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July 26, 2016; 87 (4) Article

Transplantation of spinal cord–derived neural stem cells for ALS

Analysis of phase 1 and 2 trials

Jonathan D. Glass, Vicki S. Hertzberg, Nicholas M. Boulis, Jonathan Riley, Thais Federici, Meraida Polak, Jane Bordeau, Christina Fournier, Karl Johe, Tom Hazel, Merit Cudkowicz, Nazem Atassi, Lawrence F. Borges, Seward B. Rutkove, Jayna Duell, Parag G. Patil, Stephen A. Goutman, Eva L. Feldman
First published June 29, 2016, DOI: https://doi.org/10.1212/WNL.0000000000002889
Jonathan D. Glass
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Vicki S. Hertzberg
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Nicholas M. Boulis
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Jonathan Riley
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Thais Federici
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Meraida Polak
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Jane Bordeau
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Christina Fournier
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Karl Johe
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Tom Hazel
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Merit Cudkowicz
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Nazem Atassi
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Lawrence F. Borges
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Seward B. Rutkove
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Jayna Duell
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Parag G. Patil
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Stephen A. Goutman
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Eva L. Feldman
From the Departments of Neurology (J.D.G., M.P., J.B., C.F.) and Neurosurgery (N.M.B., J.R., T.F.), Emory University School of Medicine, Atlanta; Center for Nursing Data Science (V.S.H.), Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA; Neuralstem, Inc. (K.J., T.H.), Germantown, MD; Department of Neurology, Neurological Clinical Research Institute (M.C., N.A.), and Department of Neurosurgery (L.F.B.), Massachusetts General Hospital, Boston; Department of Neurology (S.B.R.), Beth Israel Hospital, Boston, MA; and Departments of Neurosurgery (P.G.P.) and Neurology (J.D., P.G.P., S.A.G., E.L.F.), University of Michigan, Ann Arbor, MI.
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Citation
Transplantation of spinal cord–derived neural stem cells for ALS
Analysis of phase 1 and 2 trials
Jonathan D. Glass, Vicki S. Hertzberg, Nicholas M. Boulis, Jonathan Riley, Thais Federici, Meraida Polak, Jane Bordeau, Christina Fournier, Karl Johe, Tom Hazel, Merit Cudkowicz, Nazem Atassi, Lawrence F. Borges, Seward B. Rutkove, Jayna Duell, Parag G. Patil, Stephen A. Goutman, Eva L. Feldman
Neurology Jul 2016, 87 (4) 392-400; DOI: 10.1212/WNL.0000000000002889

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  • Transplantation of spinal cord-derived neural stem cells for ALS: Analysis of phase 1 and phase 2 trials - August 01, 2017
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Abstract

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). The final group received injections into both the lumbar (L2-L4) and cervical cord through 2 separate surgical procedures. Participants were assessed for adverse events and progression of disease, as measured by the ALS Functional Rating Scale–Revised, forced vital capacity, and quantitative measures of strength. Statistical analysis focused on the slopes of decline of these phase 2 trial participants alone or in combination with the phase 1 participants (previously reported), comparing these groups to 3 separate historical control groups.

Results: Adverse events were mostly related to transient pain associated with surgery and to side effects of immunosuppressant medications. There was one incident of acute postoperative deterioration in neurologic function and another incident of a central pain syndrome. We could not discern differences in surgical outcomes between surgeons. Comparisons of the slopes of decline with the 3 separate historical control groups showed no differences in mean rates of progression.

Conclusions: Intraspinal transplantation of human spinal cord–derived neural stem cells can be safely accomplished at high doses, including successive lumbar and cervical procedures. The procedure can be expanded safely to multiple surgical centers.

Classification of evidence: This study provides Class IV evidence that for patients with ALS, spinal cord transplantation of human stem cells can be safely accomplished and does not accelerate the progression of the disease. This study lacks the precision to exclude important benefit or safety issues.

GLOSSARY

AE=
adverse event;
ALS=
amyotrophic lateral sclerosis;
ALSFRS-R=
Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised;
DSMB=
Data Safety and Monitoring Board;
FDA=
US Food and Drug Administration;
FVC=
forced vital capacity;
HSSC=
human spinal cord–derived neural stem cell;
POD=
postoperative day

Footnotes

  • ↵* These authors contributed equally to this work.

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Supplemental data at Neurology.org

  • Editorial, page 348

  • Received November 21, 2015.
  • Accepted in final form March 28, 2016.
  • © 2016 American Academy of Neurology
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