Nassau

Musculoskeletal disorders and injuries cause significant disability worldwide, affecting people of all ages and leading to pain, limited mobility, and reduced quality of life. This ongoing open-label, single-arm phase IIIa study is evaluating the safety of a human allogeneic bone marrow-derived mesenchymal stromal cell product called StromaForte in patients with musculoskeletal injuries andor degeneration. The study aims to assess safety and changes in pain over one year after treatment with these stem cells. Participants receive 50 million StromaForte cells locally injected under ultrasound guidance at the injury or degeneration site, combined with or without 100 million cells given intravenously over about 30 minutes. If local injection is not possible, only the systemic intravenous treatment is given. Additional doses may be administered with specified minimum intervals between local and systemic doses. Four subgroups based on connective tissue injury or degeneration type are included. During the study, patients are monitored for adverse events up to one year after treatment. Researchers assess pain levels in each injured or degenerated area, quality of life measures using questionnaires, and changes in pain between treatment subgroups. Follow-up can be face-to-face or remote. This comprehensive evaluation will provide data on safety and patient-reported outcomes following StromaForte administration for musculoskeletal conditions.

This research aims to evaluate the safety and preventive effects of an intravenous infusion of a human allogeneic bone-marrow-derived mesenchymal stromal cell product called StromaForte in adults at risk of cardiovascular diseases CVD. Cardiovascular diseases, including coronary heart disease, stroke, and peripheral artery disease, are leading causes of death worldwide, often developing silently over years. The study explores whether early preventive treatment with these stem cells can reduce inflammation and the risk of cardiovascular events over a long period. Participants will receive a single intravenous infusion of 100 million mesenchymal stromal cells formulated in sodium chloride with human serum albumin, administered slowly over approximately 30 minutes. Additional doses may be given at intervals of three months or more, depending on participant choice and eligibility, to assess potential cumulative benefits. This open-label, single-arm trial follows participants over five years, monitoring cardiovascular health and response to treatment. Throughout the study, participants will undergo regular assessments, including monitoring for adverse events within 28 days post-infusion and tracking cardiovascular events up to five years after treatment. Data collected will include cardiovascular risk evaluations, lifestyle and health questionnaires, and, with consent, medical records and additional blood tests. The study aims to understand both the safety of this treatment and its potential role in preventing cardiovascular disease in a diverse group of adults aged 25 to 85 years.

Researchers are conducting a five-year study to evaluate and improve ways to sustain a nationwide HIV prevention program called Focus on Youth in Caribbean plus Caribbean Informed Parents and Children Together FOYCCImPACT in schools. This study uses an adaptive trial design with advanced machine learning to refine strategies and identify the best approaches for teachers and students who may struggle to fully implement or respond to the program. The main goal is to measure how well the program is maintained over time across multiple school settings. The study involves 156 grade 6 teachers in 65 government primary schools delivering FOYCCImPACT over four years, with additional annual booster sessions for students in grades 7 to 9 led by 49 Health and Family Life Education teachers in 30 junior high schools. Teachers who do not meet a benchmark of implementing over 80% of core activities are randomized to receive additional support strategies such as biweekly monitoring and feedback, site-based assistance mentorship, or enhanced mentorship, with adjustments made at multiple stages based on their performance. Participants include teachers and approximately 3,500 students who complete surveys at the start and end of grade 6 and at the end of grades 7, 8, and 9. Researchers collect data from teachers, students, and focus groups to understand factors affecting program implementation, sustainability, and effectiveness. Key outcomes include fidelity of implementation, sustainability, condom use skills, self-efficacy, and other youth behaviors, monitored annually throughout the study period. The study also evaluates inner and outer school contexts and climate to support ongoing program success.