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December 10, 2019; 93 (24) ArticleOpen Access

NurOwn, phase 2, randomized, clinical trial in patients with ALS

Safety, clinical, and biomarker results

James D. Berry, Merit E. Cudkowicz, Anthony J. Windebank, Nathan P. Staff, Margaret Owegi, Katherine Nicholson, Diane McKenna-Yasek, Yossef S. Levy, Natalie Abramov, Haggai Kaspi, Munish Mehra, Revital Aricha, Yael Gothelf, Robert H. Brown
First published November 18, 2019, DOI: https://doi.org/10.1212/WNL.0000000000008620
James D. Berry
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Merit E. Cudkowicz
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Anthony J. Windebank
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Nathan P. Staff
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Margaret Owegi
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Katherine Nicholson
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Diane McKenna-Yasek
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Yossef S. Levy
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Natalie Abramov
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Haggai Kaspi
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Munish Mehra
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Revital Aricha
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Yael Gothelf
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Robert H. Brown
From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
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Citation
NurOwn, phase 2, randomized, clinical trial in patients with ALS
Safety, clinical, and biomarker results
James D. Berry, Merit E. Cudkowicz, Anthony J. Windebank, Nathan P. Staff, Margaret Owegi, Katherine Nicholson, Diane McKenna-Yasek, Yossef S. Levy, Natalie Abramov, Haggai Kaspi, Munish Mehra, Revital Aricha, Yael Gothelf, Robert H. Brown
Neurology Dec 2019, 93 (24) e2294-e2305; DOI: 10.1212/WNL.0000000000008620

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Article Information

vol. 93 no. 24 e2294-e2305
DOI: 
https://doi.org/10.1212/WNL.0000000000008620
PubMed: 
31740545

Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received January 30, 2019
  • Accepted in final form July 30, 2019
  • First Published November 18, 2019.

Article Versions

  • Previous version (November 18, 2019 - 12:45).
  • You are viewing the most recent version of this article.
Copyright & Usage: 
Copyright © 2019 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

    1. James D. Berry, MD,
    2. Merit E. Cudkowicz, MD,
    3. Anthony J. Windebank, MD,
    4. Nathan P. Staff, MD,
    5. Margaret Owegi, MD,
    6. Katherine Nicholson, MD,
    7. Diane McKenna-Yasek,
    8. Yossef S. Levy, PhD,
    9. Natalie Abramov, MSc,
    10. Haggai Kaspi, PhD,
    11. Munish Mehra, PhD,
    12. Revital Aricha, PhD,
    13. Yael Gothelf, PhD and
    14. Robert H. Brown, DPhil, MD
  1. James D. Berry, MD,
  2. Scientific Advisory Boards:
    1. (1) MT Pharma (commercial entity) - attended one-day scientific advisory meeting (2) Denali Therapeutics (commercial entity) - attended one-day scientific advisory meeting (3) Orion Corporation (commercial entity) - attended one- day scientific advisory meeting (4) Maxim Group (commercial entity) - one lecture about ALS research (5) Anelixis Therapeutics (commercial entity) - advisor to company (6) Mayo Clinic (non-profit entity) - DSMB member for ALS stem cell trial

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. (1) ALS Association (non-profit entity) - reimbursed for travel to ALS patient symposium (2) MDA (non-profit entity) - reimbursed for travel to scientific conference (3) ALS One (non-profit entity) - reimbursed for travel to ALS advocacy meeting (4) ALS Finding a Cure (non-profit entity) - reimbursed for travel to ALS research meetings

    Editorial Boards:
    1. Wife (Ann Shinn) - Neuropsychopharmacology - Editorial Board Member

    Patents:
    1. MicroRNAs in neurodegenerative disorders (WO2013055865)

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. (1) Neuraltus Pharmaceuticals - Commercial entity - Site Investigator for Trial (2) Cytokinetics - Commercial entity - Site Investigator for Trial (3) Brainstorm Cell Therapeutics - Commercial entity - Site Investigator for Trial (4) Amylyx Pharmaceuticals - Commercial entity - Site Investigator for Trial (5) MT Pharma - Commercial entity - Principle Investigator for study (6) Biogen - Commercial entity - Principle Investigator for study (7) Genentech - Commercial entity - Site Investigator for Trial

    Research Support, Government Entities:
    1. (1) NIH/NINDS (PI: Steven M. Greenberg) Co-Investigator, 2011-2018 (2) NIH R01DC013547 (PI: Jordan Green) Co-PI, 2014-2019 (3) NIH/NINDS R21 NS101673 (PI: Butovsky) Co-PI, 2017-2019 (4) NIH/NINDS R21 NS104609 (PI: Butovsky) Co-PI, 2018-2020 (5) NIH-R01 DC017291 (PIs: Green and Yunusova) Co-I, 2018- 2023

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. (1) Muscular Dystrophy Association (2) ALS Finding a Cure (3) ALS Association (4) ALS One

