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.
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.
- Research Article
- 10.1038/s41598-025-32738-9
- Dec 15, 2025
- Scientific reports
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.
- Research Article
143
- 10.1111/1471-0528.14465
- Mar 16, 2017
- BJOG: An International Journal of Obstetrics & Gynaecology
Management of Breech Presentation: Green-top Guideline No. 20b.
- Research Article
27
- 10.1111/j.0001-6349.2004.00349.x
- Feb 1, 2004
- Acta Obstetricia et Gynecologica Scandinavica
Breech birth at term: vaginal delivery or elective cesarean section? A systematic review of the literature by a Norwegian review team
- Research Article
8
- 10.1111/tmi.13323
- Nov 15, 2019
- Tropical Medicine & International Health
Cesarean delivery on maternal request is one of the important public health issues in China. Our study aimed to apply the theory of planned behaviour to comprehensively determine the factors regarding pregnant women's preference for cesarean section and to provide references for establishing measures to reduce cesarean delivery on maternal request. This cross-sectional analysis was conducted in four women's and children's hospitals in China from May to June 2018. Eligible women arriving for routine antenatal visits at these hospitals were recruited to answer a structured questionnaire. A total of 1853 pregnant women consented to participate in the investigation, with a response rate of 88.75%. Finally, 1677 pregnant women (984 nulliparae and 693 multiparae) were involved in the analysis. Descriptive statistics and logistic regression analyses were used. Of the study participants, 20.39% preferred cesarean section. For both nulliparae and multiparae, those who had lower scores of attitudes towards vaginal delivery, lower scores of childbirth self-efficacy and higher scores of subjective norms were more likely to prefer cesarean section. Pregnant women's birth preferences were significantly associated with their attitudes towards the delivery mode, childbirth self-efficacy and subjective norms, which is consistent with the theory of planned behaviour. Interventions to reduce cesarean delivery on maternal request can be developed based on the theory of planned behaviour.
- Research Article
32
- 10.1007/s11060-016-2302-y
- Oct 18, 2016
- Journal of Neuro-Oncology
Gene profiling has revealed that malignant gliomas can be divided into four distinct molecular subtypes, where tumors with a mesenchymal gene expression are correlated with short survival. The present investigation was undertaken to clarify whether human malignant gliomas contain endogenous mesenchymal stromal cells (MSC), fulfilling consensus criteria defined by The International Society for Cellular Therapy, recruited from the host. We found that MSC-like cells can be isolated from primary human malignant gliomas. Two distinct MSC-like cell populations, differing in their expression of the CD90 surface marker, were discovered after cell sorting. RNA sequencing revealed further genetic differences between these two cell populations and MSC-like cells lacking CD90 produced higher amounts of VEGF and PGE2 compared to cells with the true MSC phenotype, implying that the CD90− MSC-like cells most probably are more active in tumor vascularization and immunosuppression than their CD90+ counterpart. The results highlight the CD90− subpopulation as an important tumor component, however, its functional effects in glioma remains to be resolved. Using the protocols presented here, it will be possible to isolate, characterize and analyze brain tumor-derived MSC-like cells in more detail and to further test their functions in vitro and in in vivo xenograft models of glioma.
- Research Article
39
- 10.1155/2013/259187
- Jan 1, 2013
- BioMed Research International
Background. Although pathological involvements of diabetic polyneuropathy (DPN) have been reported, no dependable treatment of DPN has been achieved. Recent studies have shown that mesenchymal stem cells (MSCs) ameliorate DPN. Here we demonstrate a differentiation of induced pluripotent stem cells (iPSCs) into MSC-like cells and investigate the therapeutic potential of the MSC-like cell transplantation on DPN. Research Design and Methods. For induction into MSC-like cells, GFP-expressing iPSCs were cultured with retinoic acid, followed by adherent culture for 4 months. The MSC-like cells, characterized with flow cytometry and RT-PCR analyses, were transplanted into muscles of streptozotocin-diabetic mice. Three weeks after the transplantation, neurophysiological functions were evaluated. Results. The MSC-like cells expressed MSC markers and angiogenic/neurotrophic factors. The transplanted cells resided in hindlimb muscles and peripheral nerves, and some transplanted cells expressed S100β in the nerves. Impairments of current perception thresholds, nerve conduction velocities, and plantar skin blood flow in the diabetic mice were ameliorated in limbs with the transplanted cells. The capillary number-to-muscle fiber ratios were increased in transplanted hindlimbs of diabetic mice. Conclusions. These results suggest that MSC-like cell transplantation might have therapeutic effects on DPN through secreting angiogenic/neurotrophic factors and differentiation to Schwann cell-like cells.
