According to the NATIONAL INSTITUTE FOR SPINAL CORD STATISTICS there are currently 270,000 recorded spinal cord injuries in the US alone. Increasing at a rate of 12,000 annually our particular percentage of the population is minuscule (1). Which leads to the first pitfall for US stem cell research for SCI (spinal cord injury):
- Because of the small percentage of SCI in the US and globally funding for traumatic spinal cord injury treatments and trials are limited. For example two of the major contributors here in the US are private organizations. Both Christopher and Dana Reeve’s foundation as well as the Miami Project To Cure Paralysis are privately funded organizations with their founders being a quadriplegic themselves (2) (3). How do we expect to find a cure without proper funding from government? It’s my opinion that the biggest contribution from our government is the restrictions placed on research by the FDA. Thus further slowing the process of not only treatments for spinal cord injury but dozens of other illnesses from ALS to blindness.
Recently I made a trip to the Miami Project and spoke with one of the individuals directly involved with Schwann cell clinical trials. Currently after two decades of animal trials the FDA finally approved human clinical trials for thoracic and soon cervical patience. However some requirements have led to very few SCI patients being accepted into the trials. For instance out of 500 only 2 were accepted want to cover requirements is the scar on the spine or the lesion can be no bigger than 2 cm (4). Also the FDA only allows for C-5 and reason below to be a part of any study regarding stem cells and spinal cord research here in the US. So the second problem is:
2. The requirements to be a part of any clinical trial first themselves the US rule out 99% of SCI patients. And in looking at the amount of time it took to transition from animal to human trials a further transition into widespread human trials appears to be very far in the future.
Unfortunately for us as well the FDA has rejected embryonic stem cell’s due to possible tumor growth (5) but has approved the Schwann cells even though reportedly by themselves do not repair the spinal cord. “Thus, the endogenous regenerative events that occur after injury fail to repair the spinal cord.” (5) which leads to the 3rd problem:
3. We’re using the wrong stem cell’s due to the fear of a possible tumor created from the embryonic stem cells which are the most pliable the FDA has ruled them out.
So what are we to do? Well in other parts of the world certain restrictions do not exist, certain regulations do not carry over, they are doing the research now on the front lines. So we do what all sick people do when we are looking for a cure we become “stem cell tourists.” Meaning we go to the countries that are doing the trials. Currently there are several places including Panama, Thailand, China, India, to name a few. They have paid for ads on Google directing you to their websites where patients have beaming testimonials concerning their treatment and hope for success.
Why isn’t the US on the forefront of this? Why is our country lagging behind on treatments that could heal and save people like me and millions of others with the potential that stem cells create? Is it that big pharmaceutical companies don’t want cures for diseases that leave people taking meds for decades, insurance companies wanting you to be sick wanting to you to pay your premiums wanting to increase your deductibles? I encourage you to look for private companies doing stem cell research in the US most either go out of business because of lack of funding or sell to companies outside the US. Look up Osiris a company in Maryland which recently sold out because of lack of funding. Has money become so important that health takes a backseat in the US?
I want everyone reading this not to look at it as a conspiracy theory but to think realistically about the state of the US and why we are so far behind other countries. Something needs to change, people need to come together, raise awareness, speak out, not just on Facebook, but in the streets rally behind the causes you believe in, be a part of something.
J Spinal Cord Med. 2012 Jul; 35(4): 197–198.
2. The Miami Project http://www.thebuonicontifund.com/Page.aspx?pid=201
3. Christopher and Dana Reeve Foundation http://www.reevebigidea.org/
5.Spinal Cord Med. 2009 Apr; 32(2): 105–114.