Efficacy and Safety of rexlemestrocel-L in Chronic Heart Failure
Research type
Research Study
Full title
A Double-blind, Randomized, Sham–procedure–controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology: DREAM HF-1
IRAS ID
193674
Contact name
Anthony Mathur
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products
Eudract number
2012-001818-42
Duration of Study in the UK
2 years, 2 months, 25 days
Research summary
Heart Failure (HF) has been the leading cause of hospitalization for patients older than 65 years of age globally. Patients who are at the end stage of this disease have less treatment options available.
Clinical trials involving use of cellular therapies, such as stem cells, to repair and/or restore the structure and function of the damaged myocardium have shown promising results. In this study, the investigational product rexlemestrocel-L consists of human bone marrow-derived cells.
About 1165 patients will be enrolled in the study who will be randomly assigned (by chance) in a 1:1 ratio to receive active treatment (ie, intracardiac mapping and transendocardial delivery of rexlemestrocel-L) or control group where they will receive standard of care for heart failure, but will undergo a partial procedure and will not receive rexlemestrocel-L. The study comprises of screening, treatment and follow-up periods. The purpose of this study is to evaluate the efficacy and safety of rexlemestrocel-L in improving clinical outcomes, preventing cardiac remodelling , and increasing exercise capacity in patients with chronic HF.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0084
Date of REC Opinion
27 Apr 2016
REC opinion
Further Information Favourable Opinion