Optimizing the Clinical Use of Perinatal Medical Waste: A Cost-Effectiveness Analysis of Fetal Stem Cell Production
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Viable Mesenchymal Stem Cell Yield
研究概览
简要总结
This observational laboratory-based study was conducted to evaluate the clinical feasibility and cost-effectiveness of mesenchymal stem cell (MSC) production from perinatal medical waste, including umbilical cord, amniotic fluid, amniotic membrane, and placenta. A total of 160 tissue samples were collected from women delivering at term, and standardized protocols were applied for microbial sterility testing, MSC isolation, and cost analysis under Good Manufacturing Practice (GMP) conditions. The study compared MSC yield, contamination rates, and total processing costs across tissue types.
详细描述
Perinatal medical waste, including the umbilical cord, amniotic fluid, amniotic membrane, and placenta, represents a promising and ethically acceptable source of mesenchymal stem cells (MSCs). Unlike bone marrow or adipose-derived MSCs, which require invasive procedures and are limited by donor morbidity and age-related decline, perinatal tissues are collected non-invasively at the time of delivery and are usually discarded. This study was designed to optimize the clinical use of such tissues by systematically comparing their feasibility for large-scale MSC banking under Good Manufacturing Practice (GMP) conditions.
This prospective observational study was conducted between January and June 2023 at Eskişehir Osmangazi University and Kayseri City Hospital. A total of 160 perinatal tissue samples were collected at term deliveries, including amniotic fluid, amniotic membrane, umbilical cord (Wharton's jelly), whole placenta, and placental fragments. Samples were transferred to the GMP-compliant Cellular Therapy and Stem Cell Production Center for laboratory processing. Microbial contamination was assessed using the automated BACTEC™ FX system. MSCs were isolated through tissue-specific protocols, expanded in culture to passage 3, and characterized based on morphology and adherence criteria established by the International Society for Cellular Therapy (ISCT).
Quantitative outcomes included viable MSC yield per sample, sterility outcomes, and proliferative capacity. A detailed cost-effectiveness analysis was also performed, incorporating procurement, transportation, storage, reagents, disposables, and technician labor. Costs were standardized per 1×10⁶ viable MSCs and expressed in U.S. dollars according to the average 2023 exchange rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants only
- •Age between 18 and 45 years
- •Singleton, uncomplicated term pregnancies (≥37 weeks of gestation)
- •Delivery by either elective cesarean section or spontaneous vaginal birth
- •Written informed consent obtained prior to sample collection
排除标准
- •Presence of maternal infection at the time of delivery
- •Known fetal malformations or chromosomal abnormalities
- •Placental abnormalities (e.g., previa, abruption)
- •Preterm labor (<37 weeks)
- •Any maternal comorbidity that may compromise tissue quality (e.g., uncontrolled diabetes, hypertension, autoimmune disease)
- •Inability or unwillingness to provide informed consent
结局指标
主要结局
Viable Mesenchymal Stem Cell Yield
时间窗: Within 4 weeks after sample collection.
The average number of viable mesenchymal stem cells (MSCs) isolated per perinatal tissue sample (×10⁶ cells per sample).
次要结局
- Microbial Contamination Rate(Within 48 hours after collection.)
- Cost per Million Viable MSCs(Calculated during the study period (January-June 2023).)
- Population Doubling Time (PDT)(Assessed at day 6-8 of culture expansion.)
研究者
Mehmet Copuroglu
M.D.
Kayseri City Hospital