About the Facility

The Midwest Stem Cell Therapy Center (MSCTC) has a state-of-the-art GMP facility (FDA registration number FEI: 3011110834) located in the Lied building within the University of Kansas Medical Center. This facility supports the development and processing of clinical-grade stem cells from adult tissues, cord blood, and related materials for clinical trials and scalable processing of cellular products for potential therapeutic use.

Facility Details

The facility includes two fully equipped modular clean room suites specifically designed for cell therapy applications, including processing of autologous stem cells and cell culture to support the generation of cellular products for preclinical research, clinical trials, and therapeutic use.

The operation of the clean room suites is classified and maintained under ISO designation 7/Class 10,000 and follows CFR Title 21, Parts 210 and 211, 21 CFR 1271, and applicable provisions from 21 CFR 820, along with other supporting FDA guidelines.

The clean room suites contain gowning rooms, material pass-throughs, and an independent HEPA-filtered HVAC unit that returns pretreated air to the clean room suites. The HVAC system also provides room pressurization with pressure differentials to minimize material and product migration.

A critical part of containment is achieved through a local dust collection system and by maintaining the processing spaces under a negative pressure cascade. Various critical facility parameters, controls, and laboratory equipment are continuously monitored via a wireless alarm system, with both on- and off-site surveillance and data collection.

The validation of the clean room facility is completed regularly in compliance with FDA guidelines for GMP operations, with a focus on cellular product processing. All areas of the production facility have controlled access and are designed and maintained to meet high standards of regulatory compliance and environmental quality.

The facility's design ensures an orderly flow of raw materials, processes, and personnel, enabling the development, manufacturing, and packaging of adult cell therapy products under GMP standards, ensuring the safe application of any product developed or processed here.

The MSCTC GMP facility is currently operational and serves as a production site for cellular materials for clinical trials. For more information, contact rsoder@kumc.edu.