First U.S. stem cells transplanted into spinal cord

stem_cells_neuralstemFrom 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 trialdesigned 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-DirectorEva FeldmanM.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

Eva_FeldmanNew 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

bluelab-feldmanStem 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

human embryonic stem cells

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.

Proposal 2 Opens the Door to Cures

Audrey SimonOn November 4, Michigan voters approved a state constitution amendment lifting many of the restrictions on embryonic stem cell research. It was a major step forward for doctors and researchers. It allows Michigan to join the other 45 states that allow this exciting, new field of medical inquiry.

In the run-up to the election, the Taubman Institute joined many others at the University of Michigan in an effort to educate the public about stem cell research, so that voters could make an informed decision on this crucial issue. Full Article

February 2008 – Nature Magazine profiles career highlights of Eva Feldman, MD, Ph.D.

Nature magazine honors Dr. Feldman with profiling her career highlights and her new role as director of the A. Alfred Taubman Medical Research Institute. She wants to promote high-risk, high-reward research which is typically not funded in today’s competitive climate. Her research includes the pursuit of stem-cell-based ALS therapies. Her colleagues are excited to have a leader eager to take risks at a time when most academics put forth conservative proposals to secure funding from the National Institutes of Health.

Dr. Feldman to head Taubman Institute

Neurologist and research scientist Eva Feldman, M.D., Ph.D., has been selected to direct the A. Alfred Taubman Medical Research Institute at the University of Michigan Medical School. The Institute was established in September, through a $22 million gift from the retail pioneer whose name it bears. Read the full article here.

With $22 million gift from A. Alfred Taubman, U-M Health System launches A. Alfred Taubman Medical Research Institute

With his $22 million gift to create the A. Alfred Taubman Medical Research Institute and support research at the U-M Medical School, Mr. Taubman has solidified his position as one of the leading donors to the University of Michigan. Only Stephen Ross has given more in his lifetime.

Mr. Taubman’s cumulative giving to the University now stands at more than $60 million – more than $56 million of which has been given as part of the University’s $2.5 billion Michigan Difference campaign. Read the full article here.

Neuralstem to Collaborate with University of Michigan ALS Clinic

ROCKVILLE, Md., Aug. 30 /PRNewswire-FirstCall/ — Stem cell company, Neuralstem, Inc. (Amex: CURNews), today announced it has entered into a collaborative agreement with the ALS Clinic at University of Michigan Health System, directed by Eva Feldman, M.D., Ph.D., the De Jong Professor of Neurology at the U-M Medical School. The goal of the collaboration is to provide further proof-of-principle data to move Neuralstem’s spinal cord stem cells into patients with Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig’s disease. ALS is a motor neuron disease, which strikes people between the ages of 40 and 70. As many as 30,000 Americans have the disease at any given time. Read the full article here.