Tuesday, September 28, 2010
For anyone who read my elaborate essay on stem cell therapy for injured central nervous systems and is interested in a follow-up:
This is the first FDA-approved trial of human embryonic stem cell based therapy for spinal cord injury. The trial aims to assess and evaluate safety issues, with the secondary aim to find out if any restoration of function is possible in humans using embryonic stem cells. As opposed to adult stem cells from various sources, embryonic stem cells do have the capability of turning into something else than blood. In this case they're expected to turn into oligodendrocytes. (Not straight from the embryonic stem cells; read more here and here.)
The trial was supposed to start in January 2009 but it was placed on hold by the FDA because some animals developed cysts from the stem cells in the previous, animal study. Now the hold has been lifted (more animal studies were submitted to the FDA; treated animals regained some function).
This trial will enroll 10 participants, all of whom will have to have a very fresh injury: between 7 and 14 days old!
Now comes my opinion: The Corporation that has been working for 10 years to make these so-called progenitor cells (that are to be injected into the participants' spinal cord) out of embryonic stem cells is--very understandably-- pushy about doing this trial, because they want to get paid, and this, if successful, means big money. Now, there is nothing wrong about that.
What is totally wrong is that some "doctors" at quack clinics in developing countries (read: no regulation, no monitoring) are already getting paid, all without any effort to learn anything about stem cells but how to get hold of them; all without animal trials, assessing safety, learning about side effects; all without any real attempt to find out how to make this extremely complicated form of therapy to work or do anything at all. Their various assumptions (e.g. bone marrow stem cells will miraculously turn into neurons and restore function in patients who have been disabled for years) only sound scientific for someone utterly desperate to help their child (parent, sibling, etc.), but do not sound scientific for anyone who has ventured to read anything else on the subject but quack clinics' websites. There is, of course, no science in the Dominican Republic that isn't available in the USA; but in the USA, pushy corporations here or there, you'd have a hard time to get away with experimenting on disabled children of desperate parents (or on any humans for that matter) using untested substances based on as much science as a fairytale, requiring the parents to pay tens of thousands of dollars for the "therapy".
Well, I'm holding my breath! Any promising results of this trial would be wonderful.