Stem cell therapies - painfully slow progress or just a bump in the regulatory road?

As many of you know Geron's promising stem cell therapy (GRNOPC1) for the treatment of debilitating spinal injurie has been put on clinical hold again this month by the FDA due to recent animal data that's been submitted. This isn't unusual for the ultra cautious FDA but it does highlight the challenges of a risk adverse regulatory system and developing truly novel therapeutics.

The FDA instituted clinical hold piqued my interest in how things are currently progressing with other stem cell therapies and applications. The NIH provides a useful overview on the current areas of development, as you'd expect the use of stem cells are broad, from Diabetes, to Heart repair through to attempts to restore Neurological function.

Here's an overview of just some of the promising therapeutic areas published in 2009 in regards to future human stem cell therapies:

• Induced Pluripotent Stem Cells (i.e. Adult stem cells) Able to Produce Live Mice
• Cancer-destroying Cells Generated from Human Embryonic Stem Cells
• Human Corneal Stem Cells Repair Defective Corneas in Mice
• Induced Pluripotent Stem Cell–Derived Working Heart Muscle Cells

Geron is currently a pioneer in pushing for regulatory approval in the US, however the vast potential of this space to genuinely change medicine as we know it has not escaped most major biotech and pharmaceutical company's awareness. My bet is that as soon as a feasible path to approval emerges we will be seeing a lot more of these genuinely novel restorative therapies in larger scale clinical testing!

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