Matt Walker | UF Health
A nonprofit launched Oct. 10th will help connect people with FDA-authorized regenerative medicine clinical trials.
Cell-based therapies are proliferating but it’s not always easy for patients to navigate the world of clinical trials. The average person may not be able to easily identify which clinical trials are legitimate and which ones are not being conducted under regulatory oversight.
TrueTrials is the only platform that provides patients with a curated database of legitimate clinical trials of cell-based therapies. It aims to be the cell-based science version of a Good Housekeeping seal of approval.
Dr. Keith March, director of the University of Florida Center for Regenerative Medicine, who also serves as chair of the TrueTrials advisory board, said the idea for TrueTrials came about in concert with a conversation he had with Dr. Peter Marks, the FDA’s director for the Center for Biologics Evaluation and Research.
“After conceiving the idea of an easy-to-use website with a searchable listing of credible trials, I spoke with Dr. Peter Marks at the FDA about the idea,” March said. “With his advice, I began working with a passionate group of individuals to create a positive place that would transform the rhetoric surrounding the field. Rather than amplifying concerns about regenerative medicine by focusing on ‘bad actors’, we provide awareness and lead them to the credible ones. ‘Go here. Work with this good actor. This is a place you can trust to be conducting trials that are appropriately regulated.’”
March, a practicing cardiologist and biochemist, has been working with the development of cell-based therapeutics for more than two decades, and has led and participated in design of numerous FDA-authorized clinical trials of adult stem and regenerative cell therapies. His research laboratory has focused predominantly on the stem/regenerative cells known as mesenchymal stem cells, especially those found in fat.
March and his team are internationally recognized as leading experts in this area, and were the first to discover that the therapeutic properties of these and similar cells are largely mediated by what the substances release or secrete, known as the secretome.
TrueTrials differs from other clinical trial databases because it only includes U.S.-based facilities providing cell-based therapies within FDA-authorized studies. The nonprofit also offers a map that allows patients to search by specific medical conditions as well as find contact information for trials they are interested in.
“For patients, TrueTrials democratizes access to credible research on cell-based therapies,” according to the organization. “For sponsors and investigators, it accelerates enrollment in trials and increases diversity of patients, including increasing the potential to reach more clinical trial-naïve patients who may not live close to an academic medical center.”
In addition to March, TrueTrials is guided by a board of experts in cell therapy across numerous institutions and organizations. TrueTrials is a free resource for patients. It is also currently free for institutions to list their trials. There will be nominal membership fee starting in 2024 for institutions listing their trials.