Transplantation of spinal cord-derived neural stem cells for ALS: Analysis of phase 1 and 2 trials.

Objective: To test the safety of spinal cord transplantation of human stem cells in patients with amyotrophic lateral sclerosis (ALS) with escalating doses and expansion of the trial to multiple clinical centers.

Methods: This open-label trial included 15 participants at 3 academic centers divided into 5 treatment groups receiving increasing doses of stem cells by increasing numbers of cells/injection and increasing numbers of injections. All participants received bilateral injections into the cervical spinal cord (C3-C5).

Analysis of graft survival in a trial of stem cell transplant in ALS.

Objective: The first US Food and Drug Administration-approved clinical trial to treat amyotrophic lateral sclerosis (ALS) with neural stem cell-based therapy is in progress. The goal of the current study was to identify and assess the survival of human spinal cord-derived neural stem cells (HSSCs) transplanted into the spinal cord in patients with ALS.

Methods: Spinal cords transplanted with HSSCs were examined from six autopsy cases.

Intraspinal neural stem cell transplantation in amyotrophic lateral sclerosis: phase 1 trial outcomes.

Objective: The US Food and Drug Administration-approved trial, "A Phase 1, Open-Label, First-in-Human, Feasibility and Safety Study of Human Spinal Cord-Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis, Protocol Number: NS2008-1," is complete. Our overall objective was to assess the safety and feasibility of stem cell transplantation into lumbar and/or cervical spinal cord regions in amyotrophic lateral sclerosis (ALS) subjects.

Methods: Preliminary results have been reported on the initial trial cohort of 12 ALS subjects.

Intraspinal stem cell transplantation in amyotrophic lateral sclerosis: a phase I trial, cervical microinjection, and final surgical safety outcomes.

Background: The first US Food and Drug Administration approved clinical trial for a stem cell-based treatment of amyotrophic lateral sclerosis has now been completed.

Objective: Primary aims assessed the safety of a direct microinjection-based technique and the toxicity of neural stem cell transplantation to the ventral horn of the cervical and thoracolumbar spinal cord. Results from thoracolumbar-only microinjection groups have been previously published.