Wooooooooe Horsey! Not so FAST! Patients use caution.
I am apprehensive about Geron’s upcoming embryonic stem cell clinical trial, the first human clinical trial for their experimental drug targeting spinal chord repair. I am especially concerned for the protection of the patients who enroll in this trial
Geron has designed their initial safety trial to only enroll patients with non-severed spinal chord injuries. These injuries are designated as crushing or contusion spinal chord injuries. Geron will be monitoring the outcome of the trial by if a patient can wiggle their toes days or months subsequent to the treatment.
Geron didn’t pick this group of patients without considerable thought to promote their product. In fact, this population of patients is the most likely spinal chord injury population that will make Geron’s drug look good, when indeed it may not be good at all. The reason being is that since their spinal chords have not been severed, these patients have a marked probability of recovering from these injuries to various degrees with or without embryonic stem cell treatment.
Consequently, a “wiggle toe” outcome in Geron’s trial will not project any conclusive data toward determining the efficacy of Geron’s embryonic stem cell drug, but will only provide initial safety information. (Although I can reasonably predict and would actually gamble on the fact that when the first treated patient wiggles his toes, the scientific propaganda machine will undoubtedly tout it as an embryonic stem cell miracle cure to the unsuspecting population. I can see a picture of the toes wiggling already.)
And although the sight of someone wiggling their toes after incurring such a horrific injury to their spinal chord brings joyous emotions to anyone with an ounce of empathy for their suffering, the patient receiving the embryonic stem cell treatment is not home free. They took a risk when entering this trial. A big risk.
The RISK to the patient (who one can imagine is DESPERATE at the time of injury since he is paralyzed, albeit perhaps only temporarily) is incredibly high in undergoing this embryonic stem cell treatment. Even if that said treated patient “wiggles his toes” which he most likely would have done even without the embryonic stem cell treatment, he may very well succumb to a teratoma or auto immune disorder within a ten year period. These risks are well documented in animal studies in the scientific literature regarding embryonic stem cell therapies.
I do hope that these spinal chord injury patients who will be in the unfortunate position to consider entering into Geron’s human embryonic stem cell clinical trial will receive thorough counseling prior to giving consent. I would highly advice those families who have a loved one who will consider entering this trial to seek both objective and independent scientific and legal counsel before signing any consent form. Make sure you understand every sentence in the consent contract…even the small print. Make sure that the experts you choose to counsel with have no conflicts of interest with the Geron trial, which unfortunately is sometimes hard to determine.
Keep in mind that this is a SAFETY trial and not an efficacy trial. Geron’s human embryonic stem cell is a dangerous trial, the safety outcome of which is not only measured within the initial months but decades later.
If you have any questions, contact me at firstname.lastname@example.org.