Tag Archives: ALS

FDA approves Phase II of stem cell trial for ALS led by U-M’s Dr. Eva Feldman

ANN ARBOR, Mich. — For nearly two years, University of Michigan neurologist Eva Feldman, M.D., Ph.D. has led the nation’s first clinical trial of stem cell injections in patients with the deadly degenerative disease known as amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease.

Now, a new approval from the U.S. Food and Drug Administration paves the way for U-M to become the second site in the trial, pending approval of the U-M Institutional Review Board. To date, the first phase of the trial has taken place at Emory University, with Feldman serving as principal investigator.

The FDA approval of a Phase II trial was announced today by Neuralstem, the company whose product the trial is testing. The Phase II trial will continue to evaluate the safety of the stem cell injections, delivered directly into patients’ spinal cords in escalating doses of up to 400,000 cells per injection, with a maximum of 40 injections. It will also assess any signs that the injections might be impacting patients’ ALS symptoms or progression.

Feldman serves as an unpaid consultant to the company, and has led the analysis of results from the Phase I trial. In data presented last year, spinal cord injections of up to 100,000 cells were delivered safely and tolerated well — with possible signs that in one subgroup of participants, ALS progression may have been interrupted.

“In Phase II, we’ll be injecting stem cells into the upper part of the spinal cord, and our goal is to continue to assess whether this approach is safe, and to look at whether this approach offers some benefit to our patients. We are very pleased at the potential to bring this trial to the University of Michigan, where the initial research behind this technology was done — as well as having it continue at Emory,” says Feldman, the Russell N. DeJong Professor of Neurology at the U-M Medical School, research director of U-M’s ALS Clinic, and director of U-M’s A. Alfred Taubman Medical Research Institute. The neurosurgeon for the trial is Parag Patil, M.D, Ph.D.

The approach uses injections of stem cells delivered during an operation performed by a neurosurgeon. The first phase of the trial involved 15 patients; specific plans for Phase II are still being made but information will be available at neuralstem.com.

If the U-M site team receives IRB approval to recruit local participants, more information will be available at uofmhealth.org. The study at U-M will be funded by the ALS Association, the National Institutes of Health and Neuralstem.

Neuralstem Announces First Patient Treated in ALS Stem Cell Trial

ROCKVILLE, Md., Jan. 21 /PRNewswire-FirstCall/ — Neuralstem, Inc. (NYSE Amex: CUR) announced that the first ALS patient was treated with its spinal cord stem cells yesterday at the Emory ALS Center at Emory University, in Atlanta, GA.  A total of up to 18 patients is planned to be treated in this first U.S. clinical trial to evaluate human neural stem cells for the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s disease).  ALS affects roughly 30,000 people in the U.S., with about 5,600 new diagnoses per year, according to the ALS Association.

“The treatment of the first patient with our spinal cord stem cells represents a significant milestone for the Company,” said Neuralstem President and CEO, Richard Garr.

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Stem cell trial for ALS treatment gets FDA OK

From ChicagoTribune.com

A University of Michigan neurologist is the principal investigator for the first human clinical trial of a stem cell treatment for amyotrophic lateral sclerosis.

Dr. Eva Feldman has worked with a team of neurologists to develop the protocol for injecting neural stem into patients’ spinal cords. The cells are patented by Neuralstem Inc., a Rockville, Md.-based biotech company.

The U.S. Food and Drug Administration has approved Neuralstem’s plan to test the safety of the treatment for the fatal, untreatable neurodegenerative disorder commonly called Lou Gehrig’s Disease.

The initial phase to determine the safety of the treatment is to take place at Emory University in Atlanta.

Researchers plan trial for Lou Gehrig’s disease therapy

By Brooke Adams, The Salt Lake Tribune

The mice at the top of a column of stacked plastic bins at Q Therapeutics are shivering so hard they seem to be jumping.

Their nonstop shivering and seizures are caused by a genetic defect that robs the mice of the crucial myelin sheath that surrounds nerve cells and helps them send signals. Because of the defect, the mice are soon paralyzed and die prematurely.

It is a related problem — loss of this myelin sheath — that in humans causes the progressive loss of function in multiple sclerosis and several other diseases that can cause paralysis in humans.

And that’s why what has happened to the mice is so promising: After being treated with an adult stem cell therapy developed at Q Therapeutics, they are no longer shivering.

The product, called Q-Cells, also may be applicable to such neurodegenerative diseases as Parkinson’s, Alzheimer’s and amyotrophic lateral sclerosis, or ALS — better known as Lou Gehrig’s disease.

Now, the National Institutes of Health have awarded a $5 million grant to Q Therapeutics, the University of Utah’s Cell Therapy Facility and Johns Hopkins University School of Medicine, which as a team has had success in animal models of ALS.

The funding will help support work needed to get permission from the Food and Drug Administration to start human clinical trials at Johns Hopkins. If efforts to raise additional funds are successful, those trials would begin next year.

“This type of therapy can bring about a major change in modern health care,” said Deborah Eppstein, CEO of Q Therapeutics. “It’s not just a little step. It’s a pole vault change, a going to the moon change.”

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