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Aim: Umbilical cord blood (UCB) sourced allografts are promising interventions for tissue regeneration. As applications of these allografts and regulations governing them continue to evolve, we were prompted to identify parameters determining their quality, safety and regenerative potential. Materials & methods: Flow-cytometry, mass-spectrometry, protein multiplexing, nanoparticle tracking analysis and standard biological techniques were employed. Results: Quality attributes of a uniquely processed UCB-allograft (UCBr) were enumerated based on identity (cell viability, immunophenotyping, proteomic profiling, and quantification of relevant cytokines); safety (bioburden and microbiological screening), purity (endotoxin levels) and potency (effect of UCBr on chondrocytes and mesenchymal stem cells derived exosomes). These attributes were stable up to 24 months in cryopreserved UCBr. Conclusion: We identified a comprehensive panel of tests to establish the clinical efficacy and quality control attributes of a UCB-sourced allograft.

Aim: Placental allografts used for tissue regeneration differ in membrane compositions and processing techniques. A uniquely folded dehydrated binate amniotic membrane (DBAM) was biochemically characterized to evaluate its potential role in wound healing. Methods: Histology, Luminex-based immunoassay and standard in vitro cell biology techniques were employed. Results: Histological staining confirmed that the DBAM was chorion free with epithelial cell layer of the respective amnion membranes facing outward. DBAM had quantifiable levels of relevant cytokines that induced proliferation and migration while bolstering secretory activity of the cells. DBAM retained biological efficacy at a broad range of temperatures. Conclusion: Cytokines in DBAM stimulate bone marrow stromal and stem cells that may lead to tissue regeneration and wound healing in a clinical setup.

Aim: Umbilical cord blood (UCB) finds frequent applications in regenerative medicine. We evaluated the role of cytokines present in a uniquely processed, UCB-derived cellular allograft product (UCBp). Materials & methods: Luminex multiplex assay and standard cell biology methods were employed. Results: Study with allografts from 33 donors identified 44 quantifiable cytokines in the UCBp derived conditioned media (CM). The UCBp-CM elevated proliferation and migration rates of mesenchymal stem cells (MSCs) and bone marrow stromal cells. Moreover, UCBp-CM induced secretion of VEGF-A and osteoprotegerin, which promoted angiogenesis of endothelial cells and positively influenced the osteogenic differentiation of MSCs, respectively. Conclusion: Cytokines in UCBp stimulate cellular processes important for bone regeneration, making UCBp an excellent candidate for potential applications in orthopedic procedures like bone non-union and spinal fusion.