Navigation Links
FDA approves Phase II of stem cell trial for ALS led by U-M's Dr. Eva Feldman
Date:4/17/2013

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.


'/>"/>

Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... Feb. 4, 2016 The field of ... of the most popular hubs of the biotechnology ... other huge studies of human microbiota, have garnered ... years, the microbiome space has literally exploded in ... This report focuses on biomedical aspects of ...
(Date:2/3/2016)... Feb. 3, 2016 Vigilant Solutions announces today ... in Missouri solved two recent ... (LPR) data from Vigilant Solutions. Brian Wenberg ... which the victim was walking out of a convenience store and witnessed an ... to his vehicle, striking his vehicle and leaving the ...
(Date:2/2/2016)... , Feb. 2, 2016 This BCC ... bioinformatic market by reviewing the recent advances in ... that drive the field forward. Includes forecast through ... Identify the challenges and opportunities that exist in ... software solution developers, as well as IT and ...
Breaking Biology News(10 mins):
(Date:2/11/2016)... 11, 2016   BioInformant announces the February ... Research Products, Opportunities, Tools, and Technologies – Market Size, ... The first and ... cell industry, BioInformant has more than a decade of ... market, by stem cell type. This powerful 175 page ...
(Date:2/11/2016)... ... February 11, 2016 , ... ... a new agreement with Bankok,Thailand-based Global Stem Cells Network (GSCN) to distribute exosome ... Latin American countries, including Mexico, Costa Rica, Dominican Republic, Colombia, Argentina, Nicaragua, Panama, ...
(Date:2/10/2016)... MONTREAL , Febr. 10, 2016 /PRNewswire/ - BioAmber Inc. ... is pleased to announce that Mitsui & Co. Ltd., ... bio-based succinic acid plant, is investing an additional CDN$25 ... equity, increasing its stake from 30% to 40%.  Mitsui ... of bio-succinic acid produced in Sarnia ...
(Date:2/10/2016)... Feb. 10, 2016  The Maryland House of Delegates ... announced that University of Maryland School of Medicine Dean ... University of Maryland Medical System President and CEO ... Medallion," the highest honor given to the public by ... Dean Reece and Mr. Chrencik for their ...
Breaking Biology Technology: