Tag: James Guest
Chief among their worries is insufficient evidence that the therapy works.
Japan has approved a stem-cell treatment for spinal-cord injuries. The event marks the first such therapy for this kind of injury to receive government approval for sale to patients.
“This is an unprecedented revolution of science and medicine, which will open a new era of healthcare,” says oncologist Masanori Fukushima, head of the Translational Research Informatics Center, a Japanese government organization in Kobe that has been giving advice and support to the project for more than a decade.
January 23, 2013 – Doctors at The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, performed the first-ever Food and Drug Administration approved Schwann cell transplantation in a patient with a new spinal cord injury. The procedure, performed at the University of Miami/Jackson Memorial Medical Center, is a Phase 1 clinical trial designed to evaluate the safety and feasibility of transplanting the patient’s own Schwann cells.
“This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. This trial, and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said neurosurgeon Barth Green, M.D., Co-Founder and Chairman of The Miami Project, and Professor and Chair of Neurological Surgery.