Saturday, 15 February 2014

Multiple injection of stem cells is feasible

Feldman EL et al. Intraspinal Neural Stem Cell Injections in ALS Subjects: Phase I Trial Outcomes Accepted manuscript online: 7 FEB 2014 03:02AM EST | DOI: 10.1002/ana.24113


Objective: The FDA-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 ALS subjects.
Methods: Preliminary results have been reported on the initial trial cohort of 12 ALS subjects. Here, we describe the safety and functional outcome monitoring results for the final trial cohort, consisting of 6 ALS subjects receiving 5 unilateral cervical intraspinal neural stem cell injections. Three of these subjects previously received 10 total bilateral lumbar injections as part of the earlier trial cohort. All injections utilized a novel spinal-mounted stabilization and injection device to deliver 100,000 neural stem cells per injection, for a dosing range up to 1.5 million cells. Subject assessments included detailed pre- and post-surgical neurological outcome measures.
Results: The cervical injection procedure was well-tolerated and disease progression did not accelerate in any subject, verifying the safety and feasibility of cervical and dual-targeting approaches. Analyses on outcome data revealed preliminary insight into potential windows of stem cell biological activity and identified clinical assessment measures that closely correlate with ALSFRS-R scores, a standard assessment for ALS clinical trials.
Interpretation: This is the first report of cervical and dual-targeted intraspinal transplantation of neural stem cells in ALS subjects. This approach is feasible and well-tolerated, supporting future trial phases examining therapeutic dosing and efficacy.


MS occurs in multiple points in the CNS and so if you are delivering stemcells you may have to inject them into multiple spots. This report shows this is feasible as shown in someone with motor neuron disease

No comments:

Post a Comment

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.