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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01781390 | Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction | PHASE2 | COMPLETED | 106 | — | — | Mar 11, 2013 | Apr 6, 2021 | Jun 23, 2022 | - | — |
Safety measure: An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received matching-placebo solution 2 milliliters per minute (mL/min) infused Intracoronary for 60 min including line flush \[0 Mesenchymal Precursor Cells (MPCs)/min\] on Day 0. |
| Mesenchymal Precursor Cells (MPC) 12.5 M | EXPERIMENTAL | Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10\^5 MPCs/min) on Day 0. |
| Mesenchymal Precursor Cells (MPC) 25 M | EXPERIMENTAL | Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10\^5 MPCs/min) on Day 0. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Matching placebo solution for infusion. |
| Mesenchymal Precursor Cells (MPC) 12.5 M | BIOLOGICAL | MPC 12.5 M solution for infusion. |
| Mesenchymal Precursor Cells (MPC) 25 M | BIOLOGICAL | MPC 25 M solution for infusion. |
Key Inclusion Criteria: * Clinical symptoms consistent with acute myocardial infarct (AMI) (pain, etc.) for a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI). * De Novo anterior AMI. * Successful revascularization of the culprit lesion. Key Exclusion Criteria...