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

Kayseri City Hospital

Status: Completed

Conditions: Umbilical Cord Stem Cells; Stem Cell Banking; Perinatal Medical Waste; Regenerative Medicine

Treatments: Other: Perinatal Tissue Collection

Study type: Observational

Funder types: Other

Identifiers

NCT07169838

28/2023 (Other Identifier)

KayseriCityHospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Pregnant women at term delivery providing perinatal tissue samples

Description:

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.

Treatment:

Other: Perinatal Tissue Collection