Clinical feasibility and cost efficiency of perinatal mesenchymal stem cell production under GMP conditions
Scientific Reports, cilt.16, sa.1, 2026 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 16 Sayı: 1
- Basım Tarihi: 2026
- Doi Numarası: 10.1038/s41598-025-32738-9
- Dergi Adı: Scientific Reports
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, Chemical Abstracts Core, MEDLINE, Directory of Open Access Journals
- Anahtar Kelimeler: Amniotic fluid, Cost-effectiveness, Mesenchymal stem cells, Perinatal tissue, Placenta, Regenerative medicine, Sterility, Umbilical cord
- Eskişehir Osmangazi Üniversitesi Adresli: Evet
Özet
Perinatal tissues such as umbilical cord, amniotic fluid, amniotic membrane, and placenta contain mesenchymal stem cells (MSCs) with clinical potential; however, a direct comparison of these sources under Good Manufacturing Practice (GMP) conditions remains limited. To evaluate and compare perinatal tissue types in terms of viable MSC yield, sterility, and GMP-adjusted processing cost in order to identify practically applicable sources for clinical-grade biobanking. A total of 160 perinatal tissue samples were collected from 32 term pregnancies during elective cesarean delivery. Standardized GMP protocols were applied for MSC isolation, sterility screening using automated BACTEC™ culture systems, and immunophenotypic characterization in accordance with ISCT criteria. Multivariate linear regression was used to identify independent predictors of MSC yield. Cost modeling included reagents, labor, and cryostorage within a laboratory-scale GMP setting. Umbilical cord tissue yielded the highest number of viable MSCs (6.5 × 10⁶ ± 0.8 cells/sample), followed by amniotic fluid (5.8 × 10⁶ ± 0.6). Amniotic fluid exhibited the lowest contamination rate (3%), whereas placental tissues demonstrated higher microbial burden (18–21%). Tissue type was the strongest predictor of MSC yield (β = 0.61, p < 0.001). Normalized cost analyses indicated that umbilical cord and amniotic fluid offered the most favorable yield-to-cost profiles. Under current GMP conditions, umbilical cord and amniotic fluid appear to provide the most balanced combination of MSC yield, sterility, and processing cost. These findings support a practical framework for tissue selection and workflow optimization in perinatal MSC biobanking and translational regenerative applications.