Clinical Trial

Heart Failure

RESTEM has partnered with the University of Florida on this Phase I clinical trial evaluating the use of our umbilical cord lining stem cells (ULSCs) in the treatment of patients with significant risk of gastrointestinal bleeding, a common complication associated with left ventricular assist devices (LVAD). The uSTOP study, (Utilization of umbilical cord lining Stem cells TO Prevent LVAD associated angiodysplastic bleeding), is an FDA-cleared, dose escalation study that has completed enrollment with 9 patients treated. The study design is focused on stabilizing vasculature and reducing bleeding events.

Left ventricular assist devices are commonly used in patients with severe heart failure to improve heart function, providing a higher quality of life. These devices have been shown to provide significant improvement in survival in patients either awaiting heart transplant or patients deemed poor surgical candidates. While these devices can be beneficial, a significant percentage of patients with an LVAD experience gastrointestinal bleeding which is believed to be due to systemic inflammation and associated vascular fragility, resulting in increased risk of hospitalization and impaired recovery. To Early clinical data has suggested that cellular therapy may represent a promising approach to manage these bleeding complications as well as the associated systemic inflammation.

We have successfully completed recruitment and treatment of Phase I participants and the data suggest improvements which merit further investigation. A Phase II study is planned that will evaluate the improvements observed in a larger cohort of patients with the overarching goal of bringing this next-generation therapy to routine clinical care.

To learn more about this trial, visit: u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding – Full Text View – ClinicalTrials.gov

If you are interested in learning more or getting involved, please contact us.