Informatics Approaches for Harmonized Intelligent Integration of Stem Cell Research

J Finkelstein, I Parvanova, F Zhang - Stem Cells and Cloning: Advances and Applications 2020, Vol. 13 1-20

As biomedical data integration and analytics play an increasing role in the field of stem cell research, it becomes important to develop ways to standardize, aggregate, and share data among researchers. For this reason, many databases have been developed in recent years in an attempt to systematically warehouse data from different stem cell projects and experiments at the same time… The aim of this scoping review is to characterize the main features of available stem cell databases in order to identify specifications useful for implementation in future stem cell databases…

Expediting Drug Development: FDA's New Regenerative Medicine Advanced Therapy Designation

A Vaggelas, D Seimetz - Therapeutic Innovation & Regulatory Science 2019, Vol. 53(3) 364-373

…In March 2017, the US FDA introduced the new Regenerative Medicine Advanced Therapy (RMAT) designation thus recognizing the enormous potential of these medicines and the need for efficient regulatory tools to accelerate their development and their commercial …

Current state of US Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon

M Mendicino, Y Fan, D Griffin, KC Gunter, K Nichols - Cytotherapy, 2019, Vol. 21(7) 699-724

… vital new legislation affecting the CGT field, such as the Regenerative Medicine Advanced Therapy (RMAT) designation…

Introducing an Ontology-Driven Pipeline for the Identification of Common Data Elements

Elghafari A, Finkelstein J. Introducing an Ontology-Driven Pipeline for the Identification of Common Data Elements. Stud Health Technol Inform. 2020;272:379-382. doi:10.3233/SHTI200574

Common Data Elements (CDEs) are necessary for ensuring data sharing across studies, providing comparability, and enabling aggregation and meta-analyses. The process of developing a set of CDEs for a given clinical research area has typically been arduous and time-consuming. In this work we introduce …

Towards Intelligent Integration and Sharing of Stem Cell Research Data

Borziak K, Qi T, Evangelista JE, Clarke DJB, Ma'ayan A, Finkelstein J. Towards Intelligent Integration and Sharing of Stem Cell Research Data. Stud Health Technol Inform. 2020;272:334-337. doi:10.3233/SHTI200563

Advancements in regenerative medicine have brought to the fore the need for increased standardization and sharing of stem cell product characterization to help drive these innovative interventions toward public availability. Although numerous attempts have been made to store this data, there is still a lack of a platform that …

Data Integration Approaches for Representing Stem Cell Studies

Parvanova I, Finkelstein J. Data Integration Approaches for Representing Stem Cell Studies. Stud Health Technol Inform. 2020;270:1235-1236. doi:10.3233/SHTI200379

The aim of this study was to examine existing methods for sharing results of stem cell research via online data repositories. To identify the relevant repositories, a PubMed search was conducted using standard MeSH terms which was followed by a web-based search of relevant databases. The search yielded 16 databases created between 2010 and 2019. The review of databases identified 35 major rubrics and their sub-rubrics organized in a five-module system. Data integration approaches were characterized by three domains (common data elements, data visualization and analysis tools, and ontology mapping) which varied widely across the databases. Current state of stem cell data integration lacks reproducibility and standardization. Standardization of data integration approaches for representing stem cell studies is necessary to facilitate data sharing.

Disparities in Racial and Ethnic Representation in Stem Cell Clinical Trials

Parvanova I, Finkelstein J. Disparities in Racial and Ethnic Representation in Stem Cell Clinical Trials. Stud Health Technol Inform. 2020;272:358-361. doi:10.3233/SHTI200569 (CTG) provides integrated access to structured records of thousands of randomized clinical trials (RCT). CTG functionality allows download of the entire dataset in XML format for further knowledge discovery and analytics. This study represents an instructive use case of utilizing this functionality for identifying patient representation disparities in stem cell RCTs. The goal of this study was to determine the racial and ethnic composition of stem cell clinical trials and to identify potential disparities in minority representation. The clinical trial registration portal was queried to identify stem cell trials and to compare their racial and ethnic composition to the US population data. Based on our analysis of 248 available trials, we have concluded that not all races and ethnicities are adequately represented in US stem cell trials; thus, concerted efforts are warranted for more inclusive representation of minorities in future stem cell trials.