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 The Phase II trial will be launched initially at
Massachusetts General Hospital in Boston and the University of
Massachusetts Memorial Hospital in Worcester.
Dana-Farber Cancer Institute's Connell O'Reilly Cell Manipulation
Core Facility will manufacture BrainStorm's NurOwn cells for these
two clinical sites. The trial will also be conducted at the Mayo
Clinic, the Israel-based company said on Sunday. The trials are
expected to start soon.
"Today's announcement represents the most significant milestone
BrainStorm has achieved to date," the company's president, Chaim
Lebovits, said.
This trial will be the first Phase II double-blinded stem cell study
to be conducted for ALS, he added.
ALS, also known as Lou Gehrig's Disease, is a progressive
neurodegenerative disease that affects nerve cells in the brain and
spinal cord.
BrainStorm's Phase II trial is designed to evaluate the safety and
efficacy of transplantation of the stem cells in 48 ALS patients.
The cells will be administered via intramuscular and intrathecal
injection.
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Patients will be followed monthly for three months before
transplantation and for six months following transplantation. Earlier clinical trials have shown that treatment with NurOwn
cells was well tolerated and safe.
Last week, Cytokinetics Inc said its experimental treatment for Lou
Gehrig's Disease failed the main goal in a mid-stage trial.
(Reporting by Tova Cohen)
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