• ALS Crowd News
    • Oct 12, 2019

    NurOwn Stem Cell Therapy for ALS Opens Phase 3 Clinical Trial

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 stemcell@uci.edu   

     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 diane.mckenna-yasek@umassmed.edu   

     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 rstalsresearch@mayo.edu   

     Principal Investigator: Anthony Windebank, MD

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Jacob Ahlstrom

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