Lumbar Intraspinal Injection of Neural Stem Cells in Patients with Amyotrophic Lateral Sclerosis: Results of a Phase I Trial in 12 Patients
dc.contributor.author | Glass, Jonathan D. | en_US |
dc.contributor.author | Boulis, Nicholas M. | en_US |
dc.contributor.author | Johe, Karl | en_US |
dc.contributor.author | Rutkove, Seward B. | en_US |
dc.contributor.author | Federici, Thais | en_US |
dc.contributor.author | Polak, Meraida | en_US |
dc.contributor.author | Kelly, Crystal | en_US |
dc.contributor.author | Feldman, Eva L. | en_US |
dc.date.accessioned | 2012-07-12T17:24:01Z | |
dc.date.available | 2013-08-01T14:04:40Z | en_US |
dc.date.issued | 2012-06 | en_US |
dc.identifier.citation | Glass, Jonathan D.; Boulis, Nicholas M.; Johe, Karl; Rutkove, Seward B.; Federici, Thais; Polak, Meraida; Kelly, Crystal; Feldman, Eva L. (2012). "Lumbar Intraspinal Injection of Neural Stem Cells in Patients with Amyotrophic Lateral Sclerosis: Results of a Phase I Trial in 12 Patients ." STEM CELLS 30(6): 1144-1151. <http://hdl.handle.net/2027.42/92063> | en_US |
dc.identifier.issn | 1066-5099 | en_US |
dc.identifier.issn | 1549-4918 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/92063 | |
dc.description.abstract | Advances in stem cell biology have generated intense interest in the prospect of transplanting stem cells into the nervous system for the treatment of neurodegenerative diseases. Here, we report the results of an ongoing phase I trial of intraspinal injections of fetal‐derived neural stems cells in patients with amyotrophic lateral sclerosis (ALS). This is a first‐in‐human clinical trial with the goal of assessing the safety and tolerability of the surgical procedure, the introduction of stem cells into the spinal cord, and the use of immunosuppressant drugs in this patient population. Twelve patients received either five unilateral or five bilateral (10 total) injections into the lumbar spinal cord at a dose of 100,000 cells per injection. All patients tolerated the treatment without any long‐term complications related to either the surgical procedure or the implantation of stem cells. Clinical assessments ranging from 6 to 18 months after transplantation demonstrated no evidence of acceleration of disease progression due to the intervention. One patient has shown improvement in his clinical status, although these data must be interpreted with caution since this trial was neither designed nor powered to measure treatment efficacy. These results allow us to report success in achieving the phase I goal of demonstrating safety of this therapeutic approach. Based on these positive results, we can now advance this trial by testing intraspinal injections into the cervical spinal cord, with the goal of protecting motor neuron pools affecting respiratory function, which may prolong life for patients with ALS. S TEM C ELLS 2012;30:1144–1151 | en_US |
dc.publisher | Wiley Subscription Services, Inc., A Wiley Company | en_US |
dc.subject.other | Motor Neuron Disease | en_US |
dc.subject.other | Spinal Cord | en_US |
dc.subject.other | Stem Cells | en_US |
dc.subject.other | Amyotrophic Lateral Sclerosis | en_US |
dc.subject.other | Clinical Trial | en_US |
dc.title | Lumbar Intraspinal Injection of Neural Stem Cells in Patients with Amyotrophic Lateral Sclerosis: Results of a Phase I Trial in 12 Patients | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Molecular, Cellular and Developmental Biology | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA | en_US |
dc.contributor.affiliationother | Department of Neurology, 101 Woodruff Circle, Suite 6000, Atlanta, Georgia 30322, USA | en_US |
dc.contributor.affiliationother | Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA | en_US |
dc.contributor.affiliationother | Department of Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA | en_US |
dc.contributor.affiliationother | Neuralstem, Inc., Rockville, Maryland, USA | en_US |
dc.contributor.affiliationother | Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA | en_US |
dc.identifier.pmid | 22415942 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/92063/1/1079_ftp.pdf | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/92063/2/SC_11-1235_sm_supplTable1.pdf | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/92063/3/SC_11-1235_sm_supplFigure1.pdf | |
dc.identifier.doi | 10.1002/stem.1079 | en_US |
dc.identifier.source | STEM CELLS | en_US |
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dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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