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:8/12/2015)... August 12, 2015 As the ... payment innovation and advanced biometrics technology is accelerating beyond ... consumers rely on using their credit cards, the digital ... future for payment services led by companies in the ... :  Google, Inc. (NASDAQ: GOOG ), Apple Inc. ...
(Date:8/12/2015)... , Aug. 12, 2015  Synaptics Inc. ... human interface solutions, today announced that four of ... Match-in-Sensor solution, have officially been named FIDO Certified™ ... part of the certification, Synaptics, Natural ID™ fingerprint ... Universal Authentication Framework (UAF) standard and are interoperable ...
(Date:8/10/2015)... and TELTOW, Germany , ... Instruments (SMI), a world leader in Eye Tracking ... completion of its OEM Eye Tracking Platform for integration ... Tracking Platform contains reference designs for seamless integration of ... systems, virtual reality HMDs and augmented reality smart glasses. ...
Breaking Biology News(10 mins):Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 2Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 3Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 4Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 5Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 6Synaptics Announces FIDO Certification of Natural ID Fingerprint Solutions 2Synaptics Announces FIDO Certification of Natural ID Fingerprint Solutions 3SMI Completes OEM Eye Tracking Platform to Cover All Consumer Displays 2SMI Completes OEM Eye Tracking Platform to Cover All Consumer Displays 3
... defeat is influenced by his or her stance on ... of the most recent presidential and congressional elections. ... candidates, statements on climate change translated into real votes," ... science at Stanford, who led two new studies ...
... Administration (FDA) has awarded the Georgia Institute of ... Saint Joseph,s Translational Research Institute (SJTRI) a two-year, ... medical devices focused on the special needs of ... Pediatric Device Consortium, which will provide assistance with ...
... October 2011, Singapore A new biotech company has ... (NUS), to provide research tools, targeting the international malaria ... founded by two NUS faculty members: Dr Martin Lear ... Tan from the NUS Department of Microbiology. The company ...
Cached Biology News:Stanford researchers examine impact of 'green politics' on recent national elections 2Stanford researchers examine impact of 'green politics' on recent national elections 3FDA grant launches Atlanta Pediatric Device Consortium 2FDA grant launches Atlanta Pediatric Device Consortium 3FDA grant launches Atlanta Pediatric Device Consortium 4Launch of BioLynx provides a boost for the international malaria research community 2
(Date:8/26/2015)... /PRNewswire/ - iCo Therapeutics ("iCo" or "the Company") (TSX-V: ... the quarter ended June 30, 2015. Amounts, unless ... presented under International Financial Reporting Standards ("IFRS"). ... our Oral Amp B program, rapidly advancing towards ... Andrew Rae , President & CEO of iCo ...
(Date:8/26/2015)... 2015  Platform therapeutic company Symic Biomedical, Inc. ... $1.5M Phase II SBIR grant from the National ... therapeutic agent to reduce arteriovenous fistula (AVF) failures, ... renal disease (ESRD) patients undergoing hemodialysis. The two-year ... and Digestive and Kidney Diseases (NIDDK), will allow ...
(Date:8/26/2015)... , August 26, 2015 After litigating ... Europlasma NV relating to P2i United States ... their dispute in the United States ... the part of either party. As a result of the ... of California dismissed the case without ...
(Date:8/25/2015)... 25, 2015   WuXi PharmaTech (Cayman) Inc. (NYSE: ... technology platform company serving the pharmaceutical, biotechnology, and medical ... Hong Kong Exchange Stock Code: 0950), a research-based biopharmaceutical ... with 20 years of operations in China ... signed an agreement whereby WuXi,s Laboratory Testing Division (LTD) ...
Breaking Biology Technology:iCo Therapeutics Announces Second Quarter 2015 Financial Results 2iCo Therapeutics Announces Second Quarter 2015 Financial Results 3Symic Biomedical Awarded $1.5MM NIH Phase II SBIR Grant to Develop its Proteoglycan Mimetic Therapeutics to Reduce Vascular Access Failures in ESRD 2Symic Biomedical Awarded $1.5MM NIH Phase II SBIR Grant to Develop its Proteoglycan Mimetic Therapeutics to Reduce Vascular Access Failures in ESRD 3P2i Settles United States Litigation 2WuXi PharmaTech to Be Exclusive Supplier of Laboratory Testing Services to Lee's Pharm 2WuXi PharmaTech to Be Exclusive Supplier of Laboratory Testing Services to Lee's Pharm 3
... Board: KDUS) announced today financial results for the first,quarter ended ... 2008 were $100,000, compared to,$100,000 for the same period in ... compared to net loss of $558,469 for the same period ... a decrease in general,and administrative expenses of $47,207 and the ...
... Pharmaceutical Services, Inc.,(JOM), a service coordinator that provides ... Ortho Biotech, L.P., was notified May 6,2008, that ... PROCRIT(R) (epoetin alfa) and REMICADE(R) (infliximab) was,stolen while ... in,Kentucky to a specialty distributor. This incident has ...
... MedImmune today announced,that researchers will present eight ... Annual Meeting of the American Thoracic Society, ... Canada. Presentations are designed to showcase,MedImmune,s biologics ... innovative solutions that may one,day help patients ...
Cached Biology Technology:Cadus Reports First Quarter 2008 Results 2Cadus Reports First Quarter 2008 Results 3Ortho Biotech, L.P. and Centocor, Inc. Alert Authorized Distributors and Prescribing Physicians About Stolen Product 2Ortho Biotech, L.P. and Centocor, Inc. Alert Authorized Distributors and Prescribing Physicians About Stolen Product 3Ortho Biotech, L.P. and Centocor, Inc. Alert Authorized Distributors and Prescribing Physicians About Stolen Product 4Depth of MedImmune's Respiratory Disease Research Program Highlighted at Annual Meeting of the American Thoracic Society 2
...
Mouse monoclonal [M2II-12] to MRP2 ( Abpromise for all tested applications). entrezGeneID: 1244 SwissProtID: Q92887...
Mouse monoclonal antibody to ANAPC2 - anaphase promoting complex subunit 2...
... MAX POWER 500V Programmable Power Supply ... which can handle virtually any application ... current blotting. It is unique in ... The MAX POWER Programmable Power Supply ...
Biology Products: