November 2022; 9 (6) Research ArticleOpen Access
Combined Regulatory T-Lymphocyte and IL-2 Treatment Is Safe, Tolerable, and Biologically Active for 1 Year in Persons With Amyotrophic Lateral Sclerosis
Jason R. Thonhoff, James D. Berry, Eric A. Macklin, David R. Beers, Patricia A. Mendoza, Weihua Zhao, Aaron D. Thome, Fabio Triolo, James J. Moon, Sabrina Paganoni, Merit Cudkowicz, Stanley H. Appel
First published August 29, 2022, DOI: https://doi.org/10.1212/NXI.0000000000200019
Jason R. Thonhoff
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
MD, PhDJames D. Berry
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
MDEric A. Macklin
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
PhDDavid R. Beers
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
PhDPatricia A. Mendoza
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
RNWeihua Zhao
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
MD, PhDAaron D. Thome
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
PhDFabio Triolo
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
PhDJames J. Moon
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
PhDSabrina Paganoni
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
MD, PhDMerit Cudkowicz
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
MDStanley H. Appel
From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
MDCombined Regulatory T-Lymphocyte and IL-2 Treatment Is Safe, Tolerable, and Biologically Active for 1 Year in Persons With Amyotrophic Lateral Sclerosis
Jason R. Thonhoff, James D. Berry, Eric A. Macklin, David R. Beers, Patricia A. Mendoza, Weihua Zhao, Aaron D. Thome, Fabio Triolo, James J. Moon, Sabrina Paganoni, Merit Cudkowicz, Stanley H. Appel
Neurol Neuroimmunol Neuroinflamm Nov 2022, 9 (6) e200019; DOI: 10.1212/NXI.0000000000200019
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vol. 9 no. 6 e200019
PubMed:
Online ISSN:
History:
- Received January 26, 2022
- Accepted in final form June 14, 2022
- First Published August 29, 2022.
Copyright & Usage:
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
Author Disclosures
- Jason R. Thonhoff, MD, PhD,
- James D. Berry, MD,
- Eric A. Macklin, PhD,
- David R. Beers, PhD,
- Patricia A. Mendoza, RN,
- Weihua Zhao, MD, PhD,
- Aaron D. Thome, PhD,
- Fabio Triolo, PhD,
- James J. Moon, PhD,
- Sabrina Paganoni, MD, PhD,
- Merit Cudkowicz, MD and
- Stanley H. Appel, MD
- Jason R. Thonhoff, MD, PhD,
- James D. Berry, MD,
- Eric A. Macklin, PhD,
- David R. Beers, PhD,
- Patricia A. Mendoza, RN,
- Weihua Zhao, MD, PhD,
- Aaron D. Thome, PhD,
- Fabio Triolo, PhD,
- James J. Moon, PhD,
- Sabrina Paganoni, MD, PhD,
- Merit Cudkowicz, MD and
- Stanley H. Appel, MD
- From the Houston Methodist Neurological Institute (J.R.T., D.R.B., P.A.M., W.Z., A.D.T., S.H.A.), Houston Methodist Hospital Research Institute, Stanley H. Appel Department of Neurology, Houston, TX; Neurological Clinical Research Institute (J.D.B., S.P., M.C.), Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, MA; Biostatistics Center (E.A.M.), Massachusetts General Hospital, Boston, MA; Harvard Medical School (E.A.M.), Boston, MA; Department of Pediatric Surgery (F.T.), McGovern Medical School, UTHealth-The University of Texas Health Science Center at Houston, Houston, TX; and Center for Immunology and Inflammatory Diseases (J.J.M.), Massachusetts General Hospital, Boston, MA; and Harvard Medical School (J.J.M.), Boston, MA.
- Correspondence
Dr. Appel sappel{at}houstonmethodist.org
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