An observational study in Regenerative Medicine, Stem Cell Banking and Perinatal Medical Waste, sponsored by Kayseri City Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Kayseri City Hospital · Observational
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.
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.
Kayseri City Hospital is the lead sponsor of 47 studies on the registry; 17 are open to participants now.
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The study population consisted of 160 healthy women with uncomplicated singleton pregnancies who delivered at term (≥37 weeks) at Kayseri City Hospital and Eskişehir Osmangazi University Hospital in Türkiye. Participants were aged between 18 and 45 years. Perinatal tissues, including amniotic fluid, amniotic membrane, umbilical cord, and placenta, were collected immediately after delivery as medical waste, with no additional intervention applied. All participants provided written informed consent.
Exclusion Criteria:
Samples from this single cohort were divided into five tissue categories (amniotic fluid, amniotic membrane, umbilical cord, placental fragments, whole placenta) for comparative analysis of mesenchymal stem cell yield, sterility, and cost-effectiveness.
Other: Perinatal Tissue Collection
Collection of perinatal medical waste (amniotic fluid, amniotic membrane, umbilical cord, placenta) at the time of term delivery for laboratory-based mesenchymal stem cell isolation and analysis. No therapeutic or interventional procedure was performed on participants.
Viable Mesenchymal Stem Cell Yield
The average number of viable mesenchymal stem cells (MSCs) isolated per perinatal tissue sample (×10⁶ cells per sample).
Time frame: Within 4 weeks after sample collection.
Microbial Contamination Rate
Proportion of perinatal tissue samples testing positive for microbial growth using the BACTEC™ FX system.
Time frame: Within 48 hours after collection.
Cost per Million Viable MSCs
Average total cost (USD) of producing 1×10⁶ viable MSCs, including procurement, storage, isolation, and sterility testing.
Time frame: Calculated during the study period (January-June 2023).
Population Doubling Time (PDT)
The proliferative capacity of MSCs at passage 3, calculated as population doubling time (hours).
Time frame: Assessed at day 6-8 of culture expansion.
Plan to share: No
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Kayseri City Hospital