michigan, will serve a two-year term as head of the 1,800-member ANA, which was established in 1874 by a group of physicians aiming to promote training and research in the field of neurology.

 "It's a great honor to lead a distinguished group of neurologists who share my mission of furthering the research and education that will enable us to find ground-breaking therapies and cures for diseases of the nervous system," says Feldman, whose faculty appointment at U-M is named for the late Russell N. DeJong, the longtime head of the U-M medical school's neurology department who also served as ANA president in 1965.

Feldman previously has served as a vice president for the ANA, and she is recent past president of the Peripheral Nerve Society. At U-M, she has an active clinical practice, serves as the research director of the ALS Clinic, and directs the Program for Neurology Research and Discovery, a team of 30 scientists.

Feldman has been listed among the Best Doctors in America for 10 consecutive years.

In her own work, Feldman focuses on amyotrophic lateral sclerosis (ALS – also known as Lou Gehrig's disease) and the neurological complications of diabetes. She is a leader in applying stem cell research to human disease; most notably she is the Principal Investigator of the first clinical trial of intraspinal transplantation of stem cells in patients with ALS. This Phase 1 trial is currently under way at Emory University in Atlanta, GA. Feldman's laboratory has begun the work of adapting this therapeutic approach for patients with Alzheimer's disease.

As director of the Taubman Institute, Feldman spearheads the program which provides unrestricted funding to Taubman Scholars -- leading researchers seeking cures for conditions and diseases ranging from diabetes to cancer to obesity. The Institute also supervises the Consortium for Stem Cell Therapies and several other initiatives.


Dr. Eva Feldman of the University of Michigan Begins Work On a Stem Cell Treatment for Alzheimer’s Disease

Alzheimer’s Disease is a devastating neurodegenerative disease characterized by dementia and memory loss. It afflicts more than 5 million people in America alone, exacting a terrible toll not only on patients and their families, but on the health-care system as a whole.

The University of Michigan Program for Neurology Research & Discovery, under the direction of Eva Feldman, M.D., Ph.D., has proposed a stem cell approach to Alzheimer’s Disease, which may for the first time bring relief to those suffering from the terrible affliction. It is based on a stem cell therapy that Dr. Feldman pioneered for the treatment of ALS (also known as Lou Gehrig’s Disease) and that is undergoing human clinical trials at Emory University in Atlanta.

“There are similarities between ALS and Alzheimer’s Disease that make us believe that our stem cell therapy should prove effective for both,” says Dr. Feldman. “Both diseases affect the same kind of neuron, though in different parts of the body.

“If the treatment works for ALS, we think it will also nurture and protect neurons under attack in Alzheimer’s Disease.”

The cells under siege in both diseases are cholinergic neurons. In the case of ALS, they are located in the spinal cord of patients, impairing the connections they make with muscles throughout the body.

Dr. Feldman has shown that injecting a type of stem cell called a neuronal precursor cell into animal models of ALS has decreased the progression of the disease. Neuronal precursor cells can be grown in tissue culture. They continue to divide and, under the appropriate conditions, mature into specific types of neurons.

Dr. Feldman has demonstrated that these cells, when injected into animals with ALS, are able to protect cholinergic motor neurons that otherwise would have been lost to the disease. That is the approach being tested in the human clinical trials at Emory.

In Alzheimer’s Disease, the cholinergic neurons are situated in a portion of the brain known as the basal forebrain. These neurons create a network that connects areas of the frontal lobe, which regulate personality and behavior, with areas of the temporal lobe, which regulate learning and memory. Loss of these neurons is thought to be a major cause of Alzheimer’s Disease.

Dr. Feldman’s work on Alzheimer’s Disease will begin with an animal model of disease, and if successful, progress to human clinical trials. Neuronal precursor cells will be directly injected into the cholinergic centers of the brain in animals with the disease.

Her team of researchers will then assess the animals’ behavior and the rate of disease progression and correlate these measures with the survival and connectivity of the injected stem cells.

Dr. Feldman believes that the neuronal precursor cells will protect the cholinergic neurons, allowing them to maintain important connections within the brain and slowing the disease progression.

The neuronal precursor cells that will be used in these studies have already been approved by the FDA for human use. Therefore, positive results in the human clinical trials for ALS will have a direct bearing on their use to treat Alzheimer’s Disease.


D Business Profiles Dr. Eva Feldman

Leading Metro Detroit business magazine explores the groundbreaking science of Dr. Feldman and her laboratory team.

To read the entire article click here.

