Study Led by Public Health Student Provides Analysis of Key Demographic Information for Clinical Trials in Cell-Based Therapy 

Cell-based therapy has the potential to be used as a novel treatment option for a variety of chronic diseases and conditions. The inclusion of women and minority groups in clinical research is essential for the evaluation of therapeutic responses among different demographic groups. 

In a new study published in Contemporary Clinical Trials Communications, Russell Saltzman, a Master of Science in Public Health candidate at the University of Miami Miller School of Medicine, teamed with a group of scientists to aggregate, summarize, and analyze demographic information collected from participants in clinical trials of regenerative medicine. The purpose of the study was to offer information about the effects of stem cell therapy on the pathophysiology of chronic disease.

“The results of this analysis support the idea that there are differences in enrollment between demographic groups in our cell therapy clinical trials and in future, larger phase studies, this must be rectified,” Saltzman noted.

To conduct the analysis, Saltzman and the team examined voluntary participation rates of different demographic groups in eight cell-based therapy clinical trials. The trials, conducted by the Interdisciplinary Stem Cell Institute at the Miller School of Medicine from 2007 to 2017, enrolled patients with ischemic and non-ischemic cardiomyopathy, idiopathic pulmonary fibrosis, aging-frailty, and Type-2 Diabetes.

The racial and ethnic composition across the various trials showed that 91.6 percent of participants were white, 4.4 percent were black, and 4 percent were of Asian, Native American, or unknown race. Hispanic patients comprised 29 percent of all participants. Among the 251 subjects, 20 percent were women and 80 percent were men. High rates of participation among women were found in some, but not all of the studies.

Findings showed the following:

• Women had satisfactory representation in the trials of dilated cardiomyopathy and aging frailty but were under-represented in the type 2 diabetes mellitus, idiopathic pulmonary fibrosis, and ischemic cardiomyopathy trials
• Hispanic populations were accurately represented in trials for ischemic cardiomyopathy, dilated cardiomyopathy, idiopathic pulmonary fibrosis, but were however under-represented in studies for aging-frailty and type 2 diabetes mellitus
• Black participants were under-represented across all trials except for in the type 2 diabetes mellitus trials.

“This study provides insight into the challenges of achieving representative inclusion in research,” noted Saltzman. “Novel community engagement strategies are necessary to improve inclusion of women and underrepresented minorities in clinical research of cell-based therapy.”

Written by Amanda Torres 

Published on February 11, 2021