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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00114452 | Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction | PHASE1 | COMPLETED | 60 | — | — | Mar 22, 2005 | Apr 24, 2008 | Mar 10, 2020 | 15 | United States |
| Arm | Type | Description |
|---|---|---|
| Provacel: Cohort 1 | ACTIVE_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 2 | ACTIVE_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 3 | ACTIVE_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 4 | ACTIVE_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Placebo | PLACEBO_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Name | Type | Description |
|---|---|---|
| Provacel | BIOLOGICAL | ex vivo cultured adult mesenchymal stem cells |
| Placebo | BIOLOGICAL | Placebo |
Inclusion Criteria: * Male or female between 21 and 85 years old * First heart attack within 1 to 10 days Exclusion Criteria: * Positive for HIV 1 and 2 * Previous heart attack * Pacemaker or other device * Pregnant or breastfeeding * Allergic to cow or pig derived products * Previous bone marrow...