New Partnership to Speed Pace of Cures

The Program for Neurology Research & Discovery is now an affiliated program of the Michigan Institute for Clinical and Health Research (MICHR).

As part of the agreement, the Program will have access to MICHR's clinical research support, including the Michigan Clinical Research Unit, which supports human tests of new treatments and medications, as well as its biorepository, educational programs and more.

“Adding the Program for Neurology Research & Discovery to MICHR's affiliations and alliances is beneficial to each of the constituencies we serve, and I am very pleased that we are bringing together our collective expertise and resources," said Ken Pienta, M.D. and MICHR Director.

“As we continue to look for ways to enable and enhance clinical and health research, partnering with excellent programs like Eva Feldman's Program for Neurology Research & Discovery help accelerate the pace of scientific discovery at U-M."

Dr. Feldman, M.D., Ph.D, the Director of the Program for Neurology Research & Discovery, is equally excited about the new collaboration.

“We are so pleased to be working with MICHR, whose mission and ideals we share,” she said. “It will help provide the resources we need to quicken the pace of turning our research into new treatments for our patients.”

MICHR seeks to enable and enhance the positive impact of clinical and translational research at the University of Michigan, and to make U-M a world leader in translating scientific discoveries into real health gains.


First U.S. stem cells transplanted into spinal cord

from CNN – For the first time in the United States, stem cells have been directly injected into the spinal cord of a patient, researchers announced Thursday, January 21.

Doctors injected stem cells from 8-week-old fetal tissue into the spine of a man in his early 60s who has advanced ALS, or amyotrophic lateral sclerosis. It was part of a clinical trial designed to determine whether it is safe to inject stem cells into the spinal cord and whether the cells themselves are safe.


Eva Feldman Elected President of ANA

Eva Feldman, M.D., Ph.D., director of the Program for Neurology Research & Discover, has been named president-elect of the American Neurological Association, a professional society of academic neurologists and neuroscientists.

The announcement was made at the association's annual meeting Oct. 11-14 in Baltimore. She will become president in two years.

The association educates physicians in the neurosciences and works to better understand and treat nervous system diseases.

At U-M Medical School, Feldman also directs the A. Alfred Taubman Medical Research Institute, the ALS Clinic and the Juvenile Diabetes Research Foundation Center.


The first stem cell trial for ALS treatment wins FDA approval

New therapy that U-M neurologist helped develop will undergo Phase I trial at Emory University

U.S. Food and Drug Administration gave the green light Friday for a clinical trial of a new stem cell treatment for amyotrophic lateral sclerosis (ALS). University Michigan neurologist, Eva Feldman, M.D., Ph.D., will be the overall principal investigator for the first human clinical trial of a stem cell treatment for ALS, a fatal neurodegenerative disease.

The FDA approved an Investigational New Drug application from Neuralstem, Inc., a Rockville, Md.-based biotech company, to test the safety of a treatment in which patients will receive injections of the company’s patented neural stem cells at multiple sites along the spinal cord.

Director of the U-M ALS Clinic and the Director of the Program for Neurology Research & Discovery, Feldman worked with a team of neurologists and with Neuralstem Inc. to develop the protocol for delivering the stem cells into the spinal cord of patients.

The Phase 1 trial to determine the safety of the treatment is expected to take place exclusively at Emory University in Atlanta, Ga., subject to approval by its Internal Review Board.

“We are very excited about this clinical trial,” said Feldman, the DeJong Professor of Neurology at the U-M Medical School. “This is a major stride forward in what still could be a long road to a new and improved treatment for ALS.

“ALS is a terrible disease that ultimately kills by paralysis. In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don’t want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS,” Feldman said.

ALS, also known as Lou Gehrig’s disease, affects about 30,000 Americans. It progressively destroys the neurons that control voluntary muscles, leaving affected people unable to move or speak. There are no known treatments for the disease that slow its progression.

The trial will ultimately consist of 18 ALS patients with varying degrees of the disease. The FDA has approved the first stage of the trial, which consists of 12 patients who will receive five-to-ten stem cell injections in the lumbar area of the spinal cord.  The patients will be examined at regular intervals post-surgery, with final review of the data to come about 24 months later.

Jonathan Glass, M.D., director of the Emory Neuromuscular Laboratory, is expected to be the site principal investigator for the trial.

Individuals interested in further information on the trial should contact Emory Health Connection, 404-778-7777, or 1-800 75EMORY, or go to www.neurology.emory.edu/als 

Institutional review boards at U-M and Emory University must first approve the protocol.
If Phase I results are favorable, the treatment will need to prove effective in Phase II and III trials and win final FDA approval before it can be available for public use.

