Transplantation of spinal cordderived neural stem cells for ALS: analysis of phase 1 and 2 trials

JD Glass, VS Hertzberg, NM Boulis, J Riley, T Federici… - Neurology, 2016 - AAN Enterprises
study provides Class IV evidence that for patients with ALS, spinal cord transplantation of
human stem cells … This study lacks the precision to exclude important benefit or safety issues. …

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

EL Feldman, NM Boulis, J Hur, K Johe… - Annals of …, 2014 - Wiley Online Library
… The goals of this phase 1 trial were to assess the safety … neural stem cells in the spinal cord,
and to examine the use of immunosuppression in ALS subjects, using a risk escalation study

Results from phase I clinical trial with intraspinal injection of neural stem cells in amyotrophic lateral sclerosis: a long-term outcome

…, ALS-NSCs Trial Study Group - Stem cells …, 2019 - academic.oup.com
… of more homogenous future phase I, II, and III … : Our study reached the primary endpoint,
and our results underscore that micro-transplantation of cells into the human anterior spinal cord

[HTML][HTML] Human neural stem cell transplantation in ALS: initial results from a phase I trial

…, J Glass, G Sorarù, NM Boulis, AL Vescovi - Journal of translational …, 2015 - Springer
… We transplanted GMP-grade, fetal human neural stem cells … horns of the spinal cord to test
for the safety of both cells and … study on six patients with ALS shows that transplantation of …

[HTML][HTML] A first-in-human, phase I study of neural stem cell transplantation for chronic spinal cord injury

E Curtis, JR Martin, B Gabel, N Sidhu, TK Rzesiewicz… - Cell stem cell, 2018 - cell.com
… of human-spinal-cord-derived neural stem cell (NSI-566) transplantation for the treatment
of chronic spinal cord injury (SCI). In this clinical … for ALS: Analysis of phase 1 and 2 trials. …

[HTML][HTML] Transplantation of human neural progenitor cells secreting GDNF into the spinal cord of patients with ALS: a phase 1/2a trial

RH Baloh, JP Johnson, P Avalos, P Allred… - Nature medicine, 2022 - nature.com
… This study shows that one administration of engineered neural progenitors can provide …
cells and GDNF delivery to the ALS patient spinal cord for up to 42 months post-transplantation. …

Lumbar intraspinal injection of neural stem cells in patients with amyotrophic lateral sclerosis: results of a phase I trial in 12 patients

JD Glass, NM Boulis, K Johe, SB Rutkove… - Stem …, 2012 - academic.oup.com
… in the prospect of transplanting stem cells into the nervous system for the … spinal cordderived
stem cells (HSSCs) into the lumbar … This is a phase I study, focusing on the issues of safety …

Long‐term phase 1/2 intraspinal stem cell transplantation outcomes in ALS

SA Goutman, MB Brown, JD Glass… - Annals of clinical …, 2018 - Wiley Online Library
spinal cord-derived neural stem cell (HSSC) transplantationamyotrophic lateral sclerosis
(ALS); however, previous trials … survival of our study cohort – Ph1/2 ambulatory limb-onset ALS

Intraspinal stem cell transplantation for amyotrophic lateral sclerosis

KS Chen, SA Sakowski, EL Feldman - Annals of neurology, 2016 - Wiley Online Library
spinal cord neural progenitor cells and the pipeline starting from preclinical studies to the
designs of phase I and IIa clinical trials … Although the phase I study was not designed to …

Intraspinal stem cell transplantation in amyotrophic lateral sclerosis: a phase I safety trial, technical note, and lumbar safety outcomes

J Riley, T Federici, M Polak, C Kelly, J Glass… - …, 2012 - journals.lww.com
… Each injection deposited 100 000 neural stem cells derived from a fetal spinal cord. Twelve
patients … This study uses a methodology that has been carefully developed and validated as …