Table 2.
Issues of criteria | Conditions |
---|---|
Patient selection | no cognitive impairment |
younger than 65 years old | |
less than 10 years of disease duration | |
no significant L-DOPA-induced dyskinesia | |
Tissue composition | tissue collection in several centers |
transfer of tissue between centers (across national borders) | |
stores up to maximum of 4 days in hibernation medium | |
Tissue placement | standardized instrument for grafting |
delivery of tissue through 5–7 tracts to the posterior putamen | |
Trial design | observation study on 150 patients |
randomized 40 patients in 150 | |
assigned either to transplant/control group | |
1 year immunosuppression | |
Primary end-point | 3 years post-transplantation |
Issues of criteria and the conditions are described, respectively. The patients are selected not to cause graft-induced dyskinesia. Tissue is collected, stored, and transplanted in a stable fashion as a guarantee for the quality of cell transplantation.