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FDA Gives TCA Cellular Therapy Green Light To Proceed With First ALS Adult Stem Cell Trial Using Patient's Own Stem Cells
http://www.medicalnewstoday.com/articles/176059.php
TCA Cellular Therapy, LLC (TCA-CT) announced that the U.S. Food and Drug Administration (FDA) has approved its adult stem cell protocol to conduct Phase I clinical trials to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease).
This is the second FDA-approved protocol for the treatment of ALS using stem cells in the country; and the first using adult stem cells from the same patient. The aim of the Phase I study will assess safety.
ALS afflicts approximately 30,000 Americans. More people die of ALS than Huntington's disease; and the fatalities nearly equal Multiple Sclerosis. The life expectancy of a patient diagnosed with ALS is two to five years.
"I hope that our trial, along with the combined efforts of scientists and patients, will pave the way to breaking the chains of this devastating disease," stated Gabriel Lasala, M.D., president and CEO of TCA Cellular Therapy.
About the Trial
Under the scientific guidance of cellular biologist, Jose J. Minguell, Ph.D., the adult stem cells will be taken from the patient's bone marrow in a simple outpatient procedure. The cells will then be processed in TCA-CT's GMP laboratory and administered to the patient by spinal tap in one of TCA-CT's facilities.
Recruitment for trial patients will commence in the next few weeks. The company anticipates moving into Phase II within a year.
Related Information:
The Washington Post report regarding our center and specialized stem cell treatment Stem cell therapy, a promising novel endeavor for neurological disorders Major ALS breakthrough-common cause of all forms of ALS discovered Imaging Study Shows Slower Growth In Autistic Brains Extending Into Adolescence 'Pushing Limits' - New Drug Strategies For Alzheimer's, Multiple Sclerosis Study Suggests Varying Practice Sessions May Benefit People With Motor Disorders New Drug Strategies for Alzheimer's and Multiple Sclerosis Antiviral Drugs May Slow Alzheimer's Progression Precision With Stem Cells a Step Forward for Treating Multiple Sclerosis, Other Diseases Minority Children Less Likely to Receive CT Scans Following Head Trauma Reassurance for Dementia Sufferers On Impact of Common Drugs Understanding the Beginnings of Embryonic Stem Cells Helps Predict the Future By Reprogramming Skin Cells Into Brain Cells, Scientists Gain New Insights Into Mental Disorders Family History May Have More Important Role Than Previously Thought in Development of Alzheimer Disease Evidence Points to Potential Roles for Cognitive Rehabilitation Therapy in Treating Traumatic Brain Injury, New Drug Target for Alzheimer's, Stroke Discovered New Drug Target for Alzheimer's, Stroke Discovered A Safe Vaccination for Alzheimer's Disease? Think You're in Poor Health? It Could Increase Your Odds of Dementia Models of Autism Show That Gene Copy Number Controls Brain Structure and Behavior Patient-Specific Stem Cells: Major Step Toward Cell-Based Therapies for Life-Threatening Diseases One Quarter of Seniors Over 70 Have Had Silent Strokes Remitting Multiple Sclerosis: Natalizumab Reduces Relapses and Disability Seeds of Destruction in Parkinson's Disease: Spread of Diseased Proteins Kills Neurons Even High-But-Normal Blood Pressure Elevates Stroke Risk Commonly Used Supplement May Improve Recovery from Spinal Cord Injuries Key to Survival of Brain Cells Discovered Correcting Sickle Cell Disease With Stem Cells New Stem Cell Activity Identified in Human Brain New Stem Cell Activity Identified in Human Brain
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