TEVA C41750/3100 (DREAM-HF) Study

Condition/Intervention:

  • Heart Failure

Study Name:

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

Phase:

Phase 3

Summary:

This research study is designed to test the investigational use of CEP-41750 (mesenchymal precursor cells) in patients with chronic heart failure. Researchers will examine whether injecting the cells into heart muscle with a specific type of needle can help restore heart muscle function.

The study will compare CEP-41750 to the standard treatment (standard of care for heart failure). Participants will receive either CEP-41750 or undergo a partial procedure and will not receive CEP-41750.

Key Inclusion Criteria:

  • 18 to 80 years of age
  • Diagnosis of chronic heart failure of ischemic or non-ischemic etiology
  • On stable, optimally tolerated dosages of heart failure therapies
  • On a stable, outpatient, oral diuretic dosing regimen
  • Not a candidate for either percutaneous coronary intervention or coronary artery bypass graft surgery

Key Exclusion Criteria:

  • New York Heart Association Functional Class I or Functional Class IV symptoms
  • Acute myocardial infarction within one month before screening procedures
  • Unstable angina pectoris within one month before screening procedures
  • Peri-/postpartum cardiomyopathy
  • Ischemic or hemorrhagic stroke within three months prior to enrollment

Please see complete list of inclusion and exclusion criteria.

Principal Investigators:

David Chang, MD
Timothy Henry, MD

Co-Investigators:

Michele Hamilton, MD
Jon Kobashigawa, MD
Jaime Moriguchi, MD
Antoine Hage, MD
Jignesh Patel, MD, PhD
Michelle Kittleson, MD, PhD
Lawrence Czer, MD
Babak Azarbal, MD
Dael Geft, MD
Mamoo Nakamura, MD

Study Coordinator and Contact:

Tracey Early
Phone: 310-423-1231
Email: tracey.early@cshs.org

Maria Thottam
Phone: 310-248-7136
Email: maria.thottam@cshs.org

Status:

Active

IRB No.:

35633

Date Last Updated:

04/15