FDA places hold on ViaCell's clinical trial for umbilical cord blood stem cell transplantation treatment.ViaCell, Inc., Cambridge, MA, announced the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has placed a clinical hold on the company's Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I evaluating CB001, an investigational cord blood cord blood n. Blood present in the umbilical vessels at the time of delivery. stem cell product for hematopoietic stem cell transplantation hematopoietic stem cell transplantation Hematology A therapy in which defective hematopoietic cells are replaced with normal BM cells after chemotherapy and/or RT Indications AML, breast CA, CML, germ cell tumors, lymphoma, myelodysplastic syndrome, myeloma, in patients affected by a variety of cancers. The company says the clinical hold is not in response to any new events in the study. The FDA simply formalized an action ViaCell had taken previously. ViaCell suspended enrollment in its CB001 Phase I clinical trial after two patients experienced Grade IV acute graft-versus-host disease (aGVHD). Under the study protocol, two cases of Grade IV aGVHD called for suspension of enrollment. Both patients recovered from the event. The company says it will continue to work with the FDA to find a way to resume the clinical trials for the CB001 program. Contact: Justine Koenigsberg - (617) 914-3494 |
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