The breakthrough, first seen in paralyzed animals, was simple and immediately effective. Scientists in Munich harvested stem cells from body fat, concentrated them and then injected them into a preexisting nerve injury. The relocated stem cells rapidly matured into functional neurons, restoring neurologic ability. In the most spectacular case, Yoda, a Doberman Pinscher paralyzed from the waist down, was able to walk and even run after treatment. (You can see a video of the transformation at worldclinic.com/the-stem-cell-miracle, a section of my firm’s website.)
For stem cell scientists, the case confirmed what we all see coming: a new age of medicine where disease and injury are treated through the regeneration of the patient’s own healthy tissue. And for ethicists, the case could resolve political frictions by creating a source of therapies that does not rely on frozen, fertilized human eggs.
Now the research has been extended to human subjects. Though their numbers are small and globally scattered, we are beginning to see similar results among patients with spinal cord injury, advanced parkinsonism and other neurodegenerative disorders.
Here’s what’s happening at the cellular level. A few days after an egg is fertilized, it will have grown into a small ball of 150 to 200 cells. This blastocyst has three layers—endoderm, mesoderm and ectoderm. The cells of each are stem cells, genetically programmed to mature into our solid organs, hollow organs and skin/nerves, respectively. These stem cells are found throughout our bodies, on standby for use if we are injured. If they receive the right signal, they can mature into a specialized cell. The hard parts getting enough of them con-centrated in the right place.
For skin and nerve repairs, the necessary stem cells can be found in our body fat, from which they can be concentrated and delivered to the injury site. If that site is the brain or spinal cord, it appears that the results can be miraculous.
But there’s a catch. Much of the best work being done in stem cells is occurring outside the U.S. In Germany, South Korea, Japan and elsewhere, these nascent cures are being brought to the public much faster than here in the United States. Though the European drug approval process is almost identical to that of our own FDA, its timeline is much shorter. So many people, especially those with neurodegenerative disease, are leaving the U.S. for a chance at a cure elsewhere.
This is not good.
Like most major medical advances, this one is fraught with peril for the initial patients. Fraudsters and quacks are ubiquitous. Defined protocols grounded in validated research don’t exist yet. The reason? This field is moving so fast that we lack the usual double-blind, large scale studies needed to determine what works and what doesn’t. Not coincidentally, this scarcity of data also impedes to FDA approval.
Several states, including Texas, California and Colorado, have attempted to create a regulatory “safe harbor” for stem cell therapies for patients with life-threatening neurodegenerative disease. The FDA response has been mixed, but the agency has shut down several commercial stem cell therapy operations.
Anyone who might benefit from stem cell therapy should recognize that this is a rapidly changing field, so stay on top of research. The New York Times, which hosts a web page on the subject, is a good resource. So is the website of the International Society for Stem Cell Research. If you’re considering going abroad for stem cell therapy, take the time to identify qualified researchers and clinics that regularly post detailed, documented data about outcomes. Avoid any clinic that does not.
No one wants to suffer as a result of an avoidable bureaucratic delay. If you can’t wait—don’t.