Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02032004 | Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure | PHASE3 | COMPLETED | 565 | — | — | Mar 3, 2014 | Jan 30, 2020 | Mar 23, 2026 | 59 | United States, Canada |
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.
| Arm | Type | Description |
|---|---|---|
| Sham Control | SHAM_COMPARATOR | Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results. |
| Rexlemestrocel-L | EXPERIMENTAL | Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results. |
| Name | Type | Description |
|---|---|---|
| Rexlemestrocel-L | BIOLOGICAL | 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. |
| Sham Comparator | OTHER | The sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L. |
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 inclu...