AABB and the International Federation for Adipose Therapeutics and Science (IFATS) announced the launch of the 1st edition of Standards for Point of Care, Same Day Adipose Based Therapies. This joint effort focuses on same-day services for the procurement of autologous non-cultured, non-cryopreserved cells and is intended for orthopedics facilities, plastic surgery centers, and academic institutions performing same-day, adipose-based therapies.
Stem cells and, in particular adipose tissue-derived cells, play an important role in tissue or reconstructive medicine. The cellular products covered by this first edition of Standards are treated as minimally manipulated products intended for homologous use by the FDA’s regenerative medicine policy framework.
“The joint AABB/IFATS Standards for adipose-based therapies will offer a measure of quality and safety in this emerging area,” says Eduardo Nunes, MPP, CAE, AABB’s Vice President of Quality Systems, Standards and Accreditation. “Many investigators in this space are seeking support and guidance in their efforts to navigate the clinical trials process and attempt to meet FDA recommendations.”
“AABB and IFATS hope these Standards will provide a platform to help drive regulatory compliance, outcomes reporting and other necessary external evaluation activities in the adipose-based therapies space,” says IFATS Executive Committee member Dr. Adam Katz. “These recommendations will help standardize and improve patient care, providing a means to distinguish those seeking quality and regulatory compliance.”
AABB has been engaged in the development of voluntary standards in blood banking, blood component collection, processing and transfusion since 1957. Since then, AABB’s standards-setting program has moved beyond blood banking to encompass additional related disciplines and activities, including cellular therapies. Providing the basis for AABB Accreditation, AABB’s Standards seek to articulate several critical activities, including qualification for key personnel; collection, auditing and reporting of outcomes data to registries; clinical care of the patient; as well as standard operating procedures and process controls.
AABB will offer a half-day workshop to explain the standards and accreditation process for adipose-based therapies at the IFATS Annual meeting in Marseille, France, on December 4, 2019. The 1st edition of the Standards for Point of Care, Same Day Adipose Based Therapies will be available for public comment on the AABB website through November 19, 2019.