Clinical potential of human amniotic fluid stem cells

Objectives To determine whether amniotic fluid derived stem cells maintain their stem cell characteristics (a) after processing by a licensed cell therapy center and (b) after the cells undergo simulated clinical application. Methods Amniotic fluid was collected by laparotomy - a small uterine incision was made at proposed site for delivery and a sterile catheter inserted to collect fluid into a sterile bag. After flow stopped the catheter was withdrawn, the cesarean completed and the collected fluid delivered to the cell therapy center for processing and cryostorage. A clinical setting was simulated where amniotic fluid cells received from cell therapy center were thawed at room temperature for a maximum of 3 h and passed through a clinical cell delivery device to monitor cell viability. The cells were examined for viability, stability, growth, differentiation, and markers of stemness. Results Amniotic fluid stem cells processed from a clinical cell therapy center behave similarly to amniotic fluid stem cells processed in a research laboratory with respects to viability, stability, growth, differentiation and maintain markers of stemness. There were differences due to heterogeneity of samples which were not methodological. Growth in cell culture and differentiation were satisfactory. Simulation of treating the cells in a clinical environment show a general stability in viability of amniotic fluid cells at room temperature for 3 h minimum and when passed through a clinically approved delivery device. Conclusions The data indicate human amniotic fluid processed in a clinical facility could be used therapeutically if proven to be safe.

Automated summary

This study investigated whether amniotic fluid-derived stem cells maintained their stem cell characteristics after processing by a licensed cell therapy center and simulated clinical application. The results showed that amniotic fluid stem cells processed in a clinical cell therapy center behaved similarly to those processed in a research laboratory, exhibiting viability, stability, growth, differentiation, and markers of stemness. The study also found that amniotic fluid cells maintained a stable viability at room temperature for a minimum of 3 hours when passed through a clinically approved delivery device. These findings suggest that human amniotic fluid processed in a clinical facility may have therapeutic potential if proven safe.