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. Al
'/>"/>

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

Page: 1 2

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:8/28/2015)... 2015 According to a new ... Assessment Type (Pen & Paper Based, Hosted, Biometrics), Service, ... Academic Research), Vertical and Region - Global Forecast to ... to grow from USD 2.4 Billion in 2015 to ... Growth Rate (CAGR) of 25.6% from 2015 to 2020. ...
(Date:8/26/2015)... 2015 The report "Multi-Factor Authentication (MFA) ... Application (Travel & Immigration, Government, Banking, Defense, Commercial Security, ... 2020", published by MarketsandMarkets, Multi-Factor Authentication Market is expected ... a CAGR of 17.7% between 2015 and 2020. ... igures spread through 169 P ages ...
(Date:8/25/2015)... BELLEVUE, Wash. , Aug. 25, 2015  Sarcos ... today it will unveil its "Guardian S" snake robot, ... National Tactical Officers Association Conference on August 30 in ... is the first-ever commercially available energetically autonomous snake robot, ... in-field trials and is protected by more than 50 ...
Breaking Biology News(10 mins):Cognitive Assessment and Training Market Worth 7.5 Billion USD by 2020 2Cognitive Assessment and Training Market Worth 7.5 Billion USD by 2020 3Cognitive Assessment and Training Market Worth 7.5 Billion USD by 2020 4Multi-Factor Authentication Market Worth 9.60 Billion USD by 2020 2Multi-Factor Authentication Market Worth 9.60 Billion USD by 2020 3Multi-Factor Authentication Market Worth 9.60 Billion USD by 2020 4Multi-Factor Authentication Market Worth 9.60 Billion USD by 2020 5Sarcos to Debut First-of-its-Kind Snake Robot 2Sarcos to Debut First-of-its-Kind Snake Robot 3
... WASHINGTON, DC, JULY 7, 2008 -- The Soil Science ... by Senator Sherrod Brown and his colleagues in the ... as an "essential" natural resource, placing soil on par ... Brown was joined by co-sponsoring Senators Kent Conrad (D-ND), ...
... of cancer continues to pose a major problem for ... of chemotherapy or become resistant to the medication. Scientists ... Braunschweig, the Hannover Medical School (MHH) and Leibniz-Universitt (LUH) ... which a natural substance - argyrin - destroys tumours. ...
... MADISON, WI, JULY 6, 2008 -- Swine production generates ... that may serve as fertilizer when applied to agricultural ... different than what a crop requires. Application of waste ... in application of excess phosphorus which increases the potential ...
Cached Biology News:Senate resolution shines spotlight on the importance of soils 2Argyrin: Natural substance raises hope for new cancer therapies 2
(Date:8/28/2015)... Research and Markets ( ... "Global & USA BioSimilar Market Analysis to 2021" ... US Biosimilar market will be initiated in September as ... will the global market react? Will biosimilars explode into ... save the US economy up to $250 billion within ...
(Date:8/28/2015)... , August 28, 2015 According ... (Media, Sera, Cryogenic Storage Systems, Thawing Equipment, Alarms), by ... Medicine, Clinical Trials), End User - Global Forecast to ... expected to reach USD 3,731.03 Million by 2020 from ... of 11.65% between 2015 and 2020. ...
(Date:8/28/2015)... ... August 28, 2015 , ... Proove Biosciences ... the International Spine Intervention Society’ s 23rd Annual Scientific Meeting (ASM). ... 2015. With a focus on evidence-based research and clinical application, the event gathered ...
(Date:8/28/2015)... ... August 28, 2015 , ... Pittcon is ... will present a session on chemical spectroscopic imaging at JASIS 2015 (Japan Analytical ... Asia’s largest analytical and scientific instruments show which will be held at International ...
Breaking Biology Technology:Global & USA BioSimilar Market Analysis Report 2015-2021 2Global & USA BioSimilar Market Analysis Report 2015-2021 3Biopreservation Market Worth 3,731.03 Million USD by 2020 2Biopreservation Market Worth 3,731.03 Million USD by 2020 3Biopreservation Market Worth 3,731.03 Million USD by 2020 4Biopreservation Market Worth 3,731.03 Million USD by 2020 5Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 2Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 3Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 4U.S. Symposium on Imaging Organized by Pittcon’s Program Chairman Chuck Gardner 2U.S. Symposium on Imaging Organized by Pittcon’s Program Chairman Chuck Gardner 3
... CHENGDU, China, Sept. 17 /PRNewswire-Asia-FirstCall/ -- Tianyin,Pharmaceutical, Co., Inc., ... of,modernized traditional Chinese medicine (,TCM,) based in Chengdu, China, ... discuss its fiscal,2009 fourth quarter and full year results ... Interested parties may access the ...
... ... liquid medications, pharmacists are prepared to help children successfully take antiviral medications to fight the ... children are more likely to take their medicine as prescribed. , ... Columbia, MD, (PRWEB) September 17, 2009 -- As new ...
... ... software industries, among others , ... Boston, Massachusetts (Vocus) -- Brown Rudnick, an international law firm, today announced ... the Firm,s Boston office. With over 35 years of combined experience, the team includes ...
Cached Biology Technology:Tianyin Pharmaceutical Co., Inc. to Host Fiscal 2009 Earnings Conference Call on Thursday, September 24, 2009 at 10:30 a.m. ET 2FLAVORx Helps Families Fight Pandemic H1N1 Influenza Virus By Making Antiviral Medicine Taste Better 2FLAVORx Helps Families Fight Pandemic H1N1 Influenza Virus By Making Antiviral Medicine Taste Better 3FLAVORx Helps Families Fight Pandemic H1N1 Influenza Virus By Making Antiviral Medicine Taste Better 4Veteran Intellectual Property Team Joins Brown Rudnick 2