On-chip 3D potency assay for prediction of clinical outcomes for cell therapy candidates for osteoarthritis

Rebecca S. Schneider, Elisa B. Nieves, Bhavay Aggarwal, Annie C. Bowles-Welch, Hazel Y. Stevens, Linda E. Kippner, Scott D. Boden, Kenneth Mautner, Hicham Drissi, Krishnendu Roy, Wilbur A. Lam, Saurabh Sinha and Andrés J. García ()
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Rebecca S. Schneider: Georgia Institute of Technology
Elisa B. Nieves: Georgia Institute of Technology
Bhavay Aggarwal: Georgia Institute of Technology and Emory University
Annie C. Bowles-Welch: Georgia Institute of Technology
Hazel Y. Stevens: Georgia Institute of Technology
Linda E. Kippner: Georgia Institute of Technology
Scott D. Boden: Emory University
Kenneth Mautner: Emory University
Hicham Drissi: Emory University
Krishnendu Roy: Georgia Institute of Technology
Wilbur A. Lam: Georgia Institute of Technology
Saurabh Sinha: Georgia Institute of Technology and Emory University
Andrés J. García: Georgia Institute of Technology

Nature Communications, 2025, vol. 16, issue 1, 1-12

Abstract: Abstract The lack of clinically predictive potency assays for cell products significantly impedes translation of these therapies. Here, we describe a microfluidic on-chip 3D system for rapid evaluation of a subset of patient-derived bone marrow aspirate concentrate (BMAC) samples used in a phase 3 multicenter trial (NCT03818737) evaluating autologous cells for relieving knee osteoarthritis pain. BMAC clinical samples cultured in the on-chip 3D system exhibit elevated levels of immunomodulatory and trophic proteins compared to 2D culture. Using analyte information from in vitro assays and patient-matched clinical data, we build linear regression prediction models for clinical outcomes. We demonstrate improved clinical prediction by cross-validation accuracy for the on-chip 3D platform compared to 2D culture. Additionally, on-chip 3D assay metrics display higher correlative power with patient pain scores compared to the 2D assay. This study establishes a potency assay with improved prediction power to accelerate translation of cell therapies.

Date: 2025
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DOI: 10.1038/s41467-025-60158-w

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