1 Trillion Cells: Nationwide Children’s Reaches New Milestone for Universal-Donor NK Cell Studies

The Biologics Manufacturing Resource, Nationwide Children’s Cell and Tissue cGMP manufacturing facility, recently achieved a major milestone. The resource has now delivered more than 1 trillion universal donor natural killer (NK) cells to patients. These NK cells are being studied in clinical trials to learn if they can help children and adults with cancer.

“This milestone represents proof-of-concept for central manufacturing, distribution, and safe infusion of an off-the-shelf cell therapy product developed at and manufactured by Nationwide Children’s,” says Dean Lee, MD, PhD, director of the Cellular Therapy and Cancer Immunotherapy (CTCI) program at Nationwide Children’s and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. He is a professor of pediatrics at The Ohio State University College of Medicine and the DiMarco Family Endowed Chair in Cell Based Therapy.

The move away from patient-specific “bespoke” manufacturing has been a high aspiration of the cell therapy field to restrain manufacturing costs and complexity and to improve consistency of the products. In addition to the many patients treated with these universal-donor NK cells here at Nationwide Children’s, they have also been delivered to many patients across the country through participation in multi-institutional clinical trials led by Nationwide Children’s physicians.

The National Marrow Donor Program (NMDP), formerly known as Be The Match, is an important partner in this effort. The CTCI program at Nationwide Children’s began establishing this bank of universal-donor starting material in collaboration with NMDP Biotherapies in 2018, and initiating first-in-human clinical trials of this approach was a major goal of the CTCI program in their 5-year strategic plan.

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