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. MicroRNAs in neurodegenerative disorders (WO2013055865) - Licensing royalty

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  3. Merit E. Cudkowicz, MD,
  4. Scientific Advisory Boards:
    1. Lilly DSMB

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. Neurotherapeutics editorial board JAMA Neurology editorial board

    Patents:
    1. Metabolomics in ALS - patent MIR 155 inhibitor - patent

    Publishing Royalties:
    1. UptoDate MND chapter

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. Cytokinetics, Biogen, Orion, ImmunityPharm, Biohaven, Avexis, Revalesio, MT Pharma

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NINDS - U01 NeuroNEXT

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. Muscular dystrophy association, als association, als finding a cure foundation, ALS One

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  5. Anthony J. Windebank, MD,
  6. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. Paracelsus Medical University, Salzburg Austria (Scientific Advisory Board) (travel support only) National University of Ireland Galway, Ireland (CURAM) (Scientific Advisory Board) (travel support only)

    Editorial Boards:
    1. NONE

    Patents:
    1. US Patent #7,163,545 Spinal cord surgical implant

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. (1) BrainStorm Therapeutics - Clinical trial for the use of neurotrophically enhanced autologous stem cells in patients with ALS. Support is only for patient care and investigator effort dedicated to the trial.

    Research Support, Government Entities:
    1. CSCR15IRG002 / FR00081599 Windebank (PI) 5/28/2016 – 5/28/2018 New Jersey Commission on Spinal Cord Research A cell-assembled matrix template to guide nerve regeneration in the spinal cord UL1TR 000135-10 Khosla (PI) 09/01/17 – 08/31/21 NCRR Mayo Clinic Center for Clinical and Translational Research Goal: The goal of the program is to provide infrastructure and education programs to accelerate clinical and translational science. Role: Coinvestigator UL1TR 000135-10 09/01/17 – 08/31/21 NCRR Mayo Clinic Center for Clinical and Translational Research Goal: The goal of this project is to provide education programs for PhD and medical students in clinical and translational science. Role: Principal Investigator W81XWH-14-2-003 Windebank (PI) 01/01/14 – 12/31/18 Department of Defense AFIRM II: Tissue Engineering for repair of critical nerve gaps Goal: This project is to design and test a combination device (scaffolds and cells) for repair of peripheral nerves. Role: Principal Investigator K08CA 169443 (Mentor for Nathan Staff, MD, PhD) 07/01/2012 – 06/30/2017 National Cancer Institute Mechanisms of Bortezomib-induced Peripheral Neuropathy Goal: This project studies the cellular mechanism of Bortezomib-induced peripheral neuropathy. Role: Mentor 2T32EB005583 Kohn (PI) 7/1/2012 – 6/30/2017 NIH/NIBIB Postdoctoral Training in Translational Research in Regenerative Medicine Goal: This NRSA postdoctoral training program offers collaborative research experiences built on core disciplines of biomaterials science, cell biology and pharmaceutical science. A geographically dispersed training community of eight trainees and 15 faculty mentors will engage in translational research to develop regenerative therapies based on tissue engineering, stem cells and drug delivery approaches. Role: Co-Principal Investigator

    Research Support, Academic Entities:
    1. Princeton University Wang (PI) 8/1/2016 – 7/31/2017 Effect of extracellular matrix on promoting nerve regeneration across conduit repaired nerve defects Princeton University Wang (PI) 5/16/2016 – 4/30/2017 Effect of extracellular matrix on promoting nerve regeneration across conduit repaired nerve defects

    Research Support, Foundations and Societies:
    1. Bowen Family Foundation for spinal cord injury research

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  7. Nathan P. Staff, MD,
  8. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Dr. Staff is a co-investigator for the ALS clinical trial from BrainStorm Cell Therapeutics.

    Research Support, Government Entities:
    1. (1)NIH/NCI,(K08)CA169443, PI, 5 years total (completed July 2017) (2)NIH/NCATS, UL1TR 000135-10, co-investigator, 5 years total (in last year) (3)NIH/NCI, (R01)CA215973, co-investigator, 2 years total (4)State of Minnesota, RMM 11215 CT002, PI, 2 years total (in last year)

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. (1) Target ALS

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  9. Margaret Owegi, MD,
  10. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  11. Katherine Nicholson, MD,
  12. Scientific Advisory Boards:
    1. (1) Scientific advisory board for Biohaven Pharmaceuticals (2) Scientific advisory board for Avanir Pharmaceuticals

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. (1) Brainstorm Therapeutics (for role as Co-Investigator)

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. (1) ALS Finding a Cure (2) ALS Association (3) Muscular Dystrophy Association (4) Target ALS (5) Salah Foundation

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  13. Diane McKenna-Yasek,
  14. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. RO1-NS050641-04 salary support for D. McKenna-Yasek

