publication date: Apr. 25, 2016
Cell Therapy Production, Patient Accrual Suspended at Rosenberg’s Lab at NCI
NIH has suspended the facilities that produce investigational compounds for an NCI laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials.
As a result, no new new patients will be enrolled in affected trials until the issues are resolved, NIH said in a press release.
“There is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken,” the statement reads.
The cell therapy lab is that of Steven Rosenberg, chief of the NCI Surgery Branch and one of the pioneers of immunotherapy.
“The NCI supports the NIH effort to improve our facilities to minimize potential risk to patients. Although it is not ideal to temporarily pause studies to improve the facility, we believe that these renovations will further minimize risk and patients will benefit,” William Dahut, acting scientific director for Clinical Research in the NCI Center for Cancer Research, said in a statement. “We hope to complete the needed renovations in our labs as soon as possible. We look forward to enrolling new patients in the very near future.”
Kite Pharma Inc., a Santa Monica, Calif., company involved in a Cooperative Research and Development Agreement with NCI said that “the cell therapy manufacturing facilities at the National Cancer Institute are undergoing a voluntary internal review by the National Institutes of Health … Continue reading 42-16 Cell Therapy Production, Patient Accrual Suspended at Rosenberg’s Lab at NCI
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