Our program was the first to evaluate cell transplantation for patients who have suffered a stroke and maintain a significant motor deficit (paralysis or partial paralysis) of arm and/or leg. Although there are ways to prevent stroke, there is no known treatment for stroke once it has occurred and caused a fixed brain injury. Rehabilitation and physical therapy can assist recovery. In this study, cultured human neuronal cells (not fetal tissue) are injected into and around the stroke using minimally invasive stereotactic surgery under local anesthesia.
We used human neuronal cells, called LBS-Neurons (Layton BioScience) that were well characterized and had been evaluated in extensive prior studies in different animal models. After injection into rats with stroke, both motor and behavioral recovery were identified.
The first study was an open-label safety trial with observer-blind neurologic evaluations of patients with cerebral infarction who received stereotactic injections of LBS neuronal cells. A total of 12 patients participated in this phase I study. Neuronal cell injection into the brain around the stroke was performed at one surgical procedure. This study was performed under the United States Food and Drug Administration IND #BB-IND7082, and under the supervision of the University of Pittsburgh Institutional Review Board (IRB #970459). The last surgery in this first trial was completed in March 1999.
A second trial started in February 2001 and was completed in April 2002. Information from the Phase II clinical trial was published in 2005. Please see the article "Neurotransplantation for Patrients with Subcortical Motor Stroke: A Phase II Randomized Trial" in the Journal of Neurosurgery (at right or below) for more information.
We have no open clinical research studies at the present time.
More information on LBS-Neurons for Treating Stroke.