Navigation Links
PI presents safety results in Neuralstem ALS Stem Cell Trial
Date:4/12/2011

ROCKVILLE, Maryland, April 12, 2011 Neuralstem, Inc. (NYSE Amex: CUR) announced that Eva Feldman, M.D., Ph.D., Principal Investigator of the Phase I safety trial of Neuralstem's human spinal cord stem cells (HSSC's) in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), and unpaid Neuralstem consultant, presented interim safety data on the first nine patients. Dr. Feldman reported yesterday at the American Academy of Neurology (AAN American Academy of Neurology (AAN) Annual Meeting (http://www.aan.com/go/am11) that all nine ALS patients remain alive and that there were no unresolved serious adverse reactions related to surgery. Of the three ambulatory patients who were treated, all remain ambulatory with no serious adverse events secondary to surgery.

"We are delighted. This data demonstrates it is feasible to transplant stem cells directly into the spinal cord of patients with ALS using the procedure and device we developed for this trial, " commented Dr. Feldman who is also Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "This groundbreaking work has never been done before, and we are thrilled that it can be done safely."

In this group of nine male patients, ranging in age from 37-to-66 years, with ALS duration at the time of surgery ranging from 1-to-12 years, the first six were non-ambulatory with complete paralysis. Of these, four out of six experienced transient neuropathic pain in the spinal dermatomes near the injected area within 24 hours of the procedure, which resolved with no treatment. Three out of the six experienced adverse events secondary to immunosuppression, which were resolved via dose adjustment in two cases and discontinuance in the third. One patient experienced a pulmonary embolism 19 days post-surgery secondary to an iliac vein thrombosis, unlikely related to the cells. All adverse events were resolved. In the group of ambulatory patients, all three remain ambulatory and experienced no serious adverse events secondary to surgery.

"It has been 15-to-4 months since the first nine patients have received the cells," said Karl Johe, Ph.D., Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "There have been no adverse reactions possibly or probably or definitely related to the cells. This indicates that the trial is proceeding as smoothly as can be hoped for. It is designed for transplantation to progress up to the cervical region of spinal cord as safety is demonstrated in the lumbar region," Dr. Johe continued. "With SMB and FDA review of the safety data from the 12 patients due to be completed in the next month, we hope to begin transplanting ALS patients in the cervical region this summer."

"This is significant and, we believe, compelling safety data," said Richard Garr president and CEO of Neuralstem. "It represents the first safety results from the world's first ALS neural stem cell trial, as well as the first data from Neuralstem's ongoing clinical programs. We believe it also validates our proprietary Spinal Injection Platform for the safe intraspinal delivery of our cells. We remain deeply indebted to the patients and their families who are participating in the study."

About the Study

Safety results were presented on nine patients in an ongoing Phase I study to evaluate the safety of Neuralstem's spinal cord stem cells (HSSC's), as well as the transplantation technique, in the treatment of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease).

Of these nine patients, the first six (Cohort A) were all non-ambulatory with permanent paralysis. The first of these was treated on January 20, 2010. Successive surgeries have followed at the rate of one every one-to-two months. The first three patients (Cohort A1) were treated with five unilateral HSSC injections in L2-L4 lumbar segments, while the next three patients (Cohort A2) received 10 bilateral injections in the same region. The next three patients (Cohort B) were all ambulatory and received five unilateral injections in the L2-L4 region. Since then, two more ambulatory patients have been transplanted, each receiving 10 injections in the same spinal region. Their data was not included in the interim results.

This Phase I safety trial is designed to enroll up to 18 patients. If approved by the FDA and the trial's safety monitoring board (SMB), the trial will progress to cervical transplantation in the summer of 2011.


'/>"/>

Contact: Deanne Eagle
deanneeagle@gmail.com
917-837-5866
Neuralstem, Inc.
Source:Eurekalert

Related medicine news :

1. Alfred B. Knight, M.D., Scott & White Healthcare, presents at 8th Annual World Health Care Congress
2. Cancer surgery society presents top honor to Kimberly Duchossois
3. Euthymics presents phase II data for EB-1010 in major depression at ACNP annual meeting
4. John Theurer Cancer Center presents studies on promising therapies for aggressive blood cancers
5. Professor Zvi Ram presents phase III recurrent glioblastoma survival and quality of life data from the first pivotal study of the NovoTTF-100A at 15th Annual Society for Neuro-Oncology Scientific Meeting
6. AAPS presents awards to exemplary researchers
7. Governor presents UH researcher with grant for cardiac device
8. Onconova Therapeutics presents new data demonstrating radioprotection by Ex-RAD at RRS annual meeting
9. APA presents latest research on same-sex marriage at annual convention in San Diego
10. AOSSM presents prestigious research awards at annual meeting
11. Pfizer Hemophilia presents new data at the World Federation of Hemophilia 2010 Congress
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Talented ... the lowdown on sciatica in a new episode of "Success Files," which is ... events and innovation and investigates each subject in-depth with passion and integrity. , ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of ... Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, ... In honor of Morris F. Collen, a pioneer in the field of medical informatics, ...
(Date:10/12/2017)... ... 2017 , ... Dr. Parsa Mohebi, the Los Angeles based ... the newly revamped Cosmetic Town journal section, featuring articles written by ... as Follicular Unit Extraction (FUE). , Dr. Mohebi says “I enjoy ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global digital ... its MyDario product is expected to appear on The Dr. Oz Show ... Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz Show kicked off ... The segment features ...
(Date:9/25/2017)... Sept. 25, 2017  EpiVax, Inc., a leader ... and immune-engineering today announced the launch of EpiVax ... of personalized therapeutic cancer vaccines. EpiVax has provided ... access to enabling technologies to the new precision ... lead EpiVax Oncology as Chief Executive Officer. Gad ...
(Date:9/22/2017)...  As the latest Obamacare repeal effort moves is ... (R-LA) and Lindsey Graham (R-SC) medical device ... industry is in an odd place.  The industry wants ... tax on medical device sales passed along with the ... increased visits and hospital customers with the funding to ...
Breaking Medicine Technology: