Neurotransplantation for patients with subcortical motor stroke: a Phase 2 randomized trial

• DOI: 10.3171/jns.2005.103.1.0038
• Publication Date: 2009-05-13T18:03:52Z
• Authors: Douglas Kondziolka; Gary K. Steinberg; Lawrence Wechsler; Carolyn C. Meltzer; Elaine Elder; James Gebel; Sharon DeCesare; Tudor Jovin; Ross Zafonte; Jonathan Lebowitz; John C. Flickinger; David Tong; Michael P. Marks; Catriona Jamieson; Desiree Luu; Teresa Bell-Stephens; Jeffrey Teraoka
• Keywords: Stroke

Object No definitive treatment exists to restore lost brain function following a stroke. Transplantation of cultured neuronal cells has been shown be safe and effective in animal models stroke Phase 1 human trial. In the present study authors tested usefulness neuron transplantation followed by participation 2-month rehabilitation program compared with alone patients substantial fixed motor deficits associated basal ganglia Methods Human (LBS-Neurons; Layton BioScience, Inc.) were delivered frozen then thawed formulated on morning surgery. The entry criteria this randomized, observer-blinded trial 18 included age between 75 years, completed duration 6 presence deficit that was stable for at least 2 months, no contraindications stereotactic Patients randomized two centers receive either 5 or 10 million implanted 25 sites (seven per group) program, serve as nonsurgical control group (rehabilitation only; four patients). surgical techniques used same both centers. All underwent extensive pre- postoperative testing imaging. received cyclosporine A week before months after primary efficacy measure change European Stroke Scale (ESS) score months. Secondary outcomes Fugl-Meyer, Action Research Arm Test, Impact scores, well results other tests. Nine strokes ischemic origin nine hemorrhagic. 14 who surgery (ages 40–70 years) uncomplicated surgeries. Serial evaluations (maximum 24 months) demonstrated cell-related adverse serological imaging-defined effects. One patient suffered single seizure, another had syncopal event, there burr-hole drainage an asymptomatic chronic subdural hematoma. Four seven (mean improvement 6.9 points) improved ESS scores months; however, significant cell implants (p = 0.756) baseline values 0.06). Compared baseline, wrist movement hand recorded Fugl-Meyer Assessment instrument not Test gross hand-movement 0.017) 0.001) values. On Scale, 6-month daily activities changed 0.045) but 0.056) Everyday Memory test comparison 0.004) Conclusions can produced culture stereotactically into brains due Although measurable noted some translated living well, did find evidence benefit determined outcome measure. This experimental indicates safety feasibility