©2024 Stanford Medicine
Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.
Recruiting
Trial ID: NCT02032004
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
Stanford Investigator(s)
Phillip C. Yang, MD
Professor of Medicine (Cardiovascular Medicine)
Eligibility
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
Intervention(s):
other: Sham Comparator
biological: Allogeneic Mesenchymal Precursor Cells (MPCs)
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305