u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding

Summary

This is a Phase I, single ascending dose, first in human, open-label, non-controlled, dose-escalation trial that will investigate intravenous infusions of Umbilical cord lining stem cells (UCLSCs) in Left Ventricular Assist Device (LVAD) patients. This study will recruit patients from the Advanced Heart Failure and LVAD Clinic at the University of Florida, including recently implanted patients, as well as patients on chronic long-term support, with the goal of enrolling up to 9 subjects to participate in the study.

Timeline

Start

2021-11-01

Primary completion

2023-07-27

Completion

2023-07-27

Publications

• Ahmed MM, Meece LE, Handberg EM, Pepine CJ. Intravenous administration of umbilical cord lining stem cells in left ventricular assist device recipient: Rationale and design of the uSTOP LVAD BLEED pilot study. Am Heart J Plus. 2022 May 8;16:100142. doi: 10.1016/j.ahjo.2022.100142. eCollection 2022 Apr.

Drugs

Indications