Geron & Neuralstem

Two companies that U2FP follows closely, Geron Corp. and Neuralstem, have been in the news this week with reports on their Phase 1 Clinical Trials.  Phase 1 trials are designed to assess safety for a given therapy, the first hurdle that must be cleared before further trials can be initiated to test for efficacy.

After years of preparation and an exhaustive application to the FDA, Geron began the first trial in the USA that uses a treatment derived from human embryonic stem cells.  The science behind the therapy was developed in Dr. Hans Keirstead’s lab at the University of California-Irvine, and targets patients with acute ASIA A complete thoracic spinal cord injuries.  As you can imagine, Geron faces a significant challenge finding subjects who are willing to enter the trial just 7-14 days after injury.

The first patient, however, was successfully enrolled in October, and he recently came forward to reveal his identity and report on his progress.  The good news is that there have been no adverse effects from his treatment, but it is too early to tell what long-term effects the therapy may have.  For a comprehensive, visual report on the Geron science & trial, check out the video of Medical Director Ed Wirth’s presentation at Working 2 Walk.

In January of 2010, Neuralstem began a Phase I trial using its human spinal cord stem cells (HSSC) in ALS patients.  The Neuralstem therapy requires a direct injection of cells into the spinal cord as well as follow-up immunosuppresion drugs, both of which carry potential risks and cause for concern.  Hence the scientific and patient communities have been eagerly awaiting reports.

This past week the trial’s Principal Investigator presented interim safety data on the first 9 patients, showing no unresolved adverse reactions to the cells or the injection technique.  In the words of Neuralstem CEO Richard Garr, “This is significant and, we believe, compelling safety data.”  Neuralstem hopes to use the same techniques from the ALS trial in spinal cord injury patients, and we should all be following their progress with great interest.

U2FP salutes these two companies, as well as the patients and their families who are participating in the trials, for their courage and pioneering efforts in the quest to repair the nervous system through regenerative medicine.

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