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Biotech / Medical : Neuroscience -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (212)	5/2/2001 5:51:32 PM
From: nigel bates	Read Replies (1) \| Respond to of 278

March 15, 2001 Layton BioSciences' Neurons Enter Phase IIb Stroke Trial NEW YORK (Reuters Health) Mar 15 - A phase IIb trial is set to test whether implanting nerve cells manufactured by Layton Bioscience Inc. can reverse the neurologic effects of stroke in individuals who are left with limited speech and mobility. In the study, which will take place at the University of Pittsburgh Medical Center, in Pennsylvania, investigators expect to implant the nerve cells into 18 patients aged 18 to 75 years. Patients in the trial must have had a stroke in the basal ganglia region of the brain between 1 and 6 years earlier, and the stroke must have resulted in permanent major weakness or partial paralysis. "We expect to quantify the benefits of the procedure [by increasing] the number of cells implanted," Dr. Douglas Kondziolka, principal investigator of the study, told Reuters Health. "We'll gather more information on safety, but [with more cells] we should be able to measure the benefits." In a phase I trial completed two years ago, researchers discovered that half of the 12 patients implanted with Layton's LBS-Neurons demonstrated improvement in motor function one year after implantation. PET scan images, used to measure metabolic activity of the brain around the area of the stroke, also improved in those patients. In the study, patients received between 2 million and 6 million nerve cells. In the latest trial, seven participants will receive 5 million cells while another seven individuals will receive 10 million cells in and around the area damaged by the stroke. For every seven patients implanted with the nerve cells, two will receive no implants. All participants will undergo 8 weeks of rehabilitative physical therapy. As they did with the first trial, researchers will use the European stroke scale to measure improvements in motor skills, said Dr. Kondziolka. Layton manufactures its LBS-Neurons in cultures comprising human cancer cells, retinoic acid and several other chemicals that ultimately help transform the cancer cells into fully differentiated, non-cancerous, non-dividing human neuronal cells, or "pure neurons," according to Dr. Kondziolka. The company then freezes the neurons and sends them to the medical center, where they are thawed and transferred to a long-needle syringe. Using a stereotactic frame on the patient's head and a CT scan as guides, surgeons inject the cells through an opening in the skull to the site of the damaged brain tissue. Following implantation, patients are discharged within 48 hours. Dr. Kondziolka said that all the operations in the phase IIb trial should be completed within 6 months. The follow-up evaluation of the 18 patients will last 1 year...