Every year, about 700,000 youth arrests occur in the United States, creating significant neurodevelopmental strain; this is especially concerning as most of these youth have early life adversity exposures that may alter brain development. Males, Black, and Latinx youth, and individuals from low socioeconomic status households have disproportionate contact with the juvenile justice system (JJS). Youth confined in the JJS are frequently exposed to threat and abuse, in addition to separation from family and other social supports. Youths’ educational and exploratory behaviors and activities are substantially restricted, and youth are confined to sterile environments that often lack sufficient enrichment resources. In addition to their demonstrated ineffectiveness in preventing future delinquent behaviors, high recidivism rates, and costs, juvenile conditions of confinement likely exacerbate youths’ adversity burden and neurodevelopmentally harm youth during the temporally sensitive window of adolescence. Developmentally appropriate methods that capitalize on adolescents’ unique rehabilitative potential should be instated through interventions that minimize confinement. Such changes would require joint advocacy from the pediatric and behavioral health care communities. “The distinct nature of children, their initial dependent, and developmental state, their unique human potential as well as their vulnerability, all demand the need for more, rather than less, legal and other protection from all forms of violence (United Nations Committee on the Rights of the Child, 2007).”
Mesenchymal stem/stromal cells (MSCs) have been carefully examined to have tremendous potential in regenerative medicine. With their immunomodulatory and regenerative properties, MSCs have numerous applications within the clinical sector. MSCs have the properties of multilineage differentiation, paracrine signaling, and can be isolated from various tissues, which makes them a key candidate for applications in numerous organ systems. To accentuate the importance of MSC therapy for a range of clinical indications, this review highlights MSC-specific studies on the musculoskeletal, nervous, cardiovascular, and immune systems where most trials are reported. Furthermore, an updated list of the different types of MSCs used in clinical trials, as well as the key characteristics of each type of MSCs are included. Many of the studies mentioned revolve around the properties of MSC, such as exosome usage and MSC co-cultures with other cell types. It is worth noting that MSC clinical usage is not limited to these four systems, and MSCs continue to be tested to repair, regenerate, or modulate other diseased or injured organ systems. This review provides an updated compilation of MSCs in clinical trials that paves the way for improvement in the field of MSC therapy.
Objective
To determine the prevalence of clinical trial registration in the International Clinical Trial Registry Platform (ICTRP) for studies from Latin America and the Caribbean (LAC) and to identify the key characteristics that lead to prospective and retrospective registration.
Methods
A cross-sectional study identified published, clinical trial studies through a search of PubMed, LILACS (Latin American and Caribbean Center on Health Sciences Information), and the Cochrane Central Register of Controlled Trials. Studies were included if published on 1 January – 31 December 2015, at least one author was affiliated with at least one LAC country, the clinical trial was conducted in at least one LAC site, and the full text of the article was available. A manual search of reference lists was also conducted. ICTRP registration information and key trial characteristics were compared.
Results
Of 1 502 CT references that met inclusion criteria, 297 were randomly-selected, 90.9% of which were published in English, 65% from Brazil, and 76.8% had a LAC author as the first author. The proportion of CT registered in the ICTRP was 59.9 %, of which 51.7% were registered prospectively. Clinicaltrials.gov was most frequently used registry (84.8%), followed by the
Registro Brasileiro de Ensaios Clínicos
and the
Registro Público Cubano de Ensayos Clínicos
. Key characteristics that favored registration were being in study phase 3 or 4 or being a multi-center study. Data was compared to a similar study from 2013 that reported a registration rate of only 19.8%.
Conclusions
Registration adherence and prospective registration have increased in LAC in recent years, but the proportion of unregistered CT remains high. While there are still many challenges to overcome, the adherence strategies implemented in recent years have proven effective.
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