Clinical trialNCT03280056CompletedPhase 3Interventional

Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients

SponsorBrainstorm-Cell TherapeuticsEnrollment196Amyotrophic Lateral Sclerosis (ALS)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are enriched from the patient's own bone marrow, propagated ex vivo and induced to secrete Neurotrophic factors (NTFs). The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally by standard lumbar puncture where neurons and glial cells are expected to take up the neurotrophic factors secreted by the transplanted cells

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anthony J. Windebank, MD
Mayo Clinic
Principal Investigator
clinicaltrials.gov ↗
Merit E. Cudkowicz, MD
Massachusetts General Hospital
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Namita A. Goyal, MD
UC Irvine
Principal Investigator
clinicaltrials.gov ↗
Robert Baloh, MD, Ph.D.
Cedars-Sinai Medical Center
Principal Investigator
clinicaltrials.gov ↗
Robert G. Miller, MD
California Pacific Medical Center (CPM) Research Institute
Principal Investigator
clinicaltrials.gov ↗
Robert H. Brown, MD, PhD
UMass Medical School
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California Irvine Alpha Stem Cell Clinic
Irvine, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

NurOwn®

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Aug 2017
Primary completion: 29 Sept 2020
Completion: 29 Sept 2020
Last update posted: 29 Feb 2024
Registered enrollment: 196
Registry id: NCT03280056

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.