A Double-blind, Randomized, Sham–procedure–controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (CEP–41750) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology: DREAM HF-1 Phase 3 Study C41750/3100 EudraCT number: 2012-001818-42

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In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:
IRB-14-6345
Thomas Heywood
The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

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

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