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:12/3/2014)... GLENDALE, Ariz. , Dec. 2, 2014 ... biometric hand readers, Inception Technologies is pleased to announce ... it easier for customers to collect the workforce data ... the problems that have been left by existing readers. ... to user interface, connectivity and modern technology. Older models ...
(Date:11/21/2014)... , Nov. 20, 2014   Atmel® Corporation ... microcontroller (MCU) and touch technology solutions, today launched the ... with the widest V cc range from ... accuracy and faster I 2 C bus communication speeds, ... EEPROM memory making them ideal for consumer, industrial, computer, ...
(Date:11/15/2014)... , Nov. 13, 2014  While we may still be ... McCoy used in "Star Trek" to gain instant access to ... to work with smartphones and tablets for monitoring and measuring ... healthcare world. This may seem a tad Orwellian to some, ... adopt some of these technological opportunities into their healthcare regime. ...
Breaking Biology News(10 mins):Inception Technologies to Release New Biometric Reader 2Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 2Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 3Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 4Americans May Be Ready for a Brave New World of Healthcare 2Americans May Be Ready for a Brave New World of Healthcare 3Americans May Be Ready for a Brave New World of Healthcare 4
... A team of Princeton University scientists has discovered that ... like adaptive machines, possessing the ability to control their ... evidence of a hidden mechanism guiding the way biological ... a new perspective on evolution, the scientists said. ...
... team are researching nano-scale cantilevers that have the potential to ... the air. Put them into a small handheld device and ... in industry, in health care and even at home. ... work has been something we,ve only seen so far in ...
... children love sending and receiving text messages through their cell ... But now a new study from the University of ... used to reduce children,s chances of becoming overweight or obese ... own behaviors now. Recent studies show that approximately ...
Cached Biology News:Evolution's new wrinkle 2Evolution's new wrinkle 3Evolution's new wrinkle 4Clemson researchers advance nano-scale electromechanical sensors 2UNC study: Text messaging may help children fight off obesity 2UNC study: Text messaging may help children fight off obesity 3
(Date:12/19/2014)... (PRWEB) December 18, 2014 With only ... time special on Sartorius Biohit products . The ... mLINE pipettes, Picus Electronic Pipette Trade-in Program, and free ... and Safety officers around the world. They are ideal ... Other features include:, ,     Full volume range ...
(Date:12/19/2014)... 18, 2014   ISN has released its ... Indicators publication series. With data aggregated from ... in 2013 within its online contractor management platform, ISNetworld, ... performance indicator (KPI) statistics. The ... publication is available in two industry specific volumes: ...
(Date:12/17/2014)... 2014 Based on the revenues ... imaging market is dominated by four major players ... market. These players include GE Healthcare (U.K.), Siemens ... , Full Report Copy at http://www.marketsandmarkets.com/Market-Reports/surgical-imaging-market-210534462.html ... can be attributed to its strong product portfolio, ...
(Date:12/17/2014)... RIDGE, N.J. (PRWEB) December 17, 2014 ... (Euronext: IPN; ADR: IPSEY), today ... mg (referred to as Somatuline®) was approved by ... the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in ... locally advanced or metastatic disease to improve progression-free ...
Breaking Biology Technology:Major Pipette Distributor Pipette.com Announces Sartorius Year End Specials 2ISN Releases Third Edition of US Contractor Health & Safety Performance Indicators Publication Series 2ISN Releases Third Edition of US Contractor Health & Safety Performance Indicators Publication Series 3Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 2Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 3Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 4Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 2Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 3Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 4Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 5Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 6Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 7Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 8
... Beardsworth Consulting Group, Inc. announces the appointments of Alison ... W. Malone , M.D. as the company,s Medical Director, Vaccines. , ... Dr. Alison Martin ... clinical research experience.  She joins Beardsworth from the National Cancer Institute (NCI) ...
... New York University (NYU), and the University of Milan, ... GOALIE that can automatically reveal how biological processes are ... division, metabolism, and development must be carefully synchronized for ... time is a complex problem in the field of ...
... electron to exist in two places at once has been ... for the first time. The research findings - published in ... of Surrey, UCL (University College) London, Heriot-Watt University in Edinburgh, ... marks a significant step towards the making of an affordable ...
Cached Biology Technology:Alison Martin, MD and Robert W. Malone, MD Join Beardsworth 2Data mining algorithm explains complex temporal interactions among genes 2Data mining algorithm explains complex temporal interactions among genes 3Data mining algorithm explains complex temporal interactions among genes 4'Quantum computer' a stage closer with silicon breakthrough, reports Nature journal 2
... Product Rabbit polyclonal to JNK1 ... peptide mapping to an internal domain containing phosphorylated ... Human, Mouse and Rat. Not yet tested in ... consist of several subgroups, including the ERK, JNK, ...
... potent Rnase free Ribonuclease Inhibitor ... broad range of temperatures and ... not inhibit SP6, T7, or ... M-MLV reverse transcriptase or Taq ...
Dako Target Retrieval Solution, Citrate pH 6 (x 10) For more information, please visit Dako' web-site. EU regulatory status: CE US regulatory status: IVD...
... All the functionality of the micro1401 but ... and more available channels of waveform input ... option for programmable front-end gain. Can be ... waveform inputs and from 4 to 8 ...
Biology Products: