Comprehensive evaluation of the clinical feasibility of using perinatal medical waste as a source for fetal mesenchymal stem cell banking under good manufacturing practice conditions.

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This study aimed to determine the most feasible perinatal tissue for Good Manufacturing Practice (GMP)-compliant banking of mesenchymal stromal-like cells (MSC-like cells). It was hypothesized that amniotic fluid collected during cesarean section would yield lower contamination rates and greater processing feasibility compared with other perinatal tissues. This prospective observational study was conducted at a tertiary university hospital and included 32 healthy term pregnancies. A total of 160 perinatal samples-amniotic fluid, amniotic membrane, umbilical cord, intact placenta, and placental fragments-were obtained. A validated feasibility scoring system evaluated material acquisition difficulty, transportation logistics, storage duration, and processing complexity. Samples were stratified by delivery mode (cesarean section vs. vaginal delivery) and collection timing (within vs. outside laboratory working hours). Stem cell isolation, sterility assessment, and immunophenotypic characterization were performed. Due to the absence of trilineage differentiation assays and maternal-fetal origin confirmation, the isolated cells were defined as MSC-like cells rather than definitive fetal MSCs. Statistical analyses were performed using chi-square and Mann-Whitney U tests (p < 0.05). Samples collected via cesarean section demonstrated significantly lower rates of blood contamination (25.8% vs. 60.0%, p < 0.001) and bacterial contamination (25.8% vs. 60.0%, p < 0.001) compared with those from vaginal deliveries. Amniotic fluid achieved the highest acquisition score, required no enzymatic digestion, and had the shortest median isolation time (45min). It exhibited the lowest overall contamination and was the most suitable source for GMP-oriented MSC-like cell processing. Conversely, intact placenta and placental fragments showed the highest contamination rates, longest enzymatic processing times, and greatest logistical burden. While collection timing affected storage duration and workflow continuity, tissue type and delivery mode were the dominant determinants of feasibility. Cesarean section-derived amniotic fluid appears to be the most practical, sterile, and processing-efficient perinatal source for GMP-adapted MSC-like cell banking within the evaluated parameters. These results support its prioritization in the development of standardized collection and processing protocols for perinatal stromal cell applications in regenerative medicine.

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Perinatal tissues such as umbilical cord, amniotic fluid, amniotic membrane, and placenta contain mesenchymal stem cells (MSCs) with clinical potential; however, a direct comparison of these sources under Good Manufacturing Practice (GMP) conditions remains limited. To evaluate and compare perinatal tissue types in terms of viable MSC yield, sterility, and GMP-adjusted processing cost in order to identify practically applicable sources for clinical-grade biobanking. A total of 160 perinatal tissue samples were collected from 32 term pregnancies during elective cesarean delivery. Standardized GMP protocols were applied for MSC isolation, sterility screening using automated BACTEC™ culture systems, and immunophenotypic characterization in accordance with ISCT criteria. Multivariate linear regression was used to identify independent predictors of MSC yield. Cost modeling included reagents, labor, and cryostorage within a laboratory-scale GMP setting. Umbilical cord tissue yielded the highest number of viable MSCs (6.5 × 10⁶ ± 0.8 cells/sample), followed by amniotic fluid (5.8 × 10⁶ ± 0.6). Amniotic fluid exhibited the lowest contamination rate (3%), whereas placental tissues demonstrated higher microbial burden (18-21%). Tissue type was the strongest predictor of MSC yield (β = 0.61, p < 0.001). Normalized cost analyses indicated that umbilical cord and amniotic fluid offered the most favorable yield-to-cost profiles. Under current GMP conditions, umbilical cord and amniotic fluid appear to provide the most balanced combination of MSC yield, sterility, and processing cost. These findings support a practical framework for tissue selection and workflow optimization in perinatal MSC biobanking and translational regenerative applications.

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Amniotic fluid is a promising source of autologous cells for disease modeling, drug screening, and regenerative medicine applications. However, current methods of collecting amniotic fluid are invasive, and samples are limited to pregnancies that require amniocentesis or cesarean section. The purpose of this study was to determine whether amniotic fluid cells could be isolated and cultured from amniotic fluid collected during vaginal deliveries. Amniotic fluid samples were obtained during delivery of 4 neonates, 3 of which had been prenatally diagnosed with hypoplastic left heart syndrome (HLHS) in utero. Adherent amniotic fluid cells were assessed for maternal cell contamination, proliferation rate, surface marker expression, and differentiation potential. Amniotic fluid cells were also reprogrammed to induced pluripotent stem cells (iPSCs) and differentiated into functional cardiomyocytes. Amniotic fluid cells collected from vaginal deliveries showed similar surface marker phenotype and differentiation characteristics to amniotic fluid-derived mesenchymal stem cells collected from amniocentesis and cesarean section. Amniotic fluid cells collected during vaginal births of both neonates with HLHS and one neonate with typical heart geometry could be reprogrammed to iPSCs and differentiated to a cardiac lineage with high efficiency. Conclusions and Relevence:These findings suggest that amniotic fluid collected from vaginal births is a readily available source of patient-specific stem cells for banking, in vitro disease modeling, and regenerative medicine applications.

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Human amniotic membranes and amniotic fluid have attracted increasing attention in recent years as a possible reserve of stem cells that may be useful for clinical application in regenerative medicine. Many studies have been conducted to date in terms of the differentiation potential of these cells, with several reports demonstrating that cells from both the amniotic fluid and membrane display high plasticity. In addition, cells from the amniotic membrane have also been shown to display immunomodulatory characteristics both in vivo and in vitro, which could make them useful in an allotransplantation setting. Here, we provide an overview comparing the latest findings regarding the stem characteristics of cells from both the amniotic membrane and amniotic fluid, as well as on the potential utility of these cells for future clinical application in regenerative medicine.

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