Funding: Neuralstem, Inc. plans to conduct and fund the Phase I trial of its patented technology.
Patents/conflict disclosures: Dr. Feldman has no financial interest in or financial arrangement with Neuralstem.

Other coverage:


Big Ten Network video

Stem cell research has the potential of transforming what we know about human biology and how we treat a host of human diseases.

The University of Michigan’s Program for Neurology Research & Discovery is at the forefront of this new technology.

You can see the progress this team of scientists is making in stem cell research in a new video, produced by Michigan Television as part of its “Out of the Blue” series.

This revealing look at stem cell research will be shown two more times this week on the Big Ten Network, a cable channel that broadcasts features and sports from the universities that comprise the conference.

The show will air at:

Thursday, August 6 at 9:30 p.m.
Sunday, August 9 at 10 a.m.

You can also watch the video here.

It takes viewers inside the laboratory to examine the research the Program team is conducting to understand the biology of stem cells and put them to use in developing new therapies for disorders, such as ALS, diabetes and Alzheimer’s disease.

It also talks to a patient with ALS, whose courage and love for family lend a sense of urgency to the work being doing in the laboratory.

As this video so dramatically demonstrates, researchers are on the verge of a new tomorrow in medical science.


U-M launches new embryonic stem cell research consortium

High magnification image of human embryonic stem cells differentiated into neurons (red cells) by treating cells with a growth factor. These could be used to study the development of the nervous system, birth defects or to replace cells lost to injury, aging or diseases such as Parkinson’s. Courtesy of Sue O'Shea, PhD

ANN ARBOR, Mich. --- The University of Michigan today announced the formation of a consortium to create new embryonic stem cell lines that will aid the search for disease treatments and cures.

The A. Alfred Taubman Medical Research Institute Consortium for Stem Cell Therapies is the first major embryonic stem cell research program launched in Michigan since the Nov. 4 passage of a state constitutional amendment allowing scientists to create new stem cell lines using surplus embryos from fertility clinics.

The launch of this center, combined with the recent state law change and President Obama's executive order loosening restrictions on federal funding for embryonic stem cell research, is expected to transform embryonic stem cell research at the University of Michigan.

 "The Consortium for Stem Cell Therapies will catalyze efforts by world-class scientists at the University of Michigan who are devoting their full talents to the search for new treatments and cures,” said U-M President Mary Sue Coleman. “At the University of Michigan, we believe stem cell research offers one of our best hopes for finding new treatments and cures for a wide variety of diseases.”

The center will be based at the MedicalSchool, and the work is expected to begin this spring. Funding commitments of nearly $2 million have been secured to start the program, and additional fund-raising efforts are underway.

The consortium will develop new embryonic stem cell lines for researchers and clinicians. In addition, collaborations are being negotiated between the U-M and its University Research Corridor partners, Michigan State University and Wayne State University. Collaborations are also in the works with Oakland University, U-M Dearborn and Case Western Reserve University in Ohio, said center co-director Sue O’Shea, professor of cell and developmental biology.

“We’re talking about an initiative that extends beyond the University of Michigan,” O’Shea said. “This center will provide critical resources to other institutions while building partnerships that could grow to become regional in scope.”

In addition to deriving new embryonic stem cell lines, researchers will use recently developed techniques to convert adult skin cells into induced pluripotent stem cells, known as iPS cells. These reprogrammed cells display the most scientifically valuable properties of embryonic stem cells, while enabling researchers to bypass embryos altogether.

A top priority of the consortium is to derive new lines of human embryonic stem cells and iPS cells that carry the genes responsible for inherited diseases. These cell lines will be used to probe the causes and progression of disease, and to test potential therapies. Likely early disease targets include neurological conditions such as amyotrophic lateral sclerosis (Lou Gehrig’s disease), Huntington’s and Alzheimer’s, as well as diabetes.

“There are very few university programs in the United States that are deriving new embryonic stem cell lines, and even fewer focusing on disease-affected lines,” said consortium co-director Gary Smith,associate professor of obstetrics and gynecology who directed the U-M fertility clinic for the past decade.

“Our special niche will be creating, studying and understanding normal and abnormal development of disease-affected lines,” Smith said. “And these lines will be invaluable in the clinic, as well as the laboratory. We’ll use the latest derivation techniques to ensure that these lines qualify to be used, some day, on patients participating in clinical trials.”

