NurOwn Stem Cell Therapy for ALS Phase 3 Clinical Trial
Notice: This trial is fully accrued as of Friday, October 11th, 2019.
NurOwn therapy is an effort to stop neurodegeneration for ALS at its root. It uses a stem cell platform that involves harvesting mesenchymal stem cells (MSC) and was developed by BrainStorm Cell Therapeutics.
A Phase III trial is now underway and will take place in six cities: Irvine, California; Los Angeles, California; San Francisco, California; Boston, Massachusetts; Rochester, Minnesota; Worcester, Massachusetts.
How Does NurOwn Work?
NurOwn uses stem cells extracted from the patient to harvest specific proteins that are essential in maintaining cell life. These stem cells used in the treatment are called mesenchymal stem cells (MCS). They are precursor cells that can morph into various different types of cells. NurOwn prompts the MSC cells to develop into cells that can be harvested for a specific proteins with neurotrophic factors which may keep cells healthy and prevent cell death. Because MSC are harvested from, treated for, and reinjected into the same patient, they don’t face the challenges of immune response and rejection that proposed cord or embryonic cell therapies do.
There are two ways to inject NurOwn treatment. It can be injected directly into the muscle, this is called the intramuscular or IM method. The other way is to inject it into the spinal canal, known as the intrathecal or IT method.
Prior Clinical Trials
In 2018, Phase 2 trial results were presented at the American Association of Neurological Surgeons conference (AANS) and the Northeast Amyotrophic Lateral Sclerosis consortium meetings (NEALS). These presentations showed improvements in the immune system response and in trial participant’s daily function. This is shown by increased ALSFRS-R (ALS Functional Rating Scale-revised) rates. ALSFRS-R measures an ALS patient’s ability to complete 12 different tasks on a 0-4 scale. Using this scale a physician can rate the patient’s overall functional proficiency on a scale of 0-48 with 48 as the highest possible score.
Phase 1/2 and 2a for NurOwn clinical trials took place in Israel and the Phase III studies are open in the United States. In the Phase III study, patients will be enrolled in two different arms. One arm will receive three doses of the stem cell therapy injected into the spinal column over a 28-week period and the other arm will receive a placebo.
Locations for the Phase 3 trial:
University of California Irvine Alpha Stem Cell Clinic
Irvine, California, United States, 92697
Contact: Robert Zhou 949-824-3990 email@example.com
Principal Investigator: Namita A. Goyal, MD
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Carolyn Prina 310-423-1713 Carolyn.Prina@cshs.org
Principal Investigator: Robert H Baloh, MD
California Pacific Medical Center
San Francisco, California, United States, 94115
Contact: Marian Leon, RN 415-600-1264 LeonMR@SutterHealth.org
Principal Investigator: Robert Miller, MD
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Taylor J Mezoian 617-643-0312 NurOwnPhase3@mgh.harvard.edu
Principal Investigator: James D Berry, MD
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Contact: Diane McKenna-Yasek 508-856-4697 firstname.lastname@example.org
Principal Investigator: Robert H Brown, D.Phil. M.D.
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carol Denny 507-284-2676 email@example.com
Principal Investigator: Anthony Windebank, MD