class=”kwd-title”>Keywords: cell therapy cell therapy product administration cell therapy end result

class=”kwd-title”>Keywords: cell therapy cell therapy product administration cell therapy end result data data collection Copyright notice and Disclaimer The publisher’s final edited version of this article is available at Transfusion See additional content articles in PMC that cite the published article. collected and reported. The Health Resources and Solutions Administration (HRSA) offers provided funds to study the use of cell therapy in the United States with a goal of building a database similar to that founded and maintained from the bone marrow transplant community for years. The European Union has pursued a SANT-1 similar goal. Despite these SANT-1 attempts there is limited published info that explains cell therapy product administration across both cell types and indications. To this end The National Institutes of Health National Heart Lung and Blood Institute (NHLBI) Production Assistance for Cellular Treatments (PACT) system has SANT-1 collected data over the past 10 years within the administration of cell therapy products manufactured within the program. The PACT system was created in 2003 through funding from your NHLBI. The program provides medical cell therapy product developing support to investigators wishing to transition a novel cell therapy from your developmental stage to medical applications within the purview of the NHLBI. PACT is not responsible for directly monitoring the medical tests of investigators receiving PACT-manufactured products. PACT has required collection of standardized information on product manufacturing transport receipt administration and adverse reactions with product administration. The purpose of this data collection is definitely 1) to monitor administration of PACT cell therapy products and 2) to build a product administration database to identify trends or security concerns that may be associated with cell therapy product administrations. All medical tests where PACT offers provided developing support were authorized by local ethics committees. Methods Development of Data Collection Forms and Web-Based Data Collection System The PACT Coordinating Center (CC) the EMMES Corporation was responsible for development of the data collection forms in conjunction with the PACT cell processing facilities. These forms were used by the cell processing facility staff and medical investigators. IL8 The forms were developed in conformance with Food and Drug Administration (FDA) regulations and AABB and the Foundation for the Accreditation of Cellular Therapy (Truth) requirements as relevant. PACT also collaborated with the Center for International Blood and Marrow Transplant Study (CIBMTR) which also experienced a mandate to develop a database on the use of hematopoietic cell therapy products in medical trials. Additionally the forms’ content material was harmonized with the cell therapy selections forms SANT-1 used by the Western Society for Blood and Marrow Transplantation (EBMT). PACT end result data are collected at 3 6 and 12 months after product administration in SANT-1 the medical trial. The following forms were used for medical product data collection: Product Manufacturing Info (including cell type) Product Transport and Receipt (including new or cryopreserved) Product Administration Post-Product Administration (Outcome) Data (started in 2010; end result data was not requested for product administrations prior to 2010) On the Product Administration form the data elements include: Main treatment indicator (cardiovascular pulmonary hematology BMT or additional) Route of administration Whether or not the subject experienced any adverse reactions associated with product administration Type(s) of reactions if relevant Severity of reactions Within the Post-Product Administration Data form the data elements include: Response to cellular therapy related to: Effectiveness endpoint (accomplished/not achieved unfamiliar not evaluated or N/A) Security evaluation (no slight or severe toxicity or unfamiliar) Clinical response (none partial total or unfamiliar) Survival: survival status (alive lifeless or lost to follow up) and main cause of death Additionally the PACT CC was responsible for developing the web-based data collection system. The PACT CC monitored the data for completeness generated questions and implemented database upgrades as needed. Data Collection Methods The paper data collection forms as well as the PACT web-based data collection system (through which data are submitted to the CC) are made accessible to the PACT cell processing.