It was interesting to find in this article the planned trial design proposed for a phase II trial does not utilize sham surgery as a placebo control. Here's an example of alternative trial design. Will the FDA accept it?
Excerpt:

"Further refinement of the dosage, dose escalation, and a larger clinical trial is currently being planned to insure reproducibility of these findings. This next clinical trial will
consist of a prospective randomized controlled study and will compare best medical treatment to autologous neural stem cell therapy for advanced Parkinson’s disease. Selection criteria based on severity of the disease and genetic background will be among several other aspects that will be analyzed to provide statistically significant data after primary objectives are met."

http://www.neurogeneration.com/pdf/Levesque-MS.pdf

Although according to his web site this trial remains on "clinical hold".