NCT07169838

Comparative Study of Perinatal Tissues for Clinical-Grade Mesenchymal Stem Cell Production and Cost-Effectiveness

Optimizing the Clinical Use of Perinatal Medical Waste: A Cost-Effectiveness Analysis of Fetal Stem Cell Production

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Kayseri City Hospital · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Regenerative Medicine
• Stem Cell Banking
• Perinatal Medical Waste
• Umbilical Cord Stem Cells

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-06-01
• Completion: 2025-08-01
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: Turkey (Türkiye)