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

Description

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

Study Start Date

August, 28 2017

Estimated Completion Date

July 2019

Interventions

  • Biological: NurOwn® (MSC-NTF cells)
  • Other: Placebo

Study ID

Brainstorm-Cell Therapeutics -- BCT-002-US

Status

Recruiting

Trial ID

NCT03280056

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

200

Sponsor

Brainstorm-Cell Therapeutics

Inclusion Criteria

  • ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
  • Having onset of ALS disease symptoms, including limb weakness within 24 months at the Screening Visit.
  • ALSFRS-R ? 25 at the screening Visit.
  • Upright slow vital capacity (SVC) measure ? 65% of predicted for gender, height, and age at the screening Visit.
  • Participants taking a stable dose of Riluzole are permitted in the study

Exclusion Criteria

  • Prior stem cell therapy of any kind
  • History of autoimmune or other serious disease (including malignancy and immune deficiency)
  • Current use of immunosuppressant medication or anticoagulants (per Investigator discretion)
  • Exposure to any other experimental agent or participation in an ALS clinical trial within 30 days prior to Screening Visit
  • Use of RADICAVA (edaravone injection) within 30 days of screening or intent to use edaravone at any time during the course of the study including the follow up period
  • Use of non-invasive ventilation (BIPAP), diaphragm pacing system or invasive ventilation (tracheostomy)
  • Feeding tube
  • Pregnant women or women currently breastfeeding

Gender

All

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.6 miles Taylor J Mezoian 617-643-0312 TMEZOIAN@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.6 miles Taylor J Mezoian 617-643-0312 TMEZOIAN@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.6 miles Taylor J Mezoian 617-643-0312 TMEZOIAN@mgh.harvard.edu
University of California Irvine Alpha Stem Cell Clinic - Irvine, California 2,587.5 miles Robert Zhou 949-824-3990 stemcell@uci.edu

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