Acute respiratory distress syndrome (ARDS) in COVID‐19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti‐inflammatory effects and could yield beneficial effects in COVID‐19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC‐MSC) infusions in subjects with COVID‐19 ARDS. A double‐blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty‐four subjects were randomized 1:1 to either UC‐MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC‐MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 106 UC‐MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion‐associated AEs. No serious adverse events (SAEs) were observed related to UC‐MSC infusions. UC‐MSC infusions in COVID‐19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC‐MSC‐treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE‐free survival (P = .008), and time to recovery (P = .03). UC‐MSC infusions are safe and could be beneficial in treating subjects with COVID‐19 ARDS.

Recruitment is one of the most significant challenges in conducting research with ethnic minority populations. Establishing relationships with organizations that serve ethnic minority communities can facilitate recruitment. To create a successful recruitment process, a strategic plan of action is necessary prior to implementing community outreach efforts. For this study population of women who were HIV+ and recovering from substance abuse disorder, the authors found that establishing trust with community organizations that serve these women allows for a productive referral relationship. Although the majority of women in this study are African American, the authors were particularly challenged in recruiting Hispanic women. This article presents a recruitment process model that has facilitated our recruitment efforts and has helped the authors to organize, document, and evaluate their community outreach strategies. This model can be adopted and adapted by nurses and other health researchers to enhance engagement of minority populations. Keywords recruitment; minorities; community; engagement; outreach Despite recent efforts by the National Institutes of Health (NIH) to promote research that includes women and minorities (U.S. Department of Health and Human Services [USDHHS], 2003), there is a risk of continued underrepresentation of minority group members and women in health research because of barriers to research participation. Although special recruitment efforts are clearly needed to overcome these barriers (Atkinson & Flint, 2001;Brown, Fouad, Basen-Engquist, & Tortolero-Luna, 2000;Escobar-Chaves, Tortolero, Mâsse, Watson, & Fulton, 2002;Gilliss et al., 2001;Marquez, Muhs, Tosomeen, Riggs, & Melton, 2003), few reports have proposed working with community organizations and leaders explicitly for this purpose. Many of those who suggest working with such contacts have not described the process of establishing relationships between researchers and the community. We have used our experiences in attempting to recruit a culturally representative sample of women who were HIV+ for a behavioral study on HIV medication adherence and substance abuse recovery to NIH Public Access HIV/AIDS and Substance Abuse DisparitiesEthnic minority groups have been found to be at an increased risk for sexually transmitted diseases and substance abuse. Specifically, HIV/AIDS with co-occurring substance abuse disorders are devastating health problems that disproportionately affect minority populations (aCenters for Disease Control and Prevention [CDC], 2005a[CDC], , 2005cHessol et al., 2001 1997;Warren-Findlow, Prohaska, & Freedman, 2003). Difficulties in Engaging Minority WomenRecruiting ethnic minorities to participate in clinical research is more challenging and costly than recruiting participants from the ethnic majority (Escobar-Chaves et al., 2002;Levkoff & Sanchez, 2003;Marquez et al., 2003;Shavers-Hornaday & Lynch, 1997). African Americans are often distrustful of medical researchers for many reasons, including the his...

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et al. Chronic exposure to ambient levels of urban particles affects mouse lung development.