Why did I do it?
My quality of life had diminished significantly when I entered the Spheramine
trials nearly seven years ago. If the disease followed the usual course, I knew
it would continue to worsen. By volunteering I took a risk that my condition
might worsen or I could even die; but, I knew that living with Parkinson's was
equally risky. On one hand I reasoned that if the treatment from this trial
worsened my condition, I had only hastened the inevitable. On the other, not
only would I be receiving care from the best team of researchers, but I would
also be among the first to receive a possible new treatment for PD years ahead
of its release to the public. I also knew that I could eventually help
thousands suffering with the disease.
RPEs (retinal pigment epithelial cells) are dopamine-producing cells that can be obtained from a human donor eye (from an eye bank, rather than a living donor), and are cultured to grow or reproduce in a lab. A neurosurgeon injects the RPE cells into the brain of a person with Parkinson's using a surgical procedure called stereotactic injection. Theoretically, these RPEs act as little sprinklers, helping replace the missing dopamine cells of a person with Parkinson's.
Immunosuppressant drug therapy used to avoid rejection of these donated cells is not required because the cells are delivered via a technique using microscopic encapsulating spherical gel beads (thus, the name Spheramine).
It is also important to note that several thousand patients (approximately 10,000) can be treated from one donated eye. If Spheramine proves successful, one person may be able to leave a legacy of improved health to thousands.
What did researchers learn from Phase I Trials?
Researchers have been monitoring my progress, along with five others who
originally had the Spheramine injection. Last December they published our
results in the Archives of Neurology. One year after the surgery my
group demonstrated a 48 percent average improvement in motor function over
baseline. After two years, we continued to demonstrate sustained improvement.
Four years after the surgery we were still demonstrating continuing average
improvement in motor function of approximately 43%. Not bad for a degenerative
disease.
The Spheramine clinical trials are presently in a Phase II/III status. If this present phase is successful, based on predetermined goals of the study, the FDA has granted Titan permission to proceed with further research under it's Fast Track Program. The Fast Track Program facilitates the development and expedites the review of drug candidates that demonstrate the potential to treat serious or life-threatening diseases, and address unmet medical needs. Some 68 trial participants are required for this phase, with recruitment still open.
When did the trial
participants learn about safety?
Before a patient even agrees to be a part of the trial, a professional member
of the research team explains:
-
What the treatment is
-
What the treatment claims to
do
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How the trial will be
conducted
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Safety factors and risks
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The length of the trial and
associated commitment
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Cost to the patient
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Simple rights of the trial
volunteer
This process is known as an informed consent. When one enters a clinical trial that person becomes the most important part of the trial process. A strong and sincere commitment should be made by entire research team (doctors, nurses, patient, and sponsoring company) to insure the safety and proper treatment of the trial volunteer.
Knowledge indeed is power in protection of the rights of a clinical trial participant. A trial participant should be regarded as the most important resource to the trial process, and therefore, respected as an integral part of the research team. Unfortunately, this is more often the exception and not the rule. I was fortunate to have had excellent sponsoring companies in the Spheramine trials.
Peggy Willocks is one of the Parkinson's disease community's strongest voices. On the local level, she has facilitated multiple support groups for nine years, and volunteered as the Parkinson's Action Network State Coordinator for the State of Tennessee. On the national and international scale she is one of the founding members, of Grassroots Connection, an organization and website that encourages political advocacy that affects people with Parkinson's disease. Her most recent honor was an invitation to serve on the Parkinson Action Network Board of Directors. She works tirelessly to further energy and funding for a Parkinson's disease cure.
If you would like to learn more about participating in the ongoing Spheramine clinical trial, click here to request more information.
Technorati tags: Parkinson's disease, Parkinson's, Peggy Willocks, Spheramine, retinal pigment epithelial, RPE, retina, my parkinson's info.
