Posts Tagged ‘ALS’
Background: No US-based clinical trials have attempted delivery of biologic therapies directly to the spinal cord for treatment of ALS, due to the lack of a meaningful FDA-authorized cell candidate and a validated delivery approach.
Objective: To assess safety of delivery of a neural stem cell-based treatment into the upper lumbar segments of the ALS spinal cord in the first FDA-authorized Phase I trial.
Methods: Each microinjection series was comprised of five injections (10[mu]l/inj) separated by 4mm. Each injection deposited 100,000 neural stem cells derived from a fetal spinal cord. Twelve patients were treated with either unilateral or bilateral injections. Group A, non-ambulatory patients, underwent unilateral (n=3) or bilateral (n=3) lumbar microinjections. Groups B and C were ambulatory (n=3 each) and respectively received unilateral or bilateral injections. Patients are followed clinically and radiologically to assess potential toxicity of the procedure.
The Emory Wheel reports that an Emory research team has completed the initial phase of a clinical trial series to implant stem cells into the spinal cords of adults suffering from Lou Gehrig’s disease - the first attempt to do so in the U.S. - on Wednesday.
“In ALS, we believe that the main problem people have is the loss of motor cells, so we started designing a clinical trial, and discussions with the FDA led to a series of experiments to test and prove how we could conduct surgery on humans,” Assistant Professor of Neurosurgery Nicholas Boulis said in a previous interview with the Wheel.