Chronic Heart Failure
Conditions
Keywords
Chronic Heart Failure, CHF, Left Ventricular Systolic Dysfunction, Ischemic Heart Failure, Nonischemic Heart Failure, Stem Cells, Allogeneic Mesenchymal Precursor Cells, Inflammation
Brief summary
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.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) for improvement in clinical outcomes (heart failure major adverse cardiac events \[HF-MACE\]), preventing further adverse cardiac remodeling (left ventricular end systolic volume \[LVESV\] and left ventricular end-diastolic volume \[LVEDV\]), and increasing exercise capacity (six-minute walking test \[6MWT\]) in participants with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.
Interventions
BIOLOGICALRexlemestrocel-L
Rexlemestrocel-L consists of human bone marrow-derived allogeneic mesenchymal precursor cells (MPCs) isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo, and cryopreserved.
OTHERSham Comparator
The sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L.
Sponsors
Mesoblast, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The participant is 18 to 80 years of age, inclusive; both men and women will be enrolled. * The participant has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months * The participant 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 participant is on a stable, outpatient, oral diuretic dosing regimen in which the participant remains clinically stable during screening. * Other Criteria apply, please contact the investigator
Exclusion criteria
* The participant has NYHA Functional Class I or Functional Class IV symptoms. * Other Criteria apply, please contact the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE) | Up to 71 months | Non-fatal decompensated heart failure (HF) event was adjudicated when the diagnosis of a nonfatal decompensated HF event demonstrated the presence of signs and symptoms consistent with clinical decompensation of the participant's HF state requiring an in-hospital stay or intravenous (IV) diuretic therapy or aquapheresis during an urgent care outpatient HF visit. TCEs were defined as a composite of cardiac death, left ventricular assist device (LVAD) placement, heart transplant, or artificial heart implantation. Adjudication of all potential non-fatal HF-MACE or TCEs was performed by an independent, blinded Clinical Endpoints Adjudication Committee (CEC) based on the cardiac adjudication manual. Negative number in the time to event range indicates that event occurred to the subject before treatment. |
Countries
Canada, United States
Contacts
STUDY_DIRECTOREric Rose, MD
Mesoblast, Ltd.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 10.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 265 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 59 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 431 Participants |
| Sex: Female, Male Female | 122 Participants |
| Sex: Female, Male Male | 221 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 74 / 282 | 79 / 283 |
| other Total, other adverse events | 260 / 276 | 244 / 261 |
| serious Total, serious adverse events | 191 / 276 | 170 / 261 |
Outcome results
None listed