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:10/16/2014)... Cancer constantly wages war on the human body. ... a stalemate. In pancreatic cancer, this stalemate—known as ... becoming aggressively malignant, a phenomena that is poorly ... in the laboratory of Salvatore Torquato, a Professor ... the conditions surrounding tumor dormancy and the switch ...
(Date:10/16/2014)... a new synthesis of recent research findings to inform ... the two states. , The Ecology and Management ... A Synthesis of the Relevant Biophysical Science and Implications ... by the U.S. Forest Service,s Pacific Northwest Research Station, ... for a synthesis of the large body of scientific ...
(Date:10/16/2014)... monocultures can be cultivated efficiently, they are anything ... caused by monoculture cultivation is becoming increasingly evident. ... crop form and are regarded as the sole ... – quite wrongfully, finds Bernhard Schmid, an ecology ... a novel form of agriculture and forestry. After ...
Breaking Biology News(10 mins):Modeling tumor dormancy 2New report synthesizes best available science on management of moist mixed-conifer forests 2Plant communities produce greater yield than monocultures 2Plant communities produce greater yield than monocultures 3
... say they are astonished at the spectacular recovery of certain ... a devastating coral bleaching event in 2006. That year ... the Keppel Islands, in the southern part of the GBR. ... species of seaweed an event that can spell the ...
... study conducted in the Midwestern United States examined the ... uncultivated soils, vastly advancing the knowledge of water,s effects ... that is related to the physical-chemical state of the ... determine soil quality. During the wet season in the ...
... AUSTIN, TexasAdam Heller, an acclaimed chemical engineering research professor ... Austin, has been elected a fellow into the American ... Peace Prize laureate Nelson Mandela, actor James Earl Jones, ... Bono. "Dr. Heller is an outstanding scientist who ...
Cached Biology News:Reef boom beats doom 2Impact of floods on soils 2University of Texas at Austin engineer elected to American Academy of Arts and Sciences 2University of Texas at Austin engineer elected to American Academy of Arts and Sciences 3
(Date:10/22/2014)... Research and Markets has ... Diagnostics Market (Product types, Application, Technology, End User ... Profiles, Demand, Insights, Analysis, Research, Report, Opportunities, Segmentation ... their offering. This new report ... users and Geography) Global Size, Industry Analysis, Trends, ...
(Date:10/22/2014)... (PRWEB) October 21, 2014 The ... the inorganic refrigerants market in Americas with analysis ... TOC of the Americas Inorganic Refrigerants Market report, ... provided. This also provides a glimpse of the ... is supported by various tables and figures. ...
(Date:10/22/2014)... 2014 Shimadzu Scientific Instruments introduces its ... for the pain management and clinical markets. The software ... review by allowing users to highlight and review results ... QuantAnalytics allows analysts to filter results by group or ... by eliminating the need to sift through analytes of ...
(Date:10/22/2014)... WriteResult, LLC – a premier ... working with a team of researchers from Yale University’s ... Farming Collaborative to provide electronic questionnaire data collection through ... which started in May, aims to evaluate the impact ... exposure to and participation in urban agriculture to impact ...
Breaking Biology Technology:Global DNA Diagnostics Market (Product types, Application, Technology, End User and Geography) - Forecast to 2020 2Global DNA Diagnostics Market (Product types, Application, Technology, End User and Geography) - Forecast to 2020 3The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 2The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 3Shimadzu Releases QuantAnalytics Open Access LCMS Software Package for Clinical Applications 2myPROpad™ Topic of Panel Discussion at the Yale Food Systems Symposium 2myPROpad™ Topic of Panel Discussion at the Yale Food Systems Symposium 3
... INDIANAPOLIS, April 21 Eli Lilly and ... for the first quarter of,2008., Financial results ... pro forma,basis. Reported results were prepared in accordance ... sales and expenses recognized,by the company during the ...
... for Bacterial,Detection, The Finnish biotechnology company Mobidiag ... world record by being able to detect,50 dangerous ... is an important milestone in the battle against ... 21 Sepsis is a growing cause of ...
... for vaccinating against a variety of infectious diseases ... than needles has proved able to produce a ... new studies. , The results build on previous success ... influenza, reported by University of Michigan researchers in 2003. ...
Cached Biology Technology:Lilly Reports Solid First-Quarter Results 2Lilly Reports Solid First-Quarter Results 3Lilly Reports Solid First-Quarter Results 4Lilly Reports Solid First-Quarter Results 5Lilly Reports Solid First-Quarter Results 6Lilly Reports Solid First-Quarter Results 7Lilly Reports Solid First-Quarter Results 8Lilly Reports Solid First-Quarter Results 9Lilly Reports Solid First-Quarter Results 10Lilly Reports Solid First-Quarter Results 11Lilly Reports Solid First-Quarter Results 12Lilly Reports Solid First-Quarter Results 13Lilly Reports Solid First-Quarter Results 14Lilly Reports Solid First-Quarter Results 15Lilly Reports Solid First-Quarter Results 16Lilly Reports Solid First-Quarter Results 17/C O R R E C T I O N -- Mobidiag Ltd/ 2Nanoemulsion vaccines show increasing promise 2Nanoemulsion vaccines show increasing promise 3Nanoemulsion vaccines show increasing promise 4
Mouse polyclonal antibody raised against a partial recombinant MHC2TA. NCBI Entrez Gene ID = 4261...
... Sight DS-L2 imaging controller is a successor ... and allows users to comfortably observe, record ... controller features an 8.4 inch LCD (XGA) ... of Nikon cameras including the DS-Fi1 , ...
Mouse monoclonal antibody to ST8SIA2 - ST8 alpha-N-acetyl-neuraminide alpha-2,8-sialyltransferase 2...
... Parametric Analyzer and Sorter) large particle flow ... of flow cytometry to applications that were ... analysis and sorting. Our instruments are ... flow cytometers, but are designed to accommodate ...
Biology Products: