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

Approval clears way for expanded U-M clinical trial role.

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.

Read more

 


Help Us Make A Difference. Make A Donation That Could Save Lives.

Make A Gift

Connect/
Share/
follow/

Follow Us / Friend Us

Discovery-driven research that matters

phallodin

Taubman Scholar Dr. Charles Burant tests promising diabetes drug

TAK-875, a new treatment for type 2 diabetes, improves blood sugar control and is equally effective as glimepiride, but has a significantly lower risk of creating a dangerous drop in blood sugar, called hypoglycemia, according to a new study.

Read more

Taubman Institute leaders make the case for more doctor-scientist funding

 

The prestigious "Academic Medicine" journal has just published a new article authored by Taubman Institute senior management and Detroit-area attorney Scott Roberts.

The article explores the problematic gap between bench research and clinical application of new treatments or cures. 

Read more


Help Us Make A Difference. Make A Gift.

Leaders from the realms of business, academia and the community help to refine the Taubman Institute's vision, to monitor progress and to provide support, advice and counsel.

Meet the Leadership Advisory Board

Meet the Scientific Advisory Board

About Taubman Institute Video

In this video feature, Taubman Scholars explain why funding for high-risk research is so important to their work and to the discovery of promising cures and treatments.  

 

Stem cell surgery targets ALS Video

Patients glean hope from trial’s progress but wish it were faster

 

video-emerging-scholars-programDonors pitch in to keep brilliant science minds at U-M Video

Emerging Scholars program connects promising M.D.-researchers with philanthropists