Peggy, first let me start out by saying regardless of the trial outcome, you are to be commended for participating in this study, along with everything else you do. Without human volunteers for research studies, it is literally impossible for us to succeed in finding new interventional and symptomatic treatments.

Although the Spheramine trial was before my "PD" time (and I'm not that familiar with it) I believe the issues were very different than the Living Cell Technologies (LCT) pig cell transplantation study I posted. The LCT human trial was halted because of faulty record keeping in the pre-clinical animal studies. When the oversite committee tried to replicate and validate the results from the same data, they realized they had serious research control and data collection issues. What was similar to your study, though, was the inexcusable delay of several years before reporting the issue and data. One thought I have had in this regard is forming a patient led group to review the timeliness of all researchers in posting their trial results. We would stick to PD research. If they are tardy, or don't post at all, they get penalized. We lobby foundation to stop funding them in the future, and we don't participate in their studies. That will get them to either cooperate, or retire.

With regard to the little I know about your Spheramine trial, I guess the classic, and boring, initial response would be the power of the placebo effect in your open label Phase I. I recently read a study reviewing hundreds of PD trials. The placebo effect is VERY strong and long lasting. However, a more interesting response relates to your saying that you didn't have any effect until about the 9th month. The endpoint in the Phase II was only 12 months. So, maybe they just didn't wait long enough to find a positive result. It certainly would seem logical to think that it would take a long time for this type of intervention to start working. A final thought would be just the differences in people. Its possible that the transplant would work with some people, or some forms of PD, and not others. That would sort of negate finding a positive result in a larger study which may not be true in the smaller 6 patient phase I. Remember, only certain types of individuals will volunteer, like you did. Maybe all 6 of you were very homogenous in many traits and that was somehow related to the success of your trial.

Just some thoughts.

Gary