Publications by authors named "C Celluzzi"
Article Synopsis
- Developing advanced cell therapy products involves defining key concepts like mechanism of action (MOA), potency, and efficacy, which can be challenging but is crucial for success.
- The text introduces a logical framework that aligns with regulatory guidelines and draws on insights from 27 FDA-approved cell therapy products to better understand these concepts.
- It highlights the complexity of correlating potency test results with clinical outcomes, discusses common misconceptions, and emphasizes the need for effective communication among developers throughout the product development process.
Background: Unproven cellular therapies are being offered to patients for a variety of conditions and diseases for which other treatments have failed. The use of untested cellular therapies is a worldwide problem. Practitioners (e.
View Article and Find Full Text PDFAdverse event (AE) and adverse reaction (AR) reporting are key components of patient safety and surveillance systems. Review and analysis of this data yields opportunities for process improvement, product information and interventions, and can lead to improved patient outcomes and donor safety overall. AE and AR reporting for cellular therapy products is fragmented and not well characterized in a central reference.
View Article and Find Full Text PDFBackground Aims: Methods for processing products used for hematopoietic progenitor cell (HPC) transplantation must ensure their safety and efficacy. Personnel training and ongoing competency assessment is critical to this goal. Here we present results from a global survey of methods used by a diverse array of cell processing facilities for the initial training and ongoing competency assessment of key personnel.
View Article and Find Full Text PDFBackground: As hematopoietic stem cell transplantation expands globally, identification of the key elements that make up high-quality training programs will become more important to optimizing collection practices and quality of the products collected.
Study Design And Methods: Multiple-choice and open questions to identify training practices of those collecting hematopoietic progenitor cell-apheresis [HPC(A)] and -cord blood [HPC(CB)] products were distributed via an electronic survey tool worldwide. Data were collected on facility demographics, job descriptions, and the content of training programs including general practices, staff assessment, retraining, and unique program features.