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

NCT03280056 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-02-29

Study results available
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Summary

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

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

BIOLOGICAL

NurOwn® (MSC-NTF cells)

NurOwn® (MSC-NTF): One course of treatment that includes three separate intrathecal injections of 100-125 x 10\^6 cells every 8 weeks NurOwn® (MSC-NTF): Autologous, bone marrow-derived, mesenchymal stem cells secreting neurotrophic factors

OTHER

Placebo

One course of treatment that includes three separate intrathecal injections of Placebo every 8 weeks Placebo: liquid solution in syringe for injection

OTHER

Bone Marrow aspiration

Bone Marrow aspiration

Sponsors & Collaborators

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Brainstorm-Cell Therapeutics

    lead INDUSTRY

Principal Investigators

  • Merit E. Cudkowicz, MD · Massachusetts General Hospital

  • Robert H. Brown, MD, PhD · UMass Medical School

  • Anthony J. Windebank, MD · Mayo Clinic

  • Namita A. Goyal, MD · UC Irvine

  • Robert G. Miller, MD · California Pacific Medical Center (CPM) Research Institute

  • Robert Baloh, MD, Ph.D. · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2020-09-29
Completion
2020-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03280056 on ClinicalTrials.gov