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Circular of Information for the Use of Cellular Therapy Products

(October 2018; Supersedes July 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 jointly prepared by the AABB Circular of Information Cellular Therapy Task Force, which includes 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 Task Force 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)

Overview of Changes from July 2016 Circular to October 2018 Circular (PDF)