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FDA Approves US Clinical Trials to Treat ALS with Israel Stem Cell Technology

The United States Food and Drug Administration (FDA) has approved the start of multi-center Phase II clinical trials in the United States to treat amyotrophic lateral sclerosis (ALS) with adult stem cell technology first introduced by the Hadassah Medical Organization’s Prof. Dimitrios Karussis, Senior Neurologist and head of Hadassah’s Multiple Sclerosis Center.

The treatment, developed by Israel’s BrainStorm Cell Therapeutics, involves injecting autologous stem cells (coming from the patients themselves) into the spinal fluid. Earlier clinical trials at Hadassah have shown that the treatment was both well tolerated and safe. “Ten of the 15 patients in the Hadassah trials responded or stabilized,” reports Prof. Karussis, “and the disease was halted, with their breathing improved. About three of them even showed that the disease had receded, with them improving dramatically.” He notes, however, that the treatment is not a permanent cure. The injection “probably has to be repeated after several months.”

Trials will begin at Massachusetts General Hospital in Boston and the University of Massachusetts Memorial Hospital in Worcester and later be initiated at the Mayo Clinic in Minnesota.
Read more in The Jerusalem Post

Date: 4/30/2014


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