Embryonic stem cell clinical trials

Embryonic Stem Cell Clinical Trial Suddenly Cancelled

In January of 2008, the FDA announced approval of the first human clinical trial using embryonic stem cells. GERON CORPORATION, the California company developing the therapy, practically promised that paralyzed patients would be dancing again within a year.

Despite the hype around Geron’s press releases announcing FDA approval of the first embryonic stem cell clinical trial, the clinical trial was a Phase I trial, designed only to determine the safety of using embryonic stem cells. Phase I clinical trials are not designed to show effectiveness. Geron chose to test their ES cells in recently paralyzed patients, patients who spontaneously improve 50% of the time anyway. Therefore, one would expect some of these patients to improve whether the ES cells had any benefit or not. After injecting ES cells in only 5 of the 8 planned patients, Geron suddenly cancelled the trial and stopped its entire embryonic stem cell research program. They claimed publicly that they did this for economic reasons.

The claims that the trial and program were stopped for economic reasons seems odd since the trial was funded by the CA Institute for Regenerative Medicine, and millions of tax payer dollars had already been given to Geron. Furthermore, Phase I safety trials only cost about $1 million dollars. It is possible that Geron realized that their plans to charge up to $500,000 for the embryonic stem cell therapy would not work in the marketplace.  Who is going to pay $500,000 for tumor forming ES cell therapy when they could pay about $25,000 or less for safe and effective adult stem cell therapies?

The more likely reason that Geron suddenly cancelled the trial and their entire research program is that some negative result was becoming evident in the patients they had injected with ES cells. Since almost 50% of newly paralyzed patients spontaneously recover, one would have expected to hear something about improvements in the people Geron treated. Yet, not a word has come out. That leads us to wonder whether they were seeing detrimental results in these patients. The tax payer, who funded these trials, deserves to know all the facts about why the programs were cancelled.  Despite the cancellation, Geron must continue to watch these patients for 15 years to monitor tumor formation.

One would think the cancellation of Geron’s embryonic stem cell clinical trial and research programs would be big news. Geron was also responsible for bringing embryonic stem cells to the US, having paid for the derivation of the first human embryonic stem cells at the University of Wisconsin. Whether one is in favor of destroying human embryos or against it, the sudden and unexpected cancellation by Geron should be big news, and yet not much information has reached the general public.

Perhaps now federal dollars will be used to advance adult stem cell therapies that are safe.

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