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​Some Patients Report Improvements / Pet Scans Show Improved Glucose Uptake After Neuronal Cell Implant For Stroke

PITTSBURGH, April 28, 1999 — Douglas Kondziolka, M.D., University of Pittsburgh Medical Center (UPMC) department of neurological surgery , reported today on short- and long-term outcome of patients in the world’s first research study of a treatment aimed at reversing neurological deficits from stroke.

His presentation was made at the annual meeting of the American Association of Neurological Surgeons in New Orleans.

Dr. Kondziolka’s study involved 12 patients in a phase I trial evaluating the safety and feasibility of implanting human neuronal cells for treatment of chronic stroke in the basal ganglia region of the brain.

According to Dr. Kondziolka, all patients were discharged from the hospital within 24 hours following the procedure and are currently doing well. One patient subsequently had a single seizure. All MRI scans of patients showed that they were stable. Seven patients report subjective improvements in their motor function, sensation, memory and speech. Such changes are being quantified using validated stroke rating scales.

"PET scans of three out of four patients who are six months post-implant show improved glucose uptake at the implant site. This suggests nerve cell grafting and metabolism," said Dr. Kondziolka, who is professor of neurological surgery and radiation oncology at UPMC and the study’s principal investigator.

Patients in the study were between the age of 40 and 75, whose stroke occurred six months to six years previously and who had a fixed functional motor deficit that had been stable for at least two months. The first four patients in the study received two million cells and the remaining eight were randomized to receive either two or six million cells.

The implanted human neuronal cells are provided by Layton BioScience, Inc., located in Atherton, Calif. LBS-Neurons originate from a human teratocarcinoma found in a 22-year-old cancer patient. Teratocarcinomas are tumors of the reproductive organs that are composed of embryonic-like cells. Layton BioScience, Inc., has licensed a patented process that uses several chemicals to transform this rapidly dividing cell line into fully differentiated, non-dividing human neuronal cells (LBS-Neurons) that can be used in clinical applications. In extensive preclinical testing, implants of LBS-Neurons reversed cognitive and motor deficits in animals in which stroke had been induced.

The procedure begins with the placement of a stereotactic frame on the head of the patient. The frame is a standard tool in neurosurgery to provide a fixed way to find specific locations within the brain. The patient then receives a CT or MRI scan of the brain and the surgical team makes its final decision for location of the human neuronal cells.

Concurrently, the University of Pittsburgh Immunologic Monitoring and Diagnostic Laboratory team thaws the human neuronal cells that were frozen by and transported from Layton BioScience, Inc. Researchers then check the LBS-Neurons to ensure there are the requisite number of viable cells to implant.

After the human neuronal cells are transferred to a long-needled syringe, the surgeon uses CT to guide their injection at multiple sites. The surgeon injects these cells through an opening of the skull smaller than a pea. After injection, the opening is closed with one stitch.

Dr. Kondziolka is currently planning to begin a second, much larger multi-center trial to assess the effectiveness of the treatment.

 

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