- Discussion
2
- 10.1016/j.jaci.2011.11.040
- Dec 28, 2011
- The Journal of Allergy and Clinical Immunology
The mediating effect of microbial colonization on the effect of cesarean section delivery
- Research Article
7
- 10.5455/msm.2018.30.290-293
- Jan 1, 2018
- Materia socio-medica
Introduction:The method of carrying out PTB is one of the most controversial topics of modern perinatology, because there are no clear and undeniable works and studies that would in any case support vaginal delivery (VD) or delivery to the cesarean section (CS).Aim:To determine more frequent mode of delivery in different groups of birth weights and degrees of prematurity from single and twin pregnancies. To determine the degree of vitality of premature born vaginal delivery (VD) in relation to the cesarean section (CS) in different degrees of prematurity from single and twin pregnancies. Patients and methods:Research has retrospective cohort character. Data were collected from the databases of University Clinic of Gynecology and Obstetrics Tuzla for the period of five years (January 1st, 2012–December 31st, 2016). The study included newborns of both genders, gestational age from 24 to 37 weeks of gestation (WG) in singleton and twin pregnancies.Results:Out of 19506 births, 1350 (6.92%) were preterm birth (PTB). Singleton PTB was 1180 (87.40%), and the twins were 170 (12.59%). Vaginal delivery (VD) was born 788 (58.37%). Cesarean section (CS) was born 562 (41.63%). There was statistically significant association between the mode of delivery (MD) in singleton and twins pregnancy in all three subgroups of birth weight (BW) 1000-1499, 2000-2499 and >2500 grams in 33-37 WG. In this group was more frequent VD than CS mode of singleton delivery, and CS than VD mode of twins delivery. In contrast to newborn with BW 1500-1999 grams (chi-square = 23.16, P <0.0001) in same gestational period where was more frequent CS than VD (OR: 2.56, 95% CI: 1.71-3,85). Apgar score (AS) at first and five minute 5-7 and 8-10 in the period 28-32 and 33-37 was a statistically significant frequent in VD and singletons in contrast to CS and twins.Conclusion:VD was more frequent in the higher WG, as well as the higher AS in singletons in contrast to twins delivery.
- Research Article
- 10.1371/journal.pone.0337907
- Dec 19, 2025
- PloS one
Cesarean section rates have risen globally. While a cesarean section offers benefits, it is associated with complications like infection, fluid collection, and wound dehiscence. The psychological impact of cesarean section scars can also affect women's quality of life. Amniotic membrane and fluid have shown promise in enhancing wound healing due to their rich content of growth factors and nonimmunogenic properties. This study aims to assess the effects of autologous amniotic membrane and amniotic fluid on wound healing, surgical site infection, pain, and complications following cesarean section. This controlled, randomized, double-blind (participants and the physician assessing outcomes are blinded), 2 × 2 factorial trial with a sample size of 228 is being conducted at Arash Women's Hospital, Tehran, Iran. It involves four groups: amniotic membrane dressing, amniotic fluid spray, a combination of both, and one group receiving standard of care, assessing the effects of autologous amniotic membrane and amniotic fluid on cesarean section wound healing, infection, pain, and complications. Primary outcome (wound healing) would be measured by the Patient and Observer Scar Assessment Scale. Secondary outcomes are surgical site infection, pain via the Visual Analog Scale, surgical wound dehiscence, seroma, hematoma, and bleeding. Results will be analyzed using two-way ANOVA and logistic regression. This research protocol is the first to examine autologous amniotic membrane and amniotic fluid effects on cesarean section scar healing and complications. If effective, amniotic membrane and amniotic fluid could enhance CS scar aesthetics and reduce complications without extra cost. This trial was registered at the Iranian Registry of Clinical Trials (Registration number: IRCT20220408054454N1, Registration date: 2024-07-15).
- Research Article
- 10.1093/stcltm/szaf017
- Jun 25, 2025
- Stem cells translational medicine
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.
- Research Article
- 10.1371/journal.pone.0337907.r008
- Dec 19, 2025
- PLOS One
BackgroundCesarean section rates have risen globally. While a cesarean section offers benefits, it is associated with complications like infection, fluid collection, and wound dehiscence. The psychological impact of cesarean section scars can also affect women’s quality of life. Amniotic membrane and fluid have shown promise in enhancing wound healing due to their rich content of growth factors and nonimmunogenic properties. This study aims to assess the effects of autologous amniotic membrane and amniotic fluid on wound healing, surgical site infection, pain, and complications following cesarean section.Materials and methodsThis controlled, randomized, double-blind (participants and the physician assessing outcomes are blinded), 2 × 2 factorial trial with a sample size of 228 is being conducted at Arash Women’s Hospital, Tehran, Iran. It involves four groups: amniotic membrane dressing, amniotic fluid spray, a combination of both, and one group receiving standard of care, assessing the effects of autologous amniotic membrane and amniotic fluid on cesarean section wound healing, infection, pain, and complications. Primary outcome (wound healing) would be measured by the Patient and Observer Scar Assessment Scale. Secondary outcomes are surgical site infection, pain via the Visual Analog Scale, surgical wound dehiscence, seroma, hematoma, and bleeding. Results will be analyzed using two-way ANOVA and logistic regression.DiscussionThis research protocol is the first to examine autologous amniotic membrane and amniotic fluid effects on cesarean section scar healing and complications. If effective, amniotic membrane and amniotic fluid could enhance CS scar aesthetics and reduce complications without extra cost.Trial registrationThis trial was registered at the Iranian Registry of Clinical Trials (Registration number: IRCT20220408054454N1, Registration date: 2024-07-15).
- Research Article
161
- 10.2217/17460751.4.2.275
- Mar 1, 2009
- Regenerative Medicine
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.
- Abstract
1
- 10.1016/j.jaci.2004.12.816
- Feb 1, 2005
- Journal of Allergy and Clinical Immunology
Assessment of the association between cesarean section and subsequent development of childhood asthma: A population-based cohort study
- Research Article
99
- 10.1016/j.ajog.2005.03.056
- Aug 1, 2005
- American Journal of Obstetrics and Gynecology
The effect of pregnancy and mode of delivery on the prevalence of urinary and fecal incontinence
- Research Article
87
- 10.1016/j.jaci.2005.05.043
- Aug 8, 2005
- Journal of Allergy and Clinical Immunology
Mode of delivery at birth and development of asthma: A population-based cohort study
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