Clinical feasibility and cost efficiency of perinatal mesenchymal stem cell production under GMP conditions

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

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

Evidence level

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

Browse all related research

Filter the research library by this study's title keywords, author, or publication year.