Perinatal Medical Waste, Regenerative Medicine, Stem Cell Banking, Umbilical Cord Stem Cells
Conditions
Keywords
Mesenchymal Stem Cells, Perinatal Medical Waste, Umbilical Cord, Stem Cell Banking, Cost-Effectiveness
Brief summary
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.
Detailed description
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.
Interventions
OTHERPerinatal 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.
Sponsors
Kayseri City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viable Mesenchymal Stem Cell Yield | Within 4 weeks after sample collection. | The average number of viable mesenchymal stem cells (MSCs) isolated per perinatal tissue sample (×10⁶ cells per sample). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbial Contamination Rate | Within 48 hours after collection. | Proportion of perinatal tissue samples testing positive for microbial growth using the BACTEC™ FX system. |
| Cost per Million Viable MSCs | Calculated during the study period (January-June 2023). | Average total cost (USD) of producing 1×10⁶ viable MSCs, including procurement, storage, isolation, and sterility testing. |
| Population Doubling Time (PDT) | Assessed at day 6-8 of culture expansion. | The proliferative capacity of MSCs at passage 3, calculated as population doubling time (hours). |
Countries
Turkey (Türkiye)
Outcome results
None listed