Progress you can see – how CIRM-funded projects are heading to clinical trials

Progress in science can take time, and it can seem like a really long slog when so many people are looking to you for breakthroughs that could save their life or the life of someone they love. But progress is being made in stem cell research with a growing number of promising therapies moving out of the lab and into clinical trials in people.

For proof of that here is one slide from a presentation that Dr. Ellen Feigal, our Senior Vice President for Research and Development, made at our March Board meeting. It shows how the Disease Teams we are funding are moving rapidly towards clinical trials. In fact of the first 14 Disease Teams we funded, nine have successfully progressed to the point where they are either already enrolling patients for clinical trials or expect to be enrolling patients by the end of this year, and they just began the CIRM part of their projects in 2010.

The upward slope of the graph above shows how each year more and more of the projects we fund are meeting the targets we have set for them with an ultimate goal of reaching a clinical trial. One of the major milestones in reaching clinical trials is filing the so-called Investigational New Drug (IND) application to the Food and Drug Administration (FDA). This is such an important step that research teams frequently organize “pre-IND” meetings with the FDA to make sure that all their ducks are in a row. Acceptance of the IND is a green light to begin testing the stem cell-based therapy in people.

As you can see from the chart, the IND meetings, filings, and approvals have steadily increased since we begun our Disease Team programs several years ago.

Two trials are already underway, for HIV/AIDS and congestive heart failure (helping patients who have had a heart attack) and other trials are expected to begin this year in:
• Cancer – leukemia and solid tumor cancers (such as breast and ovarian)
• Degenerative eye disease
• Type 1 diabetes
• Sickle Cell disease
• Beta-thalassemia – a serious and potentially deadly blood disorder

This is an impressive rate of success. Of course this is only the first step towards approval by the FDA and there are many challenges facing all of these therapies, but to get this many projects to this point in such a relatively short time is no small achievement.

It’s unlikely that all of these will ultimately work out, but we’re confident some will. And we have many more on the way.

If you would like to see more of Dr. Feigal’s presentation on the progress we are making, with a lot more detail on what these individual projects are and the impact they could have on California and the U.S., you can find it on our website.

kevin mccormack

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