In recent years there have been significant increases in the opportunities for treatment of multiple diseases from cellular-based therapies. This includes treatments using cellular-based therapies in oncology, hematologic diseases, cartilage repair, diabetes, and initial work in cardiac and vascular repair. There are a broad range of products and proposed indications for use including tumor-infiltrating lymphocytes, activated T lymphocytes for treatment of viral infections, a marketed cartilage cellular product for treatment of cartilage injuries, and islet cell transplant for treatment of diabetes. Cell-based therapies for blood diseases most likely will include allogeneic cell lines to support blood component reconstitution and/or immune function. The challenge for this project hinges on the ability to produce cellular products that meet regulatory standards for use in clinical trials. This proposal describes a comprehensive Data and Coordinating Center (DCC) for the Specialized Centers of Cell-based Therapy (SCCT).
The specific aims of this application are to: provide administrative support;facilitate communication between centers;facilitate planning and conducting of research including consultation on study design and analysis;provide meeting support for SCCT centers, Steering Committee, Protocol Review Committee and Data and Safety Monitoring Board;monitor center performance;administer SCCT funds for clinical studies;provide regulatory guidance on federal regulatory requirements, including protection of human subjects and inclusion of children, women and minorities;establish and maintain a web-based database for cell-based therapy including cellular product characteristics and preclinical and clinical outcome data;assess availability and potential use of existing databases including development of common data elements;provide a web-based catalog of cellular products for potential use in preclinical and clinical studies;and ensure high quality and comprehensive databases through data quality control checks and education to SCCT centers. (End of abstract) INDIVIDUAL PROJECTS AND CORE UNITS: Project 1. Specialized Centers for Cell-Based Therapy for NHLBI and Data and Coordinating Center (Carter, Shelly) DESCRIPTION (provided by applicant): In recent years there have been significant increases in the opportunities for treatment of multiple diseases from cellular-based therapies. This includes treatments using cellular-based therapies in oncology, hematologic diseases, cartilage repair, diabetes, and initial work in cardiac and vascular repair. There are a broad range of products and proposed indications for use including tumor-infiltrating lymphocytes, activated T lymphocytes for treatment of viral infections, a marketed cartilage cellular product for treatment of cartilage injuries, and islet cell transplant for treatment of diabetes. Cell-based therapies for blood diseases most likely will include allogeneic cell lines to support blood component reconstitution and/or immune function. The challenge for this project hinges on the ability to produce cellular products that meet regulatory standards for use in clinical trials. This proposal describes a comprehensive Data and Coordinating Center (DCC) for the Specialized Centers of. Cell-based Therapy (SCCT).
The specific aims of this application are to: provide administrative support;facilitate communication between centers;facilitate planning and conducting of research including consultation on study design and analysis;provide meeting support for SCCT centers, Steering Committee, Protocol Review Committee and Data and Safety Monitoring Board; monitor center performance;administer SCCT funds for clinical studies;provide regulatory guidance on federal regulatory requirements, including protection of human subjects and inclusion of children, women and minorities;establish and maintain a web-based database for cell-based therapy including cellular product characteristics and preclinical and clinical outcome data;assess availability and potential use of existing databases including development of common data elements;provide a web-based catalog of cellular products for potential use in preclinical and clinical studies;and ensure high quality and comprehensive databases through data quality control checks and education to SCCT centers.
