StemCells, Inc. has announced that the first transplantation of the Company’s proprietary human neural stem cell product—HuCNS-SC™— took place yesterday at the Oregon Health & Science University’s (OHSU) Doernbecher Children’s Hospital.
This transplant is the first of six that are planned as part of the Company’s Phase I clinical trial designed to evaluate the safety and preliminary efficacy of HuCNS-SC as a treatment for infantile and late infantile neuronal ceroid lipofuscinosis (NCL).
NCL, which is often referred to as Batten disease, is a rare and fatal neurodegenerative condition afflicting infants and children.
“Dosing of the first Batten's patient is a major milestone for StemCells, Inc., and for the entire stem cell field. It is the culmination of many years of careful and diligent preparation on the part of many dedicated people."
" It is important to remember, however, that this is just the first step in a long and challenging clinical development process,” said Martin McGlynn, President and CEO of StemCells, Inc.
“Our focus at this time is on the health and well-being of the patient. We are grateful for the participation of this family in this landmark trial. Children afflicted by Batten disease are gravely ill, and this family’s courage advances the hope that this trial will lead to a treatment for this devastating disease.”
The Phase I clinical trial is being led by Robert D. Steiner, M.D., F.A.A.P., F.A.C.M.G., vice chairman of pediatric research and head of the Division of Metabolism at Doernbecher Children’s Hospital, and professor of Pediatrics and Molecular & Medical Genetics at OHSU School of Medicine; Nathan Selden, M.D., Ph.D., F.A.C.S., F.A.A.P., Campagna Associate Professor of Pediatric Neurological Surgery and head of the Division of Pediatric Neurological Surgery, Doernbecher and OHSU School of Medicine; and Thomas K. Koch, M.D., F.A.A.P., F.A.A.N., director of Pediatric Neurology and professor of Pediatrics and Neurology at Doernbecher and OHSU School of Medicine.