Cell Tissue Bank. 2026 Jun 5;27(3):29. doi: 10.1007/s10561-026-10230-6.
ABSTRACT
Cryopreserved human heart valves and cardiovascular tissues (homografts) are essential for the surgical treatment of congenital and acquired valvular diseases, particularly in pediatric patients, where prosthetic options are limited. To address the clinical demand for high-quality grafts in Israel, Sheba Medical Center, the largest tertiary care hospital in Israel, established a Good Manufacturing Practice (GMP) compliant Cardiovascular Tissue Bank within the public health system. This report presents an overview of the bank's operation within the Israeli public health system over seven years, covering donor selection criteria, tissue processing procedures, microbiological safety measures, cryopreservation and distribution, as well as protocol optimization and validation. Between 2018 and early 2025, the tissue bank successfully transitioned from basic sterile techniques to full GMP-grade cleanroom operations, implementing validated protocols for decontamination, packaging, and cryopreservation. During this period, 142 donor hearts were processed, yielding 390 cardiovascular tissues, of which 338 were approved for clinical use and distributed to cardiac surgery centers across Israel. This paper provides a comprehensive operational overview of the Sheba Cardiovascular Tissue Bank from 2018 to 2025, describing protocol refinement, tissue procurement, processing, preservation, regulatory compliance, quality control, and distribution. By combining clinical collaboration, rigorous quality control, and GMP-based infrastructure, the bank plays a pivotal role in ensuring the availability of high-quality cryopreserved homografts for Israeli patients, especially pediatric cases with complex congenital heart disease, and provides a sustainable model for hospital-based cardiovascular tissue banking.
PMID:42243596 | DOI:10.1007/s10561-026-10230-6