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

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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