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:7/2/2015)... June 25, 2015 Research ... the "Next Generation Biometrics Market by Application, Technology, ... report to their offering. The next generation ... 2020, at a CAGR of 17.9% between 2015 and ... application for the market. Safran SA ( ...
(Date:6/30/2015)... June 30, 2015 To bolster its efforts and ... Corp. announced today the addition of two new team members. ... board advisor and David Raviv will act as ... HYPR Corp.,s commitment to providing the most secure solutions for ... co-founded Layer 7 Technologies, a provider of security and ...
(Date:6/29/2015)... June 24, 2015 Research ... the "Latin America Biomedical Sensors Market - Growth, ... The Latin America Biomedical Sensors market is ... of 2.04% over the period 2014-2020 The ... to the genetic formulation of each individual. These sensors ...
Breaking Biology News(10 mins):Next Generation Biometrics Market 2015 - Global Forecast to 2020 with Safran, NEC, 3M Cogent, Fujitsu & Suprema Dominating the $24 Billion Market 2Next Generation Biometrics Market 2015 - Global Forecast to 2020 with Safran, NEC, 3M Cogent, Fujitsu & Suprema Dominating the $24 Billion Market 3HYPR Corp. Expands Biometric Authentication Team with Enterprise All Stars 2HYPR Corp. Expands Biometric Authentication Team with Enterprise All Stars 3Latin America Biomedical Sensors Market Report 2015-2020 2
... an ongoing effort to mirror the ability of biological ... scientists from the McGowan Institute for Regenerative Medicine have ... both biological and chemical toxins. They described the findings ... biological principles to create materials that can do many ...
... University of Florida engineering researchers have found they can ... say opens the door to a wave of new technologies ... about the research appears in this week,s advance online edition ... Ben Koopman and Brij Moudgil say they used lasers not ...
... from the Robertson Foundation to create a state-of-the-art Translational ... cell therapy research and treatment programs for children and ... suffered at birth. In making the announcement, Victor J. ... Chief Executive Officer for Duke University Health System, said ...
Cached Biology News:Multifunctional polymer neutralizes both biological and chemical weapons 2Engineers: Weak laser can ignite nanoparticles, with exciting possibilities 2Engineers: Weak laser can ignite nanoparticles, with exciting possibilities 3Robertson Foundation donates $10.2 million for Duke Cell Therapy Center 2Robertson Foundation donates $10.2 million for Duke Cell Therapy Center 3
(Date:7/28/2015)... ... , ... VetStem Biopharma will be offering weekly private guided tours of our ... , The tour and course will be given every Wednesday at 6pm to local ... Staff members are welcome to attend with their veterinarian as well. Participants will be ...
(Date:7/28/2015)... , July 28, 2015 BioStructures, LLC, ... has hit a milestone of 4,000 implantations of ... 510(k) cleared in early 2014 as a bone ... spine fusion procedures.  This is a distinguished status ... than 6% of new synthetic products have received ...
(Date:7/28/2015)... , July 28, 2015  Faced with ... that are palliative rather than symptomatic, the global ... few existing therapies capable of curing or significantly ... are starting to look towards regenerative medicine as ... a new paradigm in human health with the ...
(Date:7/27/2015)... ... ... Production of high tenacity filament yarn of viscose rayon (excluding sewing thread) demonstrated ... surpassed the EUR 106 million mark (in value terms) in 2013, while it stood ... while Italy is a key consumer. , The high tenacity filament yarn of ...
Breaking Biology Technology:VetStem Biopharma weekly veterinary continuing education classes and GMP manufacturing facility tour 2Revolutionary Bone Graft Exceeds Expectations 2Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan 2Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan 3Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan 4Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan 5High Tenacity Filament Yarn of Viscose Rayon Consumption to Grow Swiftly in the EU, Forecasts BAC Reports in New Study Available at MarketPublishers.com 2
... your hard disk starts screeching and you haven,t backed up your ... the past thanks to research into a new kind of computer ... at IBM Research,s Zurich lab have made new advances in researching ... the standard method of storing information on home computers. ...
... Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ) announced today ... hepatitis C programs at the Canaccord Adams Hepatitis C Conference ... InterContinental The Barclay New York Hotel in New York City.The ... under "Calendar of Events" in the Idenix Investor Center at ...
... to Find Partner to Co-Develop Company,s Chinese Patented ... April 3 Sinobiopharma, ... is pleased to announce that it ... international marketing organization headquartered in New Jersey that ...
Cached Biology Technology:Beating the back-up blues 2Sinobiopharma Signs Export Agreement With U.S. Pharmaceutical Supplier 2
The FailSafe™ PROBES Real-Time PCR System enables rapid, precise optimization of PCR experiments in which the product is detected using fluorescent target-specific labeled probes....
Anti-hamster Ig HRP detection kit...
...
...
Biology Products: