Corporate Banner
Satellite Banner
Stem Cells, Cellular Therapy & Biobanking
>
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Geron Receives FDA Clearance to Begin World's First Human Clinical Trial of Embryonic Stem Cell-Based Therapy

Published: Friday, January 23, 2009
Last Updated: Friday, January 23, 2009
Bookmark and Share
Geron Corporation announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company’s Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.

The clearance enables Geron to move forward with the world’s first study of a human embryonic stem cell (hESC)-based therapy in man. Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.

“The FDA’s clearance of our GRNOPC1 IND is one of Geron’s most significant accomplishments to date,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “This marks the beginning of what is potentially a new chapter in medical therapeutics – one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord.”

GRNOPC1, Geron’s lead hESC-based therapeutic candidate, contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005).

“The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury,” said Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. “Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More than 4,600+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Geron Corporation Appoints Karin Eastham to its Board of Directors
Geron Corporation has announced the appointment of Karin Eastham to its board of directors. Ms. Eastham will also serve as chair of the company’s audit committee.
Monday, March 30, 2009
Geron Issues Statement regarding European Patent Office Decision in WARF Patent Appeal
Geron Corporation announced that the Enlarged Board of Appeals of the European Patent Office (EPO) has issued a decision in case G0002/06, which was an appeal by the Wisconsin Alumni Research Foundation (WARF) against the rejection of claims in WARF’s European Patent Application No. 96903521.1.
Friday, November 28, 2008
Geron Scientists and Collaborators Demonstrate Activity of Pancreatic Islet-like Cells Derived from Human Embryonic Stem Cells in Diabetes
Survival of Diabetic Mice Improved After Transplantation of hESC-derived ILCs.
Tuesday, October 28, 2008
Scientific News
Manufactured Stem Cells to Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Starving Stem Cells May Enable Scientists To Build Better Blood Vessels
Researchers from the University of Illinois at Chicago College of Medicine have uncovered how changes in metabolism of human embryonic stem cells help coax them to mature into specific cell types — and may improve their function in engineered organs or tissues.
Long-Term Culturing of Adult Stem Cells
A new procedure developed by Harvard Stem Cell Institute researchers (HSCI) at Massachusetts General Hospital (MGH) may revolutionize the culturing of adult stem cells.
Naked Mole Rat Exhibits “Extraordinary” Cancer Resistance
Scientists are getting closer to understanding the anti-cancer mechanism of the naked mole rat by making induced pluripotent stem cells.
Solutions for Biotherapeutic Characterization
Innovation to speed the routine.
Reclaiming The Immune System's Assault On Tumors
EPFL study shows a way to reclaim corrupted immune cells.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Body’s Own Gene Editing System Generates Leukemia Stem Cells
Inhibiting the editing enzyme may provide a new therapeutic approach for blood cancers.
Cirrhosis-Causing Cells Converted to Healthy Liver Cells in Mice
New approach that repairs liver from within may be more efficient than cell transplants.
A Boost for Regenerative Medicine
Growing tissues and organs in the lab for transplantation into patients could become easier after scientists discovered an effective way to produce three-dimensional networks of blood vessels, vital for tissue survival yet a current stumbling block in regenerative medicine.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!