Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.


Trial ID: NCT02032004


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

Stanford Investigator(s)

Phillip C. Yang, MD
Phillip C. Yang, MD

Professor of Medicine (Cardiovascular Medicine)


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


other: Sham Comparator

biological: Allogeneic Mesenchymal Precursor Cells (MPCs)


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305