Expectations For This Clinical Trial Were to Slow Down ALS Progression; Instead it Reversed One Man’s Symptoms

 

According to a recent article published in News NWA, in 2017 Mark Bedwell, of Fort Smith, Arkansas had been told that based upon the rapid progression of his amyotrophic lateral sclerosis (ALS), he would only have about five years to live.

As expected, the diagnosis was devastating. However, Mark managed to rebound mentally and researched his options. Then he located a clinical trial (NCT03280056) in Worcester, Massachusetts, testing stem cell therapy for patients with ALS.

The exciting news that has researchers, scientists and physicians cautiously optimistic is that after fourteen visits to the clinic in Worcester, Mark has regained his voice and he is able not only to walk but even run.

About ALS

ALS is a neurodegenerative disease. It is also known as Lou Gehrig’s disease, named after the famous baseball player who had it.

Nerve cells (neurons) in the brain and spinal cord are affected. These neurons control voluntary muscle movement (e.g. breathing and walking).

It is a progressive and fatal disease. Therapies now available to ALS patients are able to slow progression very slightly but do not maintain or restore function. Additional information about ALS is available here.

About Phase III NurOwn® Stem Cell Clinical Trial NCT03280056

Dr. Robert Brown, professor at the Medical School at U. Mass., has participated in several clinical trials testing the effects of stem cell therapy for ALS (also see Landers, Brown; NCT01459302).

Dr. Brown explained that the testing of NurOwn®, a novel and innovative stem cell therapy, involves harvesting the stem cells from the bone marrow in the patient’s own body.

The patients in the trial will receive back either their own harvested stem cells or they will be given a placebo via their own spinal fluid.

Further, the trial is double-blinded, meaning that neither the patients nor the doctors know whether a participant has received a placebo or the stem cell treatment.

In the case of Mark Bedwell, Dr. Brown said that it is too early in the trial to know whether Mark has received his own stem cells or a placebo.

Five other NurOwn® clinical trial sites in the United States are in Los Angeles, San Francisco and Irvine, California; Boston Massachusetts; and Rochester, Minnesota.

The sixth and original site is based in Israel through its developer, Brainstorm Cell Therapeutics.

The primary objective of the trial involves an assessment of NurOwn® and to determine whether it is able to improve functional impairment.

The goal of this regimen is to keep the motor neurons alive and healthy. The trial consists of 200 patients and has a completion date of July 2020.

About Brainstorm Cell Therapeutics, Inc.

The company that developed NurOwn®, Brainstorm Cell Therapeutics, is based in Petach Tikvah, Israel with its U.S. facility in Hackensack, N.J.

Brainstorm, a developer of stem cell therapies for neurodegenerative diseases, specializes in a process that engineers a patient’s own cells (autologous) outside the body. This process produces and secretes factors that enable nerve cells to survive.

CONCLUSION 

Several advantages of NurOwn® are:

  • It is autologous
  • Ease of production process
  • Harvesting and delivery of cells is minimally invasive

The data on NurOwn® have been encouraging. The researchers, scientists, and physicians who have been involved in these recent clinical trials believe that the success of stem cells appears to be an attainable goal for the treatment of ALS.

The California Institute for Regenerative Medicine, in support of the program, has awarded a grant of sixteen million dollars.

Have you or anyone you know been involved in any type of stem cell therapy?