Last week, StemCells, Inc. received FDA authorization to expand its spinal cord injury trial to the United States.
The arrival of this Phase 1/2 study, which is currently ongoing in Switzerland and Canada and involves patients with chronic spinal cord injury, will significantly ease the travel burden for North American patients. Early results from the trial have been promising, showing two patients had gains in sensory function, first seen at 6 months and persisting 12 months after transplantation. No safety issues have been seen.
To date, seven patients from Germany, Norway, Italy, Israel, Canada and the United States have been transplanted at Balgrist University Hospital in Zurich. StemCells is now focused on opening up trial sites in the United States. Information about the clinical trial is available at the ClinicalTrials.gov website of the National Institutes of Health at http://www.clinicaltrials.gov/ct2/show/NCT01321333?lead=StemCells+Inc.&rank=4.
Russo Partners secured coverage of the announcement across industry publications…
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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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