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

NCT07169838 | Completed

• 2 other identifiers: KayseriCityHospital28/2023
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mesenchymal Stem Cells; Perinatal Medical Waste; Umbilical Cord; Stem Cell Banking; Cost-Effectiveness

Outcome Measures

Primary Outcomes (1)

• Viable Mesenchymal Stem Cell Yield

  The average number of viable mesenchymal stem cells (MSCs) isolated per perinatal tissue sample (×10⁶ cells per sample).

  Within 4 weeks after sample collection.

Secondary Outcomes (3)

• 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.

Study Arms (1)

Pregnant women at term delivery providing perinatal tissue samples

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

Interventions

Perinatal Tissue Collection OTHER

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.

Pregnant women at term delivery providing perinatal tissue samples

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female participants only, as the study involved collection of perinatal tissues (amniotic fluid, membranes, umbilical cord, placenta) at the time of childbirth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kayseri, 38130, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: September 12, 2025
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)