ANN ARBOR, Mich. - The U.S. Food and Drug Administration gave the green light Friday for a clinical trial of a new stem cell treatment for amyotrophic lateral sclerosis (ALS). University Michigan neurologist, Eva Feldman, M.D., Ph.D., will be the overall principal investigator for the first human clinical trial of a stem cell treatment for ALS, a fatal neurodegenerative disease.
The FDA approved an Investigational New Drug application from Neuralstem, Inc., a Rockville, Md.-based biotech company, to test the safety of a treatment in which patients will receive injections of the company's patented neural stem cells at multiple sites along the spinal cord.
Director of the U-M ALS Clinic and the U-M Program for Neurology Research & Discovery, Feldman worked with a team of neurologists and with Neuralstem Inc. to develop the protocol for delivering the stem cells into the spinal cord of patients.
The Phase 1 trial to determine the safety of the treatment is expected to take place exclusively at Emory University in Atlanta, Ga., subject to approval by its Internal Review Board.
"We are very excited about this clinical trial," said Feldman, the DeJong Professor of Neurology at the U-M Medical School. "This is a major stride forward in what still could be a long road to a new and improved treatment for ALS.
"ALS is a terrible disease that ultimately kills by paralysis. In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don't want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS," Feldman said.
ALS, also known as Lou Gehrig's disease, affects about 30,000 Americans. It progressively destroys the neurons that control voluntary muscles, leaving affected people unable to move or speak. There are no known treatments for the disease that slow its progression.
The trial will ultimately consist of 18 ALS patients with varying degrees of the disease. The FDA has approved the first stage of the trial, which consists of 12 patients who will receive five-to-ten stem cell injections in the lumbar area of the spinal cord. The patients will be examined at regular intervals post-surgery, with final review of the data to come about 24 months later.
Jonathan Glass, M.D., director of the Emory Neuromuscular Laboratory, is expected to be the site principal investigator for the trial.
Individuals interested in further information on the trial should contact Emory Health Connection, 404-778-7777, or 1-800 75EMORY, or go to http://www.neurology.emory.edu/als
Institutional review boards at U-M and Emory University must first approve the protocol.
If Phase I results are favorable, the treatment will need to prove effective in Phase II and III trials and win final FDA approval before it can be available for public use.
Funding: Neuralstem, Inc. plans to conduct and fund the Phase I trial of its patented technology.
Patents/conflict disclosures: Dr. Feldman has no financial interest in or financial arrangement with Neuralstem.
More here:
First stem cell trial for ALS treatment wins FDA approval ...
- ACT - Stem Cell Trial for AMD and Stargardt - Phase 1 - September 15th, 2011 [September 15th, 2011]
- Excerpt from: "The Urban Wire" Internet Radio Podcast: FDA Oks embryonic stem cell trials for humans - September 15th, 2011 [September 15th, 2011]
- Advanced Cell Technology (ACT) AMD stem cell clinical phase - September 15th, 2011 [September 15th, 2011]
- Stem Cells Retina and cornea regeneration ACT Dr lanza - Advanced Cell Technology - September 15th, 2011 [September 15th, 2011]
- Spinal Patient Receives Stem Cells in First Experimental Treatment - September 15th, 2011 [September 15th, 2011]
- Bloomberg: Geron, StemCells Rise 4% - September 15th, 2011 [September 15th, 2011]
- Bringing Stem Cell Cures to the Clinic: UC Davis GMP Facility - September 15th, 2011 [September 15th, 2011]
- Researchers in California Show Results for Spinal Cord Injuries Using Embryonic Stem Cells - September 15th, 2011 [September 15th, 2011]
