GOVERNMENT INTERESTGOVERNMENT SUPPORT CLAUSE [0002] This invention was made with government support under Grant No. EEC-1648035 from the National Science Foundation and Grant Number AR062368 from the National Institutes of Health. The government has certain rights in the invention.BACKGROUND[0003] Bone-marrow derived human mesenchymal stromal cells (hMSCs), also termed mesenchymal stem cells, represent a promising cell therapy candidate for their anti-inflammatory and immunomodulatory properties. Despite almost three decades of clinical development for diverse inflammatory and immune disease indications (Pittenger 2019) no hMSC product has yet to reach the US market. Whereas early phase hMSC clinical research had promising results, setbacks were faced at advanced clinical phases as endpoints failed to be met (Levy 2020; Martin 2019; Wechsler 2021). For example, the multicenter Prochymal? phase III clinical trial (Osiris Therapeutics Inc., now Mesoblast Inc., NCT00366145) of hMSC treatment for steroid-resistant graft-versus-host disease had disappointing outcomes despite promising early phase results (Galipeau 2013). More recently, the US Food and Drug Administration (US FDA) rejected a biological license application (BLA 125706, August 2020) by Mesoblast for a similar hMSC product due to the inability to show defined potency attributes representative of in vivo or clinical performance and resulting lack of assurance in consistent manufacturing processes (FDA 2020).

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[0123] Flow cytometry: For cell isolation from microfluidic system, the hydrogels were removed and placed in solution of collagenase I (0.2-0.5%), bovine serum albumin (0.1-0.2%), CaCl.sub.2) (10 mM) dissolved in DI water for 30 minutes of incubation or until complete degradation with light agitation. For flow cytometry, viability staining was performed using Zombie Viability

DATE PUBLISHED 2024-06-27