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news.BrainStorm Cell Therapeutics and Dana-Farber Cancer Institute have entered into collaboration, under which Dana-Farber will provide cGMP-compliant clean room facilities for the production of BrainStorm's NurOwn stem cell candidate during its upcoming Phase II ALS trial in the US.
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The trial will be conducted at Massachusetts General Hospital (MGH), the University of Massachusetts (UMass) Hospital and the Mayo Clinic.
Dana-Farber’s Connell and O’Reilly Cell Manipulation Core plant will manufacture NurOwn for the MGH and UMass Hospital clinical sites.
BrainStorm CEO Alon Natanson said that the collaboration brings another step forward to develop a potentially effective treatment option for patients with ALS.
"With plans in place at leading institutions like MGH, UMass, Mayo Clinic and Dana-Farber, we believe the company is well positioned to conduct our next Phase II trial at the highest clinical standards and with maximum efficiency," Natanson added.
The trial, which is pending FDA approval, is expected to begin in the second half of 2013.
Phase I/II clinical study of NurOwn technology in patients with ALS demonstrated a significantly slower decline in overall clinical and respiratory function in six patients who received an intrathecal injection of the cells in the six months following treatment, as compared to the three months preceding treatment.