hESC Clinical Trials: And Then There Are Four

By way of Nature Medicine's blog, A Spoonful of Medicine:

Now 4 clinical trials with human embryonic stem cells (hESCs) have been launched; although 3 of these trials are from the same company (Advanced Cell Technology [ACT]) with the same hESCs (retinal pigment cells) for similar diseases (Stardgardt's disease, an inherited form of macular degeneration, and dry age-related macular degeneration [AMD]).

Here's the timeline (derived, in part, from a previous post):

1. In July 2010, the FDA lifted its regulatory hold* on Geron's clinical trial program for hESC-derived oligodendrocytes in subacute spinal-cord injury. The company announced this week that it has now enrolled 4 patients in the study. The "landmark" trial was featured in last week's SF Chronicle. The first unidentified enrollee was profiled by the Washington Post in April.

2. In November 2010, the FDA approved ACT's first trial of retinal pigment cells in patients with Stardgardt's disease (which affects only about 30,000 Americans but is an important disease model for dry AMD—which is much, much more prevalent). The first enrollee was treated in July at UCLA.

3. In January 2011, the FDA gave another nod to ACT to begin its hESC trial in patients with dry AMD. The first enrollee was treated in July at UCLA.

4. The UK Medicine and Healthcare products Regulatory Agency just gave approval to ACT to also conduct a trial of its retinal pigment cells in patients with Stargardt's disease at Moorfields Eye Hospital in London.

The Nature blog adds that ACT is in "late-stage talks" with other global regulators to conduct similar trials elsewhere around the world. News of these advances in clinical development of hESC treatment appears to have already been built into both companies' share prices—which are in the penny range.

* The hold was originally placed owing to preclinical concerns about the development of epithelial cysts at the site of injury.

Transverse section of the thoracic spinal cord from Gray's Anatomy (1918).