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Circular of Information for the Use of Cellular Therapy Products

(July 2016; Supersedes June 2016 Version)

The Circular of Information (Circular) for the Use of Cellular Therapy Products is intended to be an extension of the cellular therapy product label. It has been prepared and endorsed by a collaborative group of multiple nongovernmental organizations that represent the cellular therapy field. The US Food and Drug Administration and the Health Resources and Service Administration also participated in the development and review process.

The organizations that developed the Circular intentionally limited its scope to only include minimally manipulated cellular therapy products such as peripheral blood progenitor cells, bone marrow, cord blood and leukocytes. The group recognizes there are multiple cellular therapy products that could not be adequately covered in the Circular. To accommodate this, the Circular includes multiple blank pages at the end of the document to allow for the addition of product or facility specific information.

Circular of Information for the Use of Cellular Therapy Products (PDF)