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Multicenter cell processing for cardiovascular regenerative medicine applications: the Cardiovascular Cell Therapy
Adrian P Gee1, Sara Richman, April Durett
1Center for Cell and Gene Therapy, Baylor College of Medicine, MC3-3320, Feigin Center, 102 Bates Street, Houston, TX 77030, USA.
Cytotherapy
|June 8, 2010
Summary
Standardized cell processing infrastructure for multicenter clinical trials ensures uniform product quality. This approach enables local facilities to successfully support complex cell therapy and regenerative medicine protocols with centralized training and quality control.
Area of Science:
- Cellular Therapy
- Regenerative Medicine
- Clinical Trial Infrastructure
Background:
- Multicenter cellular therapy trials necessitate standardized cell processing and quality control (QC).
- The Cardiovascular Cell Therapy Research Network (CCTRN) required a robust infrastructure for its clinical trials.
Purpose of the Study:
- To develop and implement standardized cell-processing protocols and QC mechanisms for the CCTRN.
- To evaluate the manufacturing results for the initial 60 patients within this infrastructure.
Main Methods:
- Autologous bone marrow (BM) mononuclear cells were processed using a standardized Sepax device at five facilities.
- Centralized training and proficiency evaluation for processing staff were conducted.
- A central QC program, including biorepository product evaluation, monitored product quality.
Main Results:
- Uniform cell products meeting all release criteria were manufactured at all five sites within 7 hours of BM receipt.
- Automated systems (Sepax, Endosafe), standardized procedures, and centralized QC facilitated product uniformity.
- Data from the first 60 procedures confirmed successful implementation of the infrastructure.
Conclusions:
- Complex multicenter cell therapy and regenerative medicine protocols can utilize local processing facilities effectively.
- An established infrastructure for training and QC is crucial for successful decentralized cell manufacturing.