- Bill Caldwell, Chairman - September 20th, 2011 [September 20th, 2011]
- Advanced Cell Technology OneMedForum 2011 - September 20th, 2011 [September 20th, 2011]
- ACT edmund vision stem cells program Advanced Cell Technology - September 20th, 2011 [September 20th, 2011]
- Texans for Stem Cell Research Learn for Life: KXAN Coverage Aired August 16th, 2011 - September 20th, 2011 [September 20th, 2011]
- ACT - Dr Lanza - Hermangioblast program - Advanced cell technology - September 23rd, 2011 [September 23rd, 2011]
- Anticipating the Next Decade of the Genome - Francis Collins, Director of NIH - September 24th, 2011 [September 24th, 2011]
- New Epilepsy Treatment Under Study For Seizures - Part 1 - September 24th, 2011 [September 24th, 2011]
- A Thank You For Trevor Raborn - September 24th, 2011 [September 24th, 2011]
- CBLI Breaking News - September 24th, 2011 [September 24th, 2011]
- What is Cord Blood Banking? The Medical Potential of Newborn Stem Cells - September 24th, 2011 [September 24th, 2011]
- Stem cell medical breakthrough? - September 24th, 2011 [September 24th, 2011]
- NIST Colloquium Series: Next Generation Neural Implants - September 24th, 2011 [September 24th, 2011]
- Alan Lewis: Embryonic Stem Cell Therapies for diabetes - September 24th, 2011 [September 24th, 2011]
- 2011 Predictions for Hair Transplant Developments | Arocha Hair Restoration - September 24th, 2011 [September 24th, 2011]
- Healthbeat - Stem Cell Research - September 24th, 2011 [September 24th, 2011]
- Living With ALS - September 24th, 2011 [September 24th, 2011]
- A Revolutionary New Potential Treatment for Glioblastoma... - September 24th, 2011 [September 24th, 2011]
- Lyme Disease: Challenges and Innovations - September 24th, 2011 [September 24th, 2011]
- 2010: Cord blood saving lives [CNN: 5-30-2011] - September 24th, 2011 [September 24th, 2011]
- Biotechnology, Diagnostics, and Genomics: Panel Discussion - September 24th, 2011 [September 24th, 2011]
- Pharmacogenomics - September 24th, 2011 [September 24th, 2011]
- Brickheads - Osteobots Practice Skit.mpg - September 24th, 2011 [September 24th, 2011]
- A veteran lives with ALS - September 26th, 2011 [September 26th, 2011]
- Healthy Body = Functional Body. Hollywood Look Side Effect: Healthy Function - September 26th, 2011 [September 26th, 2011]
- 2009 Flu Summit: Opening Remarks - September 26th, 2011 [September 26th, 2011]
- Cord Blood Breakthrough - September 28th, 2011 [September 28th, 2011]
- SENS5 - Leucocyte transfusions as a novel immunotherapy for cancer patients - October 2nd, 2011 [October 2nd, 2011]
- Lymphoma Drug SGN-35 - The Nebraska Medical Center - October 2nd, 2011 [October 2nd, 2011]
- ACell Hair Restoration with Dr. Gary Hitzig and Dr. Amiya Prasad - Video - October 14th, 2011 [October 14th, 2011]
- Hans Keirstead: Developing therapies based on embryonic stem cells - Video - October 14th, 2011 [October 14th, 2011]
- NJN News Healthwatch Report - Cornea Treatment Study - Video - October 20th, 2011 [October 20th, 2011]
- HIV/AIDS may be prevented by new lubricant - Video - October 22nd, 2011 [October 22nd, 2011]
- MFIII Switzerland PE Sheep Placenta Glandular therapy Study - Client Interviews - Video - October 22nd, 2011 [October 22nd, 2011]
- Love Diabetes: BCG and Noncompliant Patients - Video - October 25th, 2011 [October 25th, 2011]
- Dr. Alimorad Farshchian statement on embryonic stem cells - Video - October 27th, 2011 [October 27th, 2011]
- StemCellTV Daily Report-October 29, 2011 - Video - October 30th, 2011 [October 30th, 2011]
- Stephen McKenna MD - 8 - Video - October 31st, 2011 [October 31st, 2011]
- ALS Stem Cell Trial at Emory - Video - November 22nd, 2011 [November 22nd, 2011]
- Target Product Profile: Ellen Feigal - 2011 CIRM Grantee Meeting - Video - December 6th, 2011 [December 6th, 2011]
- Monoclonal Antibodies: Stanford Academia-Industry Collaboration - Video - December 8th, 2011 [December 8th, 2011]
- Parkinson's Disease Guidelines (Part 2) - Video - December 9th, 2011 [December 9th, 2011]