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  15. Yossef S. Levy, PhD,
  16. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. Methods of Generating Mesenchymal Stem Cells which secrete Neurotrophic Factors Method of Qualifying cells

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. Brainstorm Cell Therapeutics, VP Cell Production, 14 years

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Brainstorm Cell Therapeutics Employee

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  17. Natalie Abramov, MSc,
  18. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. Methods for treating Amyotrophic Lateral Sclerosis

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. Brainstorm Cell Therapeutics Research Associate 9 years

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Brainstorm Cell Therapeutics Employee

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  19. Haggai Kaspi, PhD,
  20. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. Methods for treating amyotrophic lateral sclerosis (als)

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. Brainstorm Cell Therapeutics, R&D associate, 3

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  21. Munish Mehra, PhD,
  22. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. Funding for travel for meetings with Brainstorm cell therapeutics team members

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. Tigermed, Director, 3.5 years

    Consultancies:
    1. Brainstorm Cell Therapeutics

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Brainstorm Cell Therapeutics

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  23. Revital Aricha, PhD,
  24. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. METHODS FOR TREATING AMYOTROPHIC LATERAL SCLEROSIS (ALS)

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. Brainstorm Cell Therapeutics employee. VP R&D 4 years

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  25. Yael Gothelf, PhD and
  26. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. NONE

    Patents:
    1. 1) Methods of Generating Mesenchymal Stem Cells which secrete Neurotrophic factors 2) Method of qualifying cells 3) Methods for treating Amyotrophic Lateral Sclerosis

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. Brainstorm Cell Therapeutics Vice President Scientific and Regulatory Affairs 10 years

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Brainstorm Cell Therapeutics - employee

    Research Support, Government Entities:
    1. NONE

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. NONE

    Stock/Stock Options/Board of Directors Compensation:
    1. NONE

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. NONE

    Stock/Stock Options, Research Sponsor:
    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  27. Robert H. Brown, DPhil, MD
  28. Scientific Advisory Boards:
    1. Kirac Foundation ALS Research Laboratory, 2009-2019 Above and Beyond review panel, 2018 Servier - Scientific Advisory Board 2019 Project ALS 2000- ALS - Finding a Cure 2016- NIH - NINDS Board of Scientific Counsellors 2016- Warren Alpert Foundation - Board Member 2018- APIC-Bio Scientific Co-founder and consultant 2018 -

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. Above and Beyond 2018 Kyoto meeting, FP Pharmaceuticals 2018 Servier, Inc 2019

    Editorial Boards:
    1. ALS and Other Motor Neuron Disorders, reviewer, 2008-2015

    Patents:
    1. patent on aspects of superoxide dismutase in ALS, filed 1993

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. Consultant - Voyager Therapeutics - ∼ 2015-2017 APIC-BIO, 2018-2019 Servier - 2019

    Speakers' Bureaus:
    1. NONE

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Wave Lifesciences 2016-2018

    Research Support, Government Entities:
    1. NINDS, RO1, ALS genetics, (R. Brown, PI) NINDS, UO1, ALS therapies (R. Brown, PI)

    Research Support, Academic Entities:
    1. NONE

    Research Support, Foundations and Societies:
    1. ALS Therapy Alliance: SAB and grantee, 2002-2015 Angel Fund for ALS Research: SAB and grantee, 1997-2019 Pierre L. deBourgknecht ALS Research Fund: grantee, 1984- 2019 Day Neuromuscular Research Foundation: grantee, 1984-2019 CureALS, 2014-2015 Project ALS, 1998-2016 ALS-Finding A Cure ∼ 2015-2019 MAPP-One ALS ∼2016-2019 Target ALS - 2016-2019 ALSOne -2-15-2019

    Stock/Stock Options/Board of Directors Compensation:
    1. Voyager Therapeutics - ∼ 2015 Imstar Therapeutics 2017- Amylyx Therapeutics 2017- Warren Alpert Foundation - board of trustees - 2019

    License Fee Payments, Technology or Inventions:
    1. NONE

    Royalty Payments, Technology or Inventions:
    1. Royalty fees from Mass General Hospital, for licensing fees for use of transgenic ALS (SOD1) mice

    Stock/Stock Options, Research Sponsor:
    1. Voyager Therapeutics

    Stock/Stock Options, Medical Equipment & Materials:
    1. NONE

    Legal Proceedings:
    1. NONE

  1. From Massachusetts General Hospital Neurological Clinical Research Institute and Harvard Medical School (J.D.B., M.E.C., K.N.), Boston; Mayo Clinic (A.J.W., N.P.S.), Rochester, MN; University of Massachusetts (M.O., D.M.-Y., R.H.B.), Worcester; Brainstorm Cell Therapeutics (Y.S.L., N.A., H.K., R.A., Y.G.), Petach Tikva, Israel; and Tigermed USA (M.M.), Somerset, NJ.
  1. Correspondence
    Dr. Brown robert.brown{at}umassmed.edu
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