Placental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Development of placental 3D organoid model
研究概览
简要总结
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.
详细描述
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization. Placental organoid model can be used in the study of placental pathophysiology. In in particular, it provides a personalized model for sartorial in vitro evaluation of personalized therapeutic efficacy of different pharmacological therapies. In particular, with placental organoid it is possible to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with uncomplicated normal term pregnancy undergoing elective cesarean section for previous uterine surgery or breech presentation of the fetus;
- •Patients with retained abortion and history of recurrent abortion sine causa at the end of the work-up of investigations performed according to ESHRE guidelines, undergoing revision of the uterine cavity;
- •Patients diagnosed with preeclampsia, defined in accordance with the definitions of ISSHP, undergoing cesarean section;
- •Patients with preterm onset, before 37 weeks gestational age, of spontaneous labor, undergoing cesarean section in labor for low weight or abnormal fetal presentation.
排除标准
- •Age <18 years;
- •Chronic infection with HIV or HCV;
- •Ongoing malignant neoplasms;
- •Multiple pregnancies;
- •Inability to provide informed informed consent.
结局指标
主要结局
Development of placental 3D organoid model
时间窗: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
Morphological characteristics of placental 3D organoids successfully developed from placentas obtained from full-term physiological pregnancies and pathological conditions (abortion, preeclampsia, preterm delivery). Assessment Parameters: Organoid formation efficiency (%)
Characterization of placental 3D organoid model
时间窗: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
Assessment of cell viability (live/dead staining)
Viability of Placental Organoids
时间窗: From date of caesarean section until the development of placental organoids, until 36 months
Measurement of cell proliferation rate in normal and pathological placental organoids before and after anticoagulant, anti-inflammatory, and immunomodulatory treatments (heparin, aspirin, metformin, IVIg, filgrastim). Assessment Parameters: Cell viability (live/dead staining)
次要结局
- Gene Expression in Placental Organoids(From date of caesarean section until the development of placental organoids, until 36 months)
- Secretome Analysis of Placental Organoids(From date of caesarean section until the development of placental organoids, until 36 months)
- Proliferative Capacity of Placental Organoids(From date of caesarean section until the development of placental organoids, until 36 months)
- Growth capacity of placental organoids(From date of caesarean section until the development of placental organoids, until 36 months)
- Protein expression in placental organoids(From date of caesarean section until the development of placental organoids, until 36 months)