"We will restore science to its rightful place, and wield technology's wonders to raise healthcare's quality and lower its cost."
President Barack Obama made this promise just 3 days ago during his inauguration address and, as with his plans to examine spending and realign military actions in Guantanamo Bay and Iraq, we're already seeing results.
Today, the FDA cleared a human clinical trial of embryonic stem cell based therapy in patients with acute spinal injury.
Geron Corp., Menlo Park, CA, received approval of its Investigational New Drug application for GRNOPC1. The company will initiate a phase 1 multi-center trial to establish the drug's safety in patients with complete American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.
"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," said Thomas Okarma, PhD, MD, Geron's president and CEO.
"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."
The stem cells are derived from the H1 human embryonic stem cell line, created before Aug. 9, 2001, when former President Bush banned government funding for research using embryonic stem cells.
If successful, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA grade B or C) injuries to enable access to the therapy for a broader population.