Nassau

Musculoskeletal disorders and injuries are a leading cause of disability worldwide, affecting people of all ages and significantly reducing quality of life by limiting mobility and causing pain. These conditions also create a large financial burden due to increased healthcare costs and lost productivity. This study evaluates the safety of a human allogeneic bone marrow-derived mesenchymal stromal cell product, called StromaForte, in patients with musculoskeletal injuries or degeneration, aiming to explore its potential to help restore function and reduce pain. Participants will receive an injection of 50 million allogeneic bone marrow-derived mesenchymal stromal cells locally at the site of injury or degeneration, guided by ultrasound for precise delivery. In some cases, an additional 100 million cells may be given intravenously over about 30 minutes if local injection is not feasible. This open-label, single-arm phase I/IIa study assesses safety and allows for an additional dose if needed. Throughout the study, participants will be monitored for safety by recording adverse events at multiple time points up to one year after treatment. Researchers will also track changes in pain levels in each affected area. The study includes both in-person and remote follow-ups, involving assessments of pain and safety to evaluate the effects of the cell therapy over time.

Researchers are evaluating the safety and preventive effects of an intravenous infusion of a stem cell product called StromaForte, derived from human bone marrow mesenchymal stromal cells, in individuals at risk for cardiovascular diseases (CVD). CVD includes heart and blood vessel disorders such as heart attacks and strokes, which are leading causes of death worldwide. The study aims to assess safety by tracking adverse events within 28 days after treatment and to explore whether the stem cells can reduce cardiovascular events over a five-year period. This trial is a Phase I/II clinical study involving participants aged 25 to 85 years. Participants will receive a slow intravenous infusion of 100 million allogeneic bone marrow-derived mesenchymal stromal cells formulated with sodium chloride and human serum albumin over approximately 30 minutes. Doses may be repeated at intervals of at least three months to study potential cumulative effects. The study is single-arm and open-label, meaning all participants receive the stem cell treatment and are followed over time to observe outcomes. Throughout the study, participants will be monitored for safety, including the number and severity of side effects, using established criteria within the first 28 days post-infusion. Long-term follow-up will include assessments of cardiovascular events for up to five years. Researchers will collect data on participants' lifestyle, risk scores, medical records, scans, and blood tests, with participants' consent, to better understand how the stem cell treatment affects disease development and to compare results with matched populations from real-world data registries.

Researchers are evaluating a five-year hybrid type 3 effectiveness-implementation study to sustain a nationwide HIV prevention curriculum called Focus on Youth in the Caribbean plus Caribbean Informed Parents and Children Together (FOYC+CImPACT) in schools. This study uses advanced machine learning and a Sequential, Multiple Assignment, Randomized Trial (SMART) design to improve and personalize implementation strategies. The goal is to identify the best ways to support teachers and students who may not fully respond to the program and to understand factors influencing program sustainability. The study involves 156 grade 6 teachers delivering FOYC+CImPACT in 65 government primary schools over four years, with annual booster sessions led by 49 Health and Family Life Education (HFLE) teachers in 30 junior high schools. Interventions include biweekly monitoring and feedback for teachers, site-based assistance and mentorship led by high-performing teachers, and enhanced mentorship by experienced FOYC coaches offering tailored support, text messaging, and networking opportunities. FOYC is an eight-session life skills curriculum focused on reducing HIV/STI risks and teen pregnancy, combined with a single-session parent-adolescent communication intervention using educational video and role-plays. Participants will include approximately 3,500 students in grades 6 through 9 who will complete surveys at multiple points during the study. Researchers will collect data from teachers, students, and focus groups to measure program implementation fidelity, sustainability, condom use skills and behavior, self-efficacy, and contextual factors affecting success. The study will monitor progress yearly over four years to understand how well the program is maintained and to assess impacts on student outcomes related to HIV prevention.