In 2010, Rabbi Rafoel Shmulevitz, head of the Mir Yeshiva in Jerusalem and a three-decade career educator, could hardly speak, breathe, or walk due to the deadly effects of his advanced stage Amyotrophic Lateral Sclerosis, commonly known as ALS or Lou Gehrig’s disease. This neurodegenerative disease eventually claims the life of its victims.
Resigned to life in a wheelchair as his body continued to deteriorate, Shmulovitz reportedly told Israel’s Channel 2 News in July 2012 the progression of his disease had stopped and that he could walk, speak, and teach again just one month after taking part in the world’s first clinical trial, at Hadassah Medical Center, to test the stem-cell therapy drug NurOwn.
Developed by BrainStorm Cell Therapeutics, an Israeli biomedical company, NurOwn is the company’s “proprietary, first-of-its-kind technology.” According to researchers, in the first phase of the trial several of the 24 patients had “considerable improvement.” Four out of six subjects had significant improvement, according to Hadassah Hospital, and the progression of the disease stopped in two of the others.
“These results are extremely encouraging,” said Dimitrios Karussis, head of the department of neurology at the Hadassah Medical Center in Jerusalem, in a statement. Karussis is the principal investigator for the clinical trial.
“The early clinical follow-up of the patients treated with the stem cells shows indications of beneficial clinical effects, such as an improvement in breathing and swallowing ability, as well as in muscular power,” he said.
Researchers believe ALS sufferers develop symptoms when their cells simply die off. To intervene in that process, doctors took stem cells from the subject’s bone marrow and treated them with the NurOwn stem-cell technology, which accelerated the production of BDNF and GDNF, brain cell-derived and glial-cell derived proteins that support the survival and emergence of dopamine-like neurons.
Then, researchers duplicated these stem cells, added growth hormones to them, and injected them intramuscularly into early-stage ALS patients or into the spinal cords of the more advanced-stage patients.
Using a patient’s stem cells ensures the body will accept the cells and it also guards against possible infection from another person’s stem cells.
“Preliminary results demonstrate that the stem cells have the potential not only to stop deterioration, but perhaps even cure ALS,” BrainStorm’s president, Chaim Lebovits, told Reuters.
“The coming phases in the trial will have to prove this,” added Lebovits, “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.”
Rasheda Ali, the daughter of the famous boxing icon and legend, Muhammad Ali, paid a visit to the company’s laboratories at its site at Hadassah Hospital in Jerusalem in August 2012. She is also a board advisor to BrainStorm. Her father has been coping with the debilitating effects of Parkinson’s disease for many years.
Rasheda Ali is known internationally for her advocacy work to further research in the area of neurodegenerative diseases and published the book “I’ll Hold Your Hand So You Won’t Fall: A Child’s Guide to Parkinson’s Disease” (Merit, 2011).
While in Israel, Ali met with Karussis and Prof. Tamir Ben-Hur, a professor of neurology at Hadassah to learn about their most recent successes in the treatment of these brain diseases.
In an interview about the visit, Ali told Foxnewsinsider.com she does this work to help everyone afflicted with these diseases.
“Here at BrainStorm Cell Therapeutics, we are trying to get those answers for millions of people,” she said. “I’m their voice. We’ve been in clinical trials for BrainStorm for years. But going from pre-clinical to clinical is major for us. We’re getting there. “
BrainStorm is anticipating the approval of NurOwn by the U.S. Food and Drug Administration even as conducts its second, more intensive Phase lla trial using NurOwn with 12 more ALS patients.
In this current phase, three cohorts of subjects are receiving increasing doses of combined injections of NurOwn, inside the muscle and inside the spinal cord. They will be followed for six months. Karussis is also leading this second phase.
The company plans to begin Phase II clinical trials in 2013 in three locations in the U.S. — the University of Massachusetts Medical School, Massachusetts General Hospital, and The Mayo Clinic, pending approval from the USFDA.
NurOwn’s availability on the general market for widespread use is projected to take another five years, but the applications for BrainStorm’s stem-cell therapy technique is also expected to benefit other diseases, including MS and Parkinson’s.
“It will hopefully be possible to treat Parkinson’s disease,” Dr. Adrian Harel, the director of research and development at BrainStorm told nocamels.com, “as well as Huntington’s and other nerve diseases.”