Navigation Links
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

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


Contact: Kara Gavin
University of Michigan Health System

Related biology news :

1. King Richard III search in new phase after discovery has potential to rewrite history
2. National Geographic unveils new phase of genographic project
3. F1000Research, the first Open Science publisher, launches following a successful beta testing phase
4. In beef production, cow-calf phase contributes most greenhouse gases
5. Study jointly led by UCSB researcher supports theory of extraterrestrial impact
6. Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock
7. Canadian Journal of Cardiology publishes new atrial fibrillation guidelines
8. New clinical trial explores novel noninvasive colon cancer screening test
9. Clinical trial launches to see whether vitamin D helps treat multiple sclerosis
10. Trial seeks improved lung-cancer screening by combining imaging and biomarkers
11. Trial launched into curry chemicals cancer-fighting properties
Post Your Comments:
(Date:11/17/2015)... , November 17, 2015 ... au 19 novembre  2015.  --> Paris ... --> DERMALOG, le leader de l,innovation biométrique, ... la fois passeports et empreintes sur la même surface ... les passeports et l,autre pour les empreintes digitales. Désormais, ...
(Date:11/12/2015)... BOSTON , Nov. 12, 2015  A golden ... for Duchenne muscular dystrophy (DMD) has provided a new ... Boston Children,s Hospital, the Broad Institute of MIT and ... Brazil . Cell, ... some dogs "escape" the disease,s effects. The Boston Children,s ...
(Date:11/10/2015)...  In this report, the biomarkers market ... type, application, disease indication, and geography. The ... consumables, services, software. The type segments included ... biomarkers, and validation biomarkers. The applications segments ... drug discovery and development, personalized medicine, disease ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... Nov. 24, 2015 Halozyme Therapeutics, Inc. (NASDAQ: HALO ... New York on Wednesday, December 2 at ... , president and CEO, will provide a corporate overview. ... at 1:00 p.m. ET/10:00 a.m. PT . ... will provide a corporate overview. --> th Annual ...
(Date:11/24/2015)... 24, 2015  Clintrax Global, Inc., a worldwide provider of clinical ... today announced that the company has set a new quarterly earnings ... on quarter growth posted for Q3 of 2014 to Q3 of ... Mexico , with the establishment of an ... --> United Kingdom and Mexico ...
(Date:11/24/2015)... , November 24, 2015 ... recent market research report released by Transparency Market Research, ... expand at a CAGR of 17.5% during the period ... Testing Market - Global Industry Analysis, Size, Volume, Share, ... global non-invasive prenatal testing market to reach a valuation ...
(Date:11/24/2015)... ... 2015 , ... InSphero AG, the leading supplier of easy-to-use solutions for production, ... to serve as Chief Operating Officer. , Having joined InSphero in November ... and was promoted to Head of InSphero Diagnostics in 2014. There she has ...
Breaking Biology Technology: