Tupelo

Thanks for this. This trial design (or I suppose I should say its prediction ) was very similar to the Spheramine trials in which I partipated 13 years ago.

The efficacy was to measure Endpoints after transplanting retinal cells (dopamine-producing) from a donor eye, one eye able to provide enough cells for as many as 10,000 patients with Parkinson's . The transplants were not cross- matched in any way and no immunosuppressant meds were required. The delivery of cells to the hippocampal or caudate area was done stereotaxically. ( not sure of this spelling).

I was one of the original six to participate in the open label safety phase. After four years, the phase I participants maintained a nearly 50% improvement of individual baseline symptoms. The investigating physicians were singing Spheramine's praises at a professional conference. in Helsenki. A few weeks later the trial was suddenly halted while phase II results were finalized. The word of mouth reports were that Spheramine trial results from phase II failed miserably to meet its Endpoints. How could that be???

The published results did not make the scene until nearly two years later! I'd like to know how that was acceptable. In my opinion, the explanation as to how they could be singing the trial's praises while reporting that endpoint results were not met could come a few weeks later. This was the same trial but consisting of a larger sampling of participants (6 inthe phase I safety phase, approximately 74 participants in the phase II randomized multi-facility double- blind design).

Both trials used a cell delivery system requiring porcine or pig cells that then encapsulated the cells to be injected via stereotaxic surgery. And remember this important safety factor - NO immunosuppressant drugs we're needed or used which often causes all types of rejection problems.

I would like for a good reputable statistician to compare the trial results and design Tulpedo has provided the above link for to the Spheramine trial. Pig cells vs human donor retinal pigmented epithelial (RPE) cells seems to be the major difference, in my nonprofessional opinion.

We, as people with Parkinson's or other interested individuals (caregivers, friends, family scientists and Parkinson's clinicians) should be asking lots of questions. Both these trials did not carry the stigma most " living cell" transplant trials carry - the belief, ethics, and safety or dangers of using cells such as embryonic cell transplants have carried in the past.

Forgot to include Spheramine link to report
http://www.ncbi.nlm.nih.gov/m/pubmed/18394567/