Smith said the consortium will leverage one U-M’s core strengths: interdisciplinary collaborative research. The new center will build on existing partnerships between scientists and clinicians at the MedicalSchool, the Life Sciences Institute, the College of Engineering, the School of Dentistry, the School of Public Health, the College of Literature, Science and the Arts, and the Gerald R. Ford School of Public Policy.

“The work that we’ve done with embryonic stem cell lines to date is important, but it’s really the tip of the iceberg compared to what the future holds,” he said.

Embryonic stem cells are the body’s master cells; they replicate endlessly and form the more than 200 cell types of the human body. Scientists hope these remarkably versatile cells – and the iPS cells that mimic them -- can someday replace faulty cells or diseased tissues in failing organs. This fledgling field is known as regenerative medicine, and the new consortium positions the University of Michigan to play a leadership role, said Doug Engel, chair of the cell and developmental biology department and chair of the new consortium’s scientific advisory board.

“In addition to enabling important new science and clinical work, this consortium puts us in an incredibly strong position to pursue any new federal funds that become available for embryonic stem cell research, and to recruit the brightest young scientists in the field, Engel said. “This initiative will help move the University of Michigan to the forefront of every aspect of stem cell biology.”

The U-M consortium will be among the first groups in the country to derive new embryonic stem cell lines that are linked to a data base containing genetic and medical-history information about the embryo donors and their families. The data base will enable researchers to examine how the disease genes in a given cell line have manifested themselves in previous generations.

“In my Program for Neurology for Research & Discovery, our scientists study a spectrum of diseases --- ALS, Alzheimer’s, diabetic complications, childhood muscle diseases, to name a few,” said Dr. Eva Feldman, director of the U-M’s A. Alfred Taubman Medical Research Institute.

“We will now be able to obtain stem cell lines to better understand the cause and develop new therapies for these diseases," Feldman said. “Can you imagine what a powerful tool stem cells will be?”

Human embryonic stem cell work has been underway for several years at the University of Michigan. O’Shea currently directs the MichiganCenter for Human Embryonic Stem Cell Research, which stores and studies cell lines approved by the Bush administration, and trains researchers to use them.

The new consortium will supersede that center, which formed in 2002. While taking on the additional tasks of deriving embryonic and iPS stem cell lines, the new consortium will retain many of the core services provided by its predecessor. The consortium will be a cell-line repository, and staff members will train other scientists to work with the lines.

At U-M, human embryonic stem cell work is also underway at the Center for Stem Cell Biology, launched in 2005 and located at the Life Sciences Institute. Researchers at the LSI-based center work with both adult and embryonic stem cells.

Sean Morrison directs the Center for Stem Cell Biology and will serve on the new consortium’s scientific advisory board. He said the two entities are complementary; both contribute to the larger goal of bolstering U-M’s stem-cell research program.

“We’ve been laying the groundwork for this consortium for years, and everything is finally coming together exactly the way we had hoped,” Morrison said.

 “By improving the facilities and resources available for embryonic stem cell research at the University of Michigan, this new consortium will enhance our ability to recruit new faculty to the Center for Stem Cell Biology. So the new consortium is one important element of a larger university plan.”

To create new embryonic stem cell lines, the A. Alfred Taubman Consortium for Embryonic Stem Cell Therapies will use surplus embryos remaining following infertility treatment. Several hundred early stage embryos – which would otherwise have been discarded – have been donated and consented for use in research.

“Embryonic stem cell research is the most important advancement in medical science since the advent of antibiotics a half century ago,” said A. Alfred Taubman, philanthropist, retail pioneer and U-M alumnus. “The creation of this consortium positions the state of Michigan at the forefront of this promising scientific and medical frontier. In doing so, we will make this a healthier world for generations to come.”

So far, funding for the project has been pledged by the A. Alfred Taubman Medical Research Institute, Executive Vice President for Medical Affairs Dr. Robert Kelch, Medical School Dean Dr. James Woolliscroft, the Life Sciences Institute, the College of Engineering, the Department of Cell and Developmental Biology, the Comprehensive Cancer Center, the Department of Pediatrics and Communicable Diseases, the Cardiovascular Center, the Department of Neurology, the Department of Pathology, and the Clinical and Translational Science Award consortium.

“Important collaborations like this consortium are critical to meeting medicine’s greatest challenges,” Woolliscroft said. “By partnering with our colleagues in the region, we can accelerate the translation of scientific discoveries into societal benefit.”
 
The consortium will fully conform to the provisions of the state constitutional amendment approved by Michigan in 2008. Additionally, the U-M will strictly adhere to the guidelines for the conduct of human embryonic stem cell research issued by the International Society for Stem Cell Research.
                                             
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