Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.
Trial ID or NCT#
NCT02032004
Status
RECRUITING
Purpose
The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived mesenchymal precursor cells (MPCs [rexlemestrocel-L]) is effective in the treatment of chronic heart failure (HF) due to left ventricular (LV) systolic dysfunction.
Official Title
Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic) Dream HF-1
Eligibility Criteria
Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled. - The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months - The patient is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month before study intervention - The patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening. - Other Criteria apply, please contact the investigator
Exclusion Criteria:
- - The patient has NYHA Functional Class I or Functional Class IV symptoms. - Other Criteria apply, please contact the investigator
Investigator(s)
View on ClinicalTrials.gov
