Feasibility and safety of neural tissue transplantation in patients with syringomyelia

Transplantation of fetal spinal cord (FSC) tissue has demonstrated signific ant potential in animal models for achieving partial anatomical and functio nal restoration following spinal cord injury (SCI). To determine whether th is strategy can eventually be translated to humans with SCI, a pilot safety and feasibility study was initiated in patients with progressive posttraum atic syringomyelia (PPTS). A total of eight patients with PPTS have been en rolled to date, and this report presents findings for the first two patient s through 18 months postoperative. The study design included detailed asses sments of each subject at multiple pre- and postoperative time points. Outc ome data were then compared with each subject's own baseline. The surgical protocol included detethering, cyst drainage, and implantation of 6-9-week postconception human FSC tissue. Immunosuppression with cyclosporine was in itiated a few days prior to surgery and continued for 6 months postoperativ ely. Key outcome measures included: serial magnetic resonance imaging (MRI) exams, standardized measures of neurological impairment and functional dis ability, detailed pain assessment, and extensive neurophysiological testing . Through 18 months, the first two patients have been stable neurologically and the MRIs have shown evidence of solid tissue at the graft sites, witho ut evidence of donor tissue overgrowth. Although it is still too soon to dr aw any firm conclusions, the findings from the initial two patients in this study suggest that intraspinal grafting of human FSC tissue is both feasib le and safe.