Initial Israel adult stem cell trials offer encouragement for ALS patients

By Dave Andrusko

Rabbi Rafael Shmuelevitz

The story that ran yesterday in a newspaper in Israel was so heartwarming you have to remind yourself that if you’ve been skeptical of results attributed to the use of embryonic stem cells, you need to be just as  careful not to go overboard when something just this side of miraculous takes place when adult stem cells are employed.

Especially when the disease is as devastating as amyotrophic lateral sclerosis (ALS), more commonly known as Lou Gehrig’s Disease.

Malkah Fleisher, writing in the Jewish Press, explains that “A clinical trial of ALS patients conducted by Israel’s BrainStorm Cell Therapeutics shows their therapy, NurOwn, is safe and well-tolerated by patients, and not only capable of halting the progress of the illness, but can actually reverse the course of the disease, improving the breathing, muscle strength, and speech capabilities of sufferers with nerve damage in the brain and spine.”

That would have been wonderful in any case, but the patient, Rabbi Rafael Shmuelevitz, is back teaching as he has for the last 30 years—just one month after beginning experimental treatment that transplanted stem cells taken from their own bone marrow and treated with NurOwn stem cell technology!

But it gets better! Rabbi Shmuelevitz is one of thirteen patients, but shouldn’t have been included in the study. He was initially denied entry in the trial because he also suffered from myasthenia gravis—another muscular disease. However, Fleisher writes, he “was ultimately given the therapy as a last-ditch ‘compassionate treatment.’”

“My students understand every word I say.  It’s truly a miracle from Heaven,” the Rabbi said in an interview with Israel’s Channel 2 news.  “I am a new person as a result of the treatment I received.”  In fact “his speech began to improve, his breathing became easier, and he was able to walk unassisted,” Fleisher writes just days after his first treatment.

The trial is designed to evaluate the safety and preliminary efficacy of BrainStorm’s therapy, and is being conducted at Jerusalem’s Hadassah Medical Center. The interim safety report was submitted by the company to Israel’s Health Ministry.

The story is not exactly filled with caution. For example,

“Researchers and doctors caution that, for now, this is an isolated case, but say the findings are extremely encouraging and could signal a medical breakthrough.  The other 12 patients participating in the trial have also witnessed encouraging results, but not to such a grand scale. Patients in the trial were transplanted with stem cells taken from their own bone marrow and treated with NurOwn stem cell technology.”

BrainStorm President Chaim Lebovits “said the preliminary results demonstrate that the stem cells have the potential not only to stop deterioration but perhaps even cure ALS,” according to Reuters.

“The coming phases in the trial will have to prove this, but these results also reaffirm our belief that we have an enormous potential of being successful with less severe indications such as multiple sclerosis and Parkinson’s,” he said.

Fleisher adds, “BrainStorm is awaiting U.S. Food and Drug Administration approval to begin ALS trials at the University of Massachusetts Medical School and Massachusetts General Hospital. Last year, the FDA granted NurOwn orphan drug designation, providing financial incentives for its development.”

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