- Macular Degeneration Drugs - Video - December 13th, 2011 [December 13th, 2011]
- BrainStorm Cell Therapeutics (OTCBB:BCLI) Has Potentially Developed A Treatment For ALS - January 31st, 2012 [January 31st, 2012]
- StemCells, Inc. Receives FDA Authorization for Age-Related Macular Degeneration Clinical Trial - February 3rd, 2012 [February 3rd, 2012]
- Stemedica Cell Technologies - Documentary - Video - February 4th, 2012 [February 4th, 2012]
- (GMCR, STEM, DSCO) CRWENewswire.com Stocks In Action - Video - February 7th, 2012 [February 7th, 2012]
- Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute's Adipose Cell Technology - February 14th, 2012 [February 14th, 2012]
- Neuralstem Announces Closing of $5.2-Million Registered Direct Offering - February 14th, 2012 [February 14th, 2012]
- Scientists Repair Heart Attack Damage Using Patient's Own Stem Cells To Regrow Healthy Heart Muscle - February 14th, 2012 [February 14th, 2012]
- Stem Cells Regrow Healthy Heart Muscle In Heart Attack Patients - February 15th, 2012 [February 15th, 2012]
- Groundbreaking Clinical Trials Study Cord Blood Stem Cells to Help Treat Brain Injury and Hearing Loss - February 17th, 2012 [February 17th, 2012]
- Novelos Therapeutics Announces Enrollment of First Patient in Lung Cancer Trial With I-124-CLR1404 (Light) Cancer ... - February 22nd, 2012 [February 22nd, 2012]
- IntelliCell BioScience Inc. Procedure Enables Norwegian Star Basketball Player to Fully Recover from Patella ... - February 22nd, 2012 [February 22nd, 2012]
- The Lancet Publishes Results from Gentium's Phase III Defibrotide Trial for the Prevention of VOD in Paediatric Patients - February 27th, 2012 [February 27th, 2012]
- Bioheart Issues Shareholder Letter Announcing Progress and New Initiatives - March 1st, 2012 [March 1st, 2012]
- Bioheart Issues Shareholder Letter Announcing Progress - March 1st, 2012 [March 1st, 2012]
- Novelos Therapeutics and Academic Collaborators Have Three Abstracts Accepted for Presentation at 2012 AACR Annual ... - March 1st, 2012 [March 1st, 2012]
- Marshall Edwards Submits Investigational New Drug Application for Oncology Drug Candidate ME-344 - March 6th, 2012 [March 6th, 2012]
- Will StemCells Walk The Talk? - March 7th, 2012 [March 7th, 2012]
- Internationally Recognized Leukemia Physician and Researcher to Lead Sylvester Comprehensive Cancer Center - March 7th, 2012 [March 7th, 2012]
- Criminal investigation after patient dies at office of doctor linked to stem cell - March 9th, 2012 [March 9th, 2012]
- Novelos Therapeutics Announces Enrollment of First Patient in Brain Cancer Trial with I-124-CLR1404 (LIGHT) Cancer ... - March 15th, 2012 [March 15th, 2012]
- Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy - March 20th, 2012 [March 20th, 2012]
- Looking for Innovative Small-Cap Biotech Companies: George Zavoico - March 26th, 2012 [March 26th, 2012]
- Seattle Genetics Announces Pivotal ADCETRIS™ (Brentuximab Vedotin) Hodgkin Lymphoma Study Published in Journal of ... - March 27th, 2012 [March 27th, 2012]
- Gentium Reports Fourth Quarter and Year End 2011 Financial Results - March 28th, 2012 [March 28th, 2012]
- Basketball’s influence on stem cell treatments in sports medicine - March 30th, 2012 [March 30th, 2012]
- Cardium Announces U.S. Market Introduction of Excellagen™ - March 31st, 2012 [March 31st, 2012]
- Optimer Pharmaceuticals, Inc. Announces Presentation at ECCMID of Post-Hoc Subgroup Analysis of DIFICID in Adult ... - March 31st, 2012 [March 31st, 2012]
- New Data Demonstrates DIFICLIR™ May Offer Benefits for Cancer Patients, who are at High Risk of Clostridium Difficile ... - April 1st, 2012 [April 1st, 2012]
- SynGen Inc. Receives $5 million Equity Investment from Bay City Capital, LLC - April 19th, 2012 [April 19th, 2012]
- Gene Ray, Founder of $2.6 Billion Titan Corp, Invests in Medistem's ERC Technology and Joins Advisory Board - April 26th, 2012 [April 26th, 2012]