Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study).

ABSTRACT:

Rationale

Cell dose and concentration play crucial roles in phenotypic responses to cell-based therapy for heart failure.

Objective

To compare the safety and efficacy of 2 doses of allogeneic bone marrow-derived human mesenchymal stem cells identically delivered in patients with ischemic cardiomyopathy.

Methods and results

Thirty patients with ischemic cardiomyopathy received in a blinded manner either 20 million (n=15) or 100 million (n=15) allogeneic human mesenchymal stem cells via transendocardial injection (0.5 cc per injection × 10 injections per patient). Patients were followed for 12 months for safety and efficacy end points. There were no treatment-emergent serious adverse events at 30 days or treatment-related serious adverse events at 12 months. The Major A

SUBMITTER: Florea V 

PROVIDER: S-EPMC8742223 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature