RESCUE-HF Trial: Retrograde Delivery of Allogeneic Umbilical Cord Lining Subepithelial Cells in Patients With Heart Failure

Cell Transplantation
Jorge TumaAmit N Patel

Abstract

Cell therapy is an evolving option for patients with end-stage heart failure. First-generation cell therapy trials have had marginal success. Our goal was to evaluate retrograde delivery of allogeneic umbilical cord subepithelial cells (UCSECs) in patients with heart failure. A prospective open-label dose escalation study of the safety and feasibility of UCSECs infused retrogradely into the coronary sinus was performed. Patients received a single dose of either 100 million (M), 200M, or 400M cells. The patients were followed for 2 years. Twenty-four patients were successfully enrolled in the study. The patients had UCSEC infusion without procedure-related complications. The ejection fraction in patients receiving UCSECs demonstrated improvement compared to baseline; from 25.4% (±5.5) at screening to 34.9% (±4.1) at 12 months. End-systolic diameter decreased significantly from 59.9 (±5.3) mm to 52.6 (±2.7) mm (p < 0.05). Retrograde UCSEC delivery was safe and feasible in all three dosage groups. Patients receiving 200M and 400M UCSECs showed signs of early improvement in left ventricular ejection fraction (LVEF) and remodeling. This study provides the basis for a larger clinical trial in heart failure (HF) patients using the mid...Continue Reading

References

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Citations

Mar 8, 2017·Diseases of the Colon and Rectum·Li SunMassarat Zutshi
Feb 3, 2018·Journal of Cardiovascular Translational Research·Wouter A GathierSteven A J Chamuleau
Mar 14, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Eric J RodenbergAmit N Patel
Dec 29, 2020·American Journal of Perinatology·Goro KuramotoTeruo Okano
Mar 7, 2020·European Journal of Pharmacology·Ziwei LiuXiaohui Zhou

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Methods Mentioned

BETA
flow cytometry

Clinical Trials Mentioned

NCT00130377

Software Mentioned